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Una intervención compleja para los supervivientes de linfoma con fatiga crónica

2 de noviembre de 2026 actualizado por: Lene Thorsen, Oslo University Hospital

Una intervención compleja para un síntoma complejo: un ensayo controlado aleatorio en supervivientes de linfoma con fatiga crónica

The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Chronic fatigue (CF) is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking.

Today, there is no curative treatment of CF. However, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom.

The project is a two-armed RCT in which chronically fatigued lymphoma survivors are randomized to an interdisciplinary complex intervention or to usual care. Eligible participants will receive written information about the study by mail. Survivors who perceive themselves as having physical and mental fatigue, and who are willing to participate, will be asked to fill out and return the Chalder Fatigue Questionnaire (FQ) to the study coordinator. Those who have chronic fatigue as measured by the FQ will be invited to a medical screening by an oncologist in the project group, for evaluation of inclusion.

The interdisciplinary complex intervention will last for 12 + 12 weeks and include four components; patient education, physical exercise (and follow-up), cognitive behavioral program and nutritional counselling, organized in a systematic way, i.e. a standardized patient care pathway.

All outcomes will be assessed in all participants at four points; pre-intervention (baseline) (T0), post-intervention (12 weeks after baseline) (T1) and at 3-month (T2) and 6-month (T3) after T1. Moreover, selected patient reported outcomes will be assessed in all participants at 12-month (T4) and 24-month (T5) after T1.

Tipo de estudio

Intervencionista

Inscripción (Actual)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Noruega
      • Oslo, Noruega
        • Oslo University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Survivors of Hodgkin and aggressive non-Hodgkin lymphoma
  • Not indolent non-Hodgkin lymphoma
  • Not CNS lymphoma at diagnosis
  • Not second cancer
  • Not ongoing cancer treatment
  • Chronic fatigue measured by Chalder Fatigue Questionnaire
  • Diagnosed 2010-2020
  • Received treatment with curative intent
  • 18 - 70 years old at inclusion
  • > 2 years since last treatment
  • Able to understand the Norwegian language
  • Participation approval from oncologist in the project group

Exclusion Criteria:

  • Persisting fatigue > 1 year before the cancer diagnosis
  • Somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches)
  • Psychiatric or mental disorders (i.e. dementia, severe depression, schizophrenia)
  • Use of stimulants for ADHD
  • Substance abuse disorder

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervención compleja interdisciplinar
Otro: Interdisciplinary complex intervention

The interdisciplinary complex intervention lasts 12 weeks and includes the 4 following components;

Patient-education: a 2-hours group-based digital session, including information about fatigue, training theory, psychological strategies and nutrition, all in relation to chronic fatigue (CF).

Physical exercise program: two weekly sessions with aerobic exercise and resistance training. The participants are instructed to do the same program in the unsupervised sessions as in the supervised sessions. After the first 12 weeks exercise period, the participant and the physiotherapist makes an individually tailored plan for exercise and follow-up the next 12 weeks.

Cognitive behavioral program: 6 group-based online sessions lead by two psychologists, based on elements from cognitive behavioral therapy to reduce and/or manage CF. Each session lasts for 135 minutes.

Nutritional counselling: 3 individual sessions by a clinical dietitian. Each session lasts for 30-60 minutes.
Sin intervención: Usual care

Six months after the intervention period (T3), the participants randomized to usual care will be offered a modified version of the intervention in line with their personally expressed needs.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.
From baseline (T0) to 12 weeks (T1)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
From baseline (T0) to 24 weeks (T2)
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
From baseline (T0) to 36 weeks (T3)
Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
Periodo de tiempo: From post-intervention (T1) to 12-month follow-up (T4)

The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
From post-intervention (T1) to 12-month follow-up (T4)
Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
Periodo de tiempo: From post-intervention (T1) to 24-month follow-up (T5)

The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.

A high score for a functional scale represents a high / healthy level of functioning.
From baseline (T0) to 12 weeks (T1)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.

A high score for a functional scale represents a high / healthy level of functioning.
From baseline (T0) to 24 weeks (T2)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.

A high score for a functional scale represents a high / healthy level of functioning.
From baseline (T0) to 36 weeks (T3)
Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From post-intervention (T1) to 12-month follow-up (T4)

The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.

A high score for a functional scale represents a high / healthy level of functioning.
From post-intervention (T1) to 12-month follow-up (T4)
Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From post-intervention (T1) to 24-month follow-up (T5)

The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.

A high score for a functional scale represents a high / healthy level of functioning.
From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 12 weeks (T1)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 24 weeks (T2)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 36 weeks (T3)
Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From post-intervention (T1) to 12-month follow-up (T4)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From post-intervention (T1) to 12-month follow-up (T4)
Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From post-intervention (T1) to 24-month follow-up (T5)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Participants are asked to report their current work status
From baseline (T0) to 12 weeks (T1)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Participants are asked to report their current work status
From baseline (T0) to 24 weeks (T2)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Participants are asked to report their current work status
From baseline (T0) to 36 weeks (T3)
Change in work status in both groups assessed by questions from the HUNT4-study
Periodo de tiempo: From post-intervention (T1) to 12 months follow-up (T4)

Participants are asked to report their current work status
From post-intervention (T1) to 12 months follow-up (T4)
Change in work status in both groups assessed by questions from the HUNT4-study
Periodo de tiempo: From post-intervention (T1) to 24 months follow-up (T5)

Participants are asked to report their current work status
From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index scale
Periodo de tiempo: From post-intervention (T1) to 12 months follow-up (T4)

Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index scale
Periodo de tiempo: From post-intervention (T1) to 24 months follow-up (T5)

Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
Periodo de tiempo: From post-intervention (T1) to 12 months follow-up (T4)

Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
Periodo de tiempo: From post-intervention (T1) to 24 months follow-up (T5)

Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
Periodo de tiempo: From post-intervention (T1) to 12 months follow-up (T4)

Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
Periodo de tiempo: From post-intervention (T1) to 24 months follow-up (T5)

Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Peak oxygen uptake (VO2peak) is measured
From baseline (T0) to 12 weeks (T1)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Peak oxygen uptake (VO2peak) is measured
From baseline (T0) to 24 weeks (T2)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Peak oxygen uptake (VO2peak) is measured
From baseline (T0) to 36 weeks (T3)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.
From baseline (T0) to 12 weeks (T1)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.
From baseline (T0) to 24 weeks (T2)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.
From baseline (T0) to 36 weeks (T3)
Difference in change in lower body muscle strength between groups assessed by leg press
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.
From baseline (T0) to 12 weeks (T1)
Difference in change in lower body muscle strength between groups assessed by leg press
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.
From baseline (T0) to 24 weeks (T2)
Difference in change in lower body muscle strength between groups assessed by leg press
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.
From baseline (T0) to 36 weeks (T3)
Difference in change in lower body muscle strength between groups assessed by push-ups
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The maximum number of push-ups that can be performed in one set
From baseline (T0) to 12 weeks (T1)
Difference in change in upper body muscle strength between groups assessed by push-ups
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The maximum number of push-ups that can be performed in one set
From baseline (T0) to 24 weeks (T2)
Difference in change in upper body muscle strength between groups assessed by push-ups
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The maximum number of push-ups that can be performed in one set
From baseline (T0) to 36 weeks (T3)
Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
From baseline (T0) to 12 weeks (T1)
Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
From baseline (T0) to 24 weeks (T2)
Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
From baseline (T0) to 36 weeks (T3)
Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9
Periodo de tiempo: From post-intervention (T1) to 12-month follow-up (T4)

Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
From post-intervention (T1) to 12-month follow-up (T4)
Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9
Periodo de tiempo: From post-intervention (T1) to 24-month follow-up (T5)

Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
From baseline (T0) to 12 weeks (T1)
Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

Each item is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
From baseline (T0) to 24 weeks (T2)
Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
From baseline (T0) to 36 weeks (T3)
Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).
Periodo de tiempo: From baseline (T0) to 12 months follow-up weeks (T4)

Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
From baseline (T0) to 12 months follow-up weeks (T4)
Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).
Periodo de tiempo: From baseline (T0) to 24 months follow-up weeks (T5)

Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
From baseline (T0) to 24 months follow-up weeks (T5)
Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
From baseline (T0) to 12 weeks (T1)
Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
From baseline (T0) to 24 weeks (T2)
Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
From baseline (T0) to 36 weeks (T3)
Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.
Periodo de tiempo: From post-intervention (T1) to 12 months follow-up (T4)

The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
From post-intervention (T1) to 12 months follow-up (T4)
Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.
Periodo de tiempo: From post-intervention (T1) to 24 months follow-up (T5)

The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.
From baseline (T0) to 12 weeks (T1)
Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.
From baseline (T0) to 24 weeks (T2)
Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.
From baseline (T0) to 36 weeks (T3)
Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.
From baseline (T0) to 12 weeks (T1)
Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.
From baseline (T0) to 24 weeks (T2)
Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.
From baseline (T0) to 36 weeks (T3)
Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.
From baseline (T0) to 12 weeks (T1)
Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.
From baseline (T0) to 24 weeks (T2)
Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.
From baseline (T0) to 36 weeks (T3)
Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain & discomfort, anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension.
From baseline (T0) to 12 weeks (T1)
Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain & discomfort, anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension.
From baseline (T0) to 24 weeks (T2)
Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain & discomfort, anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension.
From baseline (T0) to 36 weeks (T3)
Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
From baseline (T0) to 12 weeks (T1)
Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
From baseline (T0) to 24 weeks (T2)
Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
From baseline (T0) to 36 weeks (T3)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 12 weeks (T1)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 12 weeks (T1)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 24 weeks (T2)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 24 weeks (T2)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 36 weeks (T2)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 36 weeks (T2)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Periodo de tiempo: From baseline (T0) to 36 weeks (T3)

The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
From baseline (T0) to 36 weeks (T3)
Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).
Periodo de tiempo: From baseline (0) to 36 weeks (T3)

Combining information about health-related QoL will give quality-adjusted life-years, while valuation of resource use using standard principles of health economic evaluation will provide estimates of costs
From baseline (0) to 36 weeks (T3)
Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway
Periodo de tiempo: At 12- and 24-month follow-up

Questions assessing benefits of the intervention
At 12- and 24-month follow-up
Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions
Periodo de tiempo: At 12- and 24-month follow-up

Questions assessing daily use of information, strategies and advices learned in the intervention program
At 12- and 24-month follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Oslo University Hospital

Colaboradores

University of Oslo
Norwegian University of Science and Technology
University of Alberta
Diakonhjemmet Hospital
St. Olavs Hospital
Norwegian School of Sport Sciences
UiT The Arctic University of Norway

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de noviembre de 2021

Finalización primaria (Actual)

30 de junio de 2023

Finalización del estudio (Actual)

30 de agosto de 2025

Fechas de registro del estudio

Enviado por primera vez

10 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

10 de noviembre de 2021

Publicado por primera vez (Actual)

22 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • #153665

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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