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Uma intervenção complexa para sobreviventes de linfoma com fadiga crônica

2 de novembro de 2026 atualizado por: Lene Thorsen, Oslo University Hospital

Uma intervenção complexa para um sintoma complexo - um ensaio clínico randomizado em sobreviventes de linfoma com fadiga crônica

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Noruega
      • Oslo, Noruega
        • Oslo University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervenção complexa interdisciplinar
Outro: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de novembro de 2021

Conclusão Primária (Real)

30 de junho de 2023

Conclusão do estudo (Real)

30 de agosto de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

10 de novembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de novembro de 2021

Primeira postagem (Real)

22 de novembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • #153665

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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