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Une intervention complexe pour les survivants du lymphome chroniquement fatigués

2 novembre 2026 mis à jour par: Lene Thorsen, Oslo University Hospital

Une intervention complexe pour un symptôme complexe - un essai contrôlé randomisé chez des survivants d'un lymphome chroniquement fatigué

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Norvège
      • Oslo, Norvège
        • Oslo University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention complexe interdisciplinaire
Autre: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
Délai: 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
Délai: 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
Délai: 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
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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).
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Oslo University Hospital

Collaborateurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 novembre 2021

Achèvement primaire (Réel)

30 juin 2023

Achèvement de l'étude (Réel)

30 août 2025

Dates d'inscription aux études

Première soumission

10 novembre 2021

Première soumission répondant aux critères de contrôle qualité

10 novembre 2021

Première publication (Réel)

22 novembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • #153665

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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