A Complex Intervention for Chronically Fatigued Lymphoma Survivors

Chronic Fatigue Syndrome Clinical Trial

Official title:

A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05130099
• Other study ID #: #153665
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue Syndrome, Chronic
• Lymphoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (8)

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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire	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)
Secondary	Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire	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)
Secondary	Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire	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)
Secondary	Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire	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)
Secondary	Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	Difference in change in work status between groups assessed by questions from the HUNT4-study	Participants are asked to report their current work status	From baseline (T0) to 12 weeks (T1)
Secondary	Difference in change in work status between groups assessed by questions from the HUNT4-study	Participants are asked to report their current work status	From baseline (T0) to 24 weeks (T2)
Secondary	Difference in change in work status between groups assessed by questions from the HUNT4-study	Participants are asked to report their current work status	From baseline (T0) to 36 weeks (T3)
Secondary	Change in work status in both groups assessed by questions from the HUNT4-study	Participants are asked to report their current work status	From post-intervention (T1) to 12 months follow-up (T4)
Secondary	Change in work status in both groups assessed by questions from the HUNT4-study	Participants are asked to report their current work status	From post-intervention (T1) to 24 months follow-up (T5)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index scale	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index scale	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index scale	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)
Secondary	Change in work ability in both groups assessed by the Work Ability Index scale	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)
Secondary	Change in work ability in both groups assessed by the Work Ability Index scale	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job	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)
Secondary	Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job	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)
Secondary	Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job	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)
Secondary	Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job	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)
Secondary	Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job	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)
Secondary	Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job	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)
Secondary	Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)	Peak oxygen uptake (VO2peak) is measured	From baseline (T0) to 12 weeks (T1)
Secondary	Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)	Peak oxygen uptake (VO2peak) is measured	From baseline (T0) to 24 weeks (T2)
Secondary	Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)	Peak oxygen uptake (VO2peak) is measured	From baseline (T0) to 36 weeks (T3)
Secondary	Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test	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)
Secondary	Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test	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)
Secondary	Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test	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)
Secondary	Difference in change in lower body muscle strength between groups assessed by leg press	The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.	From baseline (T0) to 12 weeks (T1)
Secondary	Difference in change in lower body muscle strength between groups assessed by leg press	The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.	From baseline (T0) to 24 weeks (T2)
Secondary	Difference in change in lower body muscle strength between groups assessed by leg press	The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.	From baseline (T0) to 36 weeks (T3)
Secondary	Difference in change in lower body muscle strength between groups assessed by push-ups	The maximum number of push-ups that can be performed in one set	From baseline (T0) to 12 weeks (T1)
Secondary	Difference in change in upper body muscle strength between groups assessed by push-ups	The maximum number of push-ups that can be performed in one set	From baseline (T0) to 24 weeks (T2)
Secondary	Difference in change in upper body muscle strength between groups assessed by push-ups	The maximum number of push-ups that can be performed in one set	From baseline (T0) to 36 weeks (T3)
Secondary	Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9	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)
Secondary	Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9	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)
Secondary	Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9	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)
Secondary	Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9	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)
Secondary	Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9	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)
Secondary	Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).	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)
Secondary	Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).	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)
Secondary	Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).	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)
Secondary	Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).	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)
Secondary	Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).	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)
Secondary	Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.	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)
Secondary	Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.	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)
Secondary	Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.	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)
Secondary	Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.	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)
Secondary	Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.	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)
Secondary	Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.	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)
Secondary	Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.	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)
Secondary	Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.	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)
Secondary	Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale	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)
Secondary	Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale	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)
Secondary	Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale	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)
Secondary	Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ	DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.	From baseline (T0) to 12 weeks (T1)
Secondary	Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ	DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.	From baseline (T0) to 24 weeks (T2)
Secondary	Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ	DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.	From baseline (T0) to 36 weeks (T3)
Secondary	Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)	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)
Secondary	Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)	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)
Secondary	Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)	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)
Secondary	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)	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)
Secondary	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)	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)
Secondary	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)	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	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).	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)
Secondary	Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).	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)
Secondary	Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway	Questions assessing benefits of the intervention	At 12- and 24-month follow-up
Secondary	Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions	Questions assessing daily use of information, strategies and advices learned in the intervention program	At 12- and 24-month follow-up