A Complex Intervention for Chronically Fatigued Lymphoma Survivors

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Other: Interdisciplinary complex intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interdisciplinary complex 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lymphoma; physical activity; nutrition; patient education; cancer survivorship; cognitive behavioral program
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Chronic Disease; Neuroinflammatory Diseases; Lymphoma; Fatigue Syndrome, Chronic
• Other Study ID Numbers: #153665

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No