Clinical trial NCT05130099: A Complex Intervention for Chronically Fatigued Lymphoma Survivors
Official title: A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: lymphoma
cancer survivorship
physical activity
nutrition
patient education
cognitive behavioral program
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian School of Sport Sciences
name: UiT The Arctic University of Norway
name: Norwegian University of Science and Technology
name: Diakonhjemmet Hospital
name: University of Alberta
name: St. Olavs Hospital
First posted: 2021-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
timeFrame: From baseline (T0) to 12 weeks (T1)
Secondary outcomes:
measure: Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
timeFrame: From post-intervention (T1) to 12-month follow-up (T4)
measure: Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
timeFrame: From post-intervention (T1) to 24-month follow-up (T5)
measure: 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).
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: 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).
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: 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).
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: 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).
timeFrame: From post-intervention (T1) to 12-month follow-up (T4)
measure: 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).
timeFrame: From post-intervention (T1) to 24-month follow-up (T5)
measure: 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).
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: 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).
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: 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).
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: 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).
timeFrame: From post-intervention (T1) to 12-month follow-up (T4)
measure: 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).
timeFrame: From post-intervention (T1) to 24-month follow-up (T5)
measure: Difference in change in work status between groups assessed by questions from the HUNT4-study
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in work status between groups assessed by questions from the HUNT4-study
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in work status between groups assessed by questions from the HUNT4-study
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in work status in both groups assessed by questions from the HUNT4-study
timeFrame: From post-intervention (T1) to 12 months follow-up (T4)
measure: Change in work status in both groups assessed by questions from the HUNT4-study
timeFrame: From post-intervention (T1) to 24 months follow-up (T5)
measure: Difference in change in work ability between groups assessed by the Work Ability Index scale
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in work ability between groups assessed by the Work Ability Index scale
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in work ability between groups assessed by the Work Ability Index scale
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in work ability in both groups assessed by the Work Ability Index scale
timeFrame: From post-intervention (T1) to 12 months follow-up (T4)
measure: Change in work ability in both groups assessed by the Work Ability Index scale
timeFrame: From post-intervention (T1) to 24 months follow-up (T5)
measure: Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
timeFrame: From post-intervention (T1) to 12 months follow-up (T4)
measure: Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
timeFrame: From post-intervention (T1) to 24 months follow-up (T5)
measure: Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
timeFrame: From post-intervention (T1) to 12 months follow-up (T4)
measure: Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
timeFrame: From post-intervention (T1) to 24 months follow-up (T5)
measure: Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in lower body muscle strength between groups assessed by leg press
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in lower body muscle strength between groups assessed by leg press
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in lower body muscle strength between groups assessed by leg press
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in lower body muscle strength between groups assessed by push-ups
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in upper body muscle strength between groups assessed by push-ups
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in upper body muscle strength between groups assessed by push-ups
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9
timeFrame: From post-intervention (T1) to 12-month follow-up (T4)
measure: Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9
timeFrame: From post-intervention (T1) to 24-month follow-up (T5)
measure: Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).
timeFrame: From baseline (T0) to 12 months follow-up weeks (T4)
measure: Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).
timeFrame: From baseline (T0) to 24 months follow-up weeks (T5)
measure: Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.
timeFrame: From post-intervention (T1) to 12 months follow-up (T4)
measure: Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.
timeFrame: From post-intervention (T1) to 24 months follow-up (T5)
measure: Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: 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)
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: 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)
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: 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)
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: 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).
timeFrame: From baseline (T0) to 12 weeks (T1)
measure: 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).
timeFrame: From baseline (T0) to 24 weeks (T2)
measure: 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).
timeFrame: From baseline (T0) to 36 weeks (T2)
measure: 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).
timeFrame: From baseline (T0) to 36 weeks (T3)
measure: Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).
timeFrame: From baseline (0) to 36 weeks (T3)
measure: Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway
timeFrame: At 12- and 24-month follow-up
measure: Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions
timeFrame: At 12- and 24-month follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: