Clinical trial NCT04931407: A Feasibility Study in Chronically Fatigued Cancer Survivors
Official title: A Feasibility Study in Chronically Fatigued Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lymphoma
Keywords: exercise
chronic fatigue
lymphoma
cancer survivors
nutrition
cognitive therapy
patient education
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Diakonhjemmet Hospital
name: Norwegian School of Sport Sciences
name: Norwegian University of Science and Technology
name: University of Alberta
name: UiT The Arctic University of Norway
First posted: 2021-06-18
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect their QoL. Well-documented late-effects among cancer survivors are second cancer, cardio-vascular disease, pain, hormone disturbances, mental distress and chronic fatigue (CF).

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.

CF is a complex condition best understood as a multifactorial phenomenon. Our and other research groups have examined various cohorts of cancer survivors in order to identify behavioral-, psychological-, and biological factors associated with CF, that can form the basis for targeted interventions. So far, few treatable biological factors have been identified, even though immune activation, flattened diurnal cortisol slopes and a blunted cortisol response to stress have been demonstrated in small studies among cancer survivors suffering from CF. On the other hand, 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 Division of Cancer Medicine at Oslo University Hospital (OUH) presently offers limited rehabilitation programs, including patient education, physical exercise, cognitive behavioral program and nutrition counselling to cancer survivors with CF. However, these programs are not offered as an interdisciplinary intervention integrated in a standardized patient care pathway, and the effects of these interventions have not been assessed. Based on the investigators clinical experience and published studies on single-targeted interventions, the investigators hypothesize that a complex intervention including psycho-educational elements, physical exercise and nutrition counseling delivered as a standardized patient care pathway is well-founded and doable, and will improve fatigue, functioning and QoL in cancer survivors with CF.

During the fall of 2021, the investigators will conduct a randomized controlled trial (RCT) with the overall objective to improve fatigue in lymphoma survivors with CF. To uncover strengths and weaknesses with the planned RCT, i.e. the inclusion procedures, the assessments and the complex intervention, the investigators are now conducting a small one-armed feasibility study before the RCT during spring 2021.


Eligibility criteria: Seven lymphoma survivors will be included, with the same inclusion criteria as in the planned RCT:

Inclusion Criteria:

* Survivors of Hodgkin and aggressive non-Hodgkin lymphoma, diagnosed 2014 or 2019 (n=7)
* 18-65 years at diagnosis, and 19-67 years at participation.
* CF measured by Chalder FQ.
* Curatively treated, more than 2 years since last treatment.
* Participation approval from oncologist.

Exclusion Criteria:

* Indolent non-Hodgkin lymphoma.
* Fatigue more than one year before the cancer diagnosis.
* Ongoing cancer treatment, relapse or second cancer, somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches).
* Psychiatric disorders (i.e. severe depression, schizophrenia), substance abuse disorder.

In addition, eight cancer survivors with various diagnosis, will be included from a waiting list for rehabilitation at the Cancer Rehabilitation Centre at Aker hospital.

Primary outcomes:
measure: Recruitment rate
timeFrame: The week before the intervention period (week 0)
measure: Inclusion rate
timeFrame: The week before the intervention period (week 0)
measure: Completion rate
timeFrame: The week before the intervention period (week 0)
measure: Strengths and weaknesses with the inclusion procedure: participants
timeFrame: Week 4
measure: Strengths and weaknesses with the inclusion procedure: study personnel
timeFrame: Week 4
measure: Feasibility of the patient education session: participants
timeFrame: Week 4
measure: Feasibility of the patient education session: presenters
timeFrame: Week 4
measure: Feasibility of the exercise program part one (week 1-3): participants
timeFrame: Week 4
measure: Feasibility of the exercise program part one (week 1-3): physiotherapists
timeFrame: Week 4
measure: Feasibility of the exercise program part two (week 4-7): participants
timeFrame: Week 8
measure: Feasibility of the exercise program part two (week 4-7): physiotherapists
timeFrame: Week 8
measure: Compliance to the cognitive behavioral therapy groups sessions
timeFrame: Week 8
measure: Feasibility of the cognitive behavioral therapy groups sessions: participants
timeFrame: Week 8
measure: Feasibility of the cognitive behavioral therapy groups sessions: psychologists
timeFrame: Week 8
measure: Compliance to the nutrition counseling
timeFrame: Week 11
measure: Feasibility of the nutrition counseling: participants
timeFrame: Week 11
measure: Feasibility of the nutrition counseling: clinical dietitian
timeFrame: Week 11
measure: Compliance to the exercise program: attendance
timeFrame: Week 13
measure: Compliance to the exercise program: intensity during the aerobic exercise intervals
timeFrame: Week 13
measure: Compliance to the exercise program: implementation of the strength training exercises
timeFrame: Week 13
measure: Feasibility of the exercise program part three (week 8-12): participants
timeFrame: Week 13
measure: Feasibility of the exercise program part three (week 8-12): physiotherapists
timeFrame: Week 13
measure: Feasibility of the questionnaires
timeFrame: Week 13
measure: Feasibility of the physical tests: participants
timeFrame: Week 13
measure: Feasibility of the physical tests: physiotherapists
timeFrame: Week 13
measure: Compliance to the physical tests
timeFrame: Week 13
measure: Completeness of the questionnaires
timeFrame: Week 13
Secondary outcomes:
measure: Change in level of fatigue
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in level of fatigue
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in level of fatigue
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in daily functioning and global quality of life
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in daily functioning and global quality of life
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in daily functioning and global quality of life
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in subjective well-being
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in vitality
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in general health
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in work ability
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in work ability
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in work ability
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in anxiety symptoms
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in anxiety symptoms
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in anxiety symptoms
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in depressive symptoms
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in depressive symptoms
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in depressive symptoms
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in level of physical activity
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in level of physical activity
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in level of physical activity
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in exercise mastery
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in exercise mastery
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in exercise mastery
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in dietary intake of the participants
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in meal pattern
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in body mass index
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in body mass index
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in body mass index
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in sleep problems
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in sleep problems
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in sleep problems
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in cardiorespiratory fitness
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in cardiorespiratory fitness
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in cardiorespiratory fitness
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in lower body muscle strength
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in lower body muscle strength
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in lower body muscle strength
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in upper body muscle strength
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in upper body muscle strength
timeFrame: Change from baseline (week 0) to 4 months follow-up (week 29)
measure: Change in upper body muscle strength
timeFrame: Change from baseline (week 0) to 7 months follow-up (week 42)
measure: Change in quality of life among relatives
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
measure: Change in global health status among relatives
timeFrame: Change from baseline (week 0) and to post-intervention (week 13)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lene Thorsen
role: PRINCIPAL_INVESTIGATOR
References: