A Feasibility Study in Chronically Fatigued Cancer Survivors
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oslo University Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Recruitment rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: The week before the intervention period (week 0)
Assessed by the number who consent to participate
Strengths and weaknesses with the inclusion procedure: study personnel
Time Frame: Week 4
Assessed by structured conversations with the study personnel
Feasibility of the exercise program part two (week 4-7): physiotherapists
Time Frame: Week 8
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Compliance to the cognitive behavioral therapy groups sessions
Time Frame: Week 8
Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..
Feasibility of the cognitive behavioral therapy groups sessions: participants
Time Frame: Week 8
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session
Feasibility of the cognitive behavioral therapy groups sessions: psychologists
Time Frame: Week 8
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session
Compliance to the nutrition counseling
Time Frame: Week 11
Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.
Feasibility of the nutrition counseling: clinical dietitian
Time Frame: Week 11
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the clinical dietitian after the last counseling session.
Compliance to the exercise program: intensity during the aerobic exercise intervals
Time Frame: Week 13
Registered by pulse sensors
Feasibility of the patient education session: participants
Time Frame: Week 4
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the participants after the patient education session.
Feasibility of the exercise program part one (week 1-3): physiotherapists
Time Frame: Week 4
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Compliance to the exercise program: attendance
Time Frame: Week 13
Registered by the physiotherapists in an exercise log
Compliance to the physical tests
Time Frame: Week 13
Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).
Inclusion rate
Time Frame: The week before the intervention period (week 0)
Assessed by the number of consenting participants who are included (i.e. have chronic fatigue according to the Fatigue Questionnaire, and are cleared for participation by oncologist after the medical screening).
Feasibility of the patient education session: presenters
Time Frame: Week 4
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the presenters after the patient education session.
Feasibility of the exercise program part two (week 4-7): participants
Time Frame: Week 8
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Feasibility of the nutrition counseling: participants
Time Frame: Week 11
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the participants after the last counseling session.
Feasibility of the questionnaires
Time Frame: Week 13
Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.
Completion rate
Time Frame: The week before the intervention period (week 0)
Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment
Strengths and weaknesses with the inclusion procedure: participants
Time Frame: Week 4
Assessed by structured conversations with the participants
Feasibility of the exercise program part one (week 1-3): participants
Time Frame: Week 4
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Completeness of the questionnaires
Time Frame: Week 13
Assessed by the completion rate of the questionnaire (i.e. proportion of missing).
Compliance to the exercise program: implementation of the strength training exercises
Time Frame: Week 13
Registered by the physiotherapists in an exercise log
Feasibility of the exercise program part three (week 8-12): participants
Time Frame: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Feasibility of the exercise program part three (week 8-12): physiotherapists
Time Frame: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Feasibility of the physical tests: participants
Time Frame: Week 13
Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.
Feasibility of the physical tests: physiotherapists
Time Frame: Week 13
Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.
Secondary Outcomes
- Change in depressive symptoms(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in level of physical activity(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in subjective well-being(Change from baseline (week 0) and to post-intervention (week 13))
- Change in vitality(Change from baseline (week 0) and to post-intervention (week 13))
- Change in level of fatigue(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in anxiety symptoms(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in dietary intake of the participants(Change from baseline (week 0) and to post-intervention (week 13))
- Change in sleep problems(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in cardiorespiratory fitness(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in lower body muscle strength(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in daily functioning and global quality of life(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in general health(Change from baseline (week 0) and to post-intervention (week 13))
- Change in work ability(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in meal pattern(Change from baseline (week 0) and to post-intervention (week 13))
- Change in body mass index(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in global health status among relatives(Change from baseline (week 0) and to post-intervention (week 13))
- Change in exercise mastery(Change from baseline (week 0) to 7 months follow-up (week 42))
- Change in quality of life among relatives(Change from baseline (week 0) and to post-intervention (week 13))
- Change in upper body muscle strength(Change from baseline (week 0) to 7 months follow-up (week 42))
Investigators
Lene Thorsen
Principal Investigator
Oslo University Hospital