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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
The intervention will last for 12 weeks and includes four components; patient education, physical exercise, cognitive behavioral program and nutritional counseling. The patient education will include an online 2-hours group-based patient-education sessions in week 1. The physical exercise program includes two weekly exercise sessions, one supervised by a physiotherapist and one unsupervised, including aerobic exercise, resistance exercise and psychometric physiotherapy. Half of the intervention group (N=7) will perform the supervised exercise session individually with a physiotherapist in the municipality, while the other half (n=8) will exercise in online groups lead by physiotherapists. The cognitive behavioral program will begin in week 3 and include six group-based online sessions every week lead by a clinical psychologist. The nutritional counseling will include three individual digital nutrition counselling sessions in week 2, 6 and 10 by a clinical dietitian.
Oslo University Hospital
Oslo, Norway
Recruitment rate
Assessed by the number who consent to participate
Time frame: The week before the intervention period (week 0)
Inclusion rate
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).
Time frame: The week before the intervention period (week 0)
Completion rate
Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment
Time frame: The week before the intervention period (week 0)
Strengths and weaknesses with the inclusion procedure: participants
Assessed by structured conversations with the participants
Time frame: Week 4
Strengths and weaknesses with the inclusion procedure: study personnel
Assessed by structured conversations with the study personnel
Time frame: Week 4
Feasibility of the patient education session: participants
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.
Time frame: Week 4
Feasibility of the patient education session: presenters
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.
Time frame: Week 4
Feasibility of the exercise program part one (week 1-3): participants
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Time frame: Week 4
Feasibility of the exercise program part one (week 1-3): physiotherapists
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Time frame: Week 4
Feasibility of the exercise program part two (week 4-7): participants
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Time frame: Week 8
Feasibility of the exercise program part two (week 4-7): physiotherapists
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Time frame: Week 8
Compliance to the cognitive behavioral therapy groups sessions
Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..
Time frame: Week 8
Feasibility of the cognitive behavioral therapy groups sessions: participants
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session
Time frame: Week 8
Feasibility of the cognitive behavioral therapy groups sessions: psychologists
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session
Time frame: Week 8
Compliance to the nutrition counseling
Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.
Time frame: Week 11
Feasibility of the nutrition counseling: participants
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the participants after the last counseling session.
Time frame: Week 11
Feasibility of the nutrition counseling: clinical dietitian
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.
Time frame: Week 11
Compliance to the exercise program: attendance
Registered by the physiotherapists in an exercise log
Time frame: Week 13
Compliance to the exercise program: intensity during the aerobic exercise intervals
Registered by pulse sensors
Time frame: Week 13
Compliance to the exercise program: implementation of the strength training exercises
Registered by the physiotherapists in an exercise log
Time frame: Week 13
Feasibility of the exercise program part three (week 8-12): participants
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Time frame: Week 13
Feasibility of the exercise program part three (week 8-12): physiotherapists
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Time frame: Week 13
Feasibility of the questionnaires
Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.
Time frame: Week 13
Feasibility of the physical tests: participants
Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.
Time frame: Week 13
Feasibility of the physical tests: physiotherapists
Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.
Time frame: Week 13
Compliance to the physical tests
Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).
Time frame: Week 13
Completeness of the questionnaires
Assessed by the completion rate of the questionnaire (i.e. proportion of missing).
Time frame: Week 13
Change in level of fatigue
Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in level of fatigue
Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of fatigue
Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in daily functioning and global quality of life
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in daily functioning and global quality of life
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in daily functioning and global quality of life
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
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Change in subjective well-being
Measured by the Satisfaction with Life Scale. Total score range from 5 to 35, with increasing score implying higher subjective well-being.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in vitality
Measured by the Subjective Vitality Scale. The total score ranges from 6 to 36 with a higher score indicating a better condition
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in general health
Measured by European Quality of Life Five-dimension Scale Questionnaire (EQ-5D). Total score range from 5 (worst health) to 25 (best health).
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in work ability
Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in anxiety symptoms
Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in anxiety symptoms
Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in anxiety symptoms
Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in depressive symptoms
Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in depressive symptoms
Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in depressive symptoms
Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in level of physical activity
Measured by the Godin Leisure Time Exercise Questionnaire
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in level of physical activity
Measured by the Godin Leisure Time Exercise Questionnaire
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of physical activity
Measured by the Godin Leisure Time Exercise Questionnaire
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in exercise mastery
Assessed by the Perceived Competence Scale. The scale consists of 4 items (statements). On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in exercise mastery
Assessed by the Perceived Competence Scale. The scale consists of 4 items (statements). On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in exercise mastery
Assessed by the Perceived Competence Scale. The scale consists of 4 items (statements). On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in dietary intake of the participants
Measured by a digital food frequency questionnaire (DIGIKOST-FFQ)
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in meal pattern
Measured by the Meal Pattern Questionnaire
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
Calculated by measuring weight and height
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
Calculated by measuring weight and height
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in body mass index
Calculated by measuring weight and height
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in sleep problems
Measured by questions from the Trøndelag Health Survey
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in sleep problems
Measured by questions from the Trøndelag Health Survey
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in sleep problems
Measured by questions from the Trøndelag Health Survey
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in cardiorespiratory fitness
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in cardiorespiratory fitness
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in cardiorespiratory fitness
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in lower body muscle strength
Assessed by 30 second sit-to-stand test
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in lower body muscle strength
Assessed by 30 second sit-to-stand test
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in lower body muscle strength
Assessed by 30 second sit-to-stand test
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in upper body muscle strength
Assessed by maximum repetitions of push-ups with various starting positions
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in upper body muscle strength
Assessed by maximum repetitions of push-ups with various starting positions
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in upper body muscle strength
Assessed by maximum repetitions of push-ups with various starting positions
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in quality of life among relatives
Assessed by the Research and Development 36-item Short Form Survey (RAND SF-36).The eight scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in global health status among relatives
The global health status / quality of life scale from the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range from 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Time frame: Change from baseline (week 0) and to post-intervention (week 13)