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NCT Number: NCT04931407

A Feasibility Study in Chronically Fatigued Cancer Survivors

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.

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Key information

Conditions

Fatigue Behavior Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0379, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A 12-week interdisciplinary complex intervention

Other

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.

Primary outcomes

  1. Recruitment rate

    Time frame: The week before the intervention period (week 0)

    Assessed by the number who consent to participate

  2. 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).

  3. 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

  4. Strengths and weaknesses with the inclusion procedure: participants

    Time frame: Week 4

    Assessed by structured conversations with the participants

  5. Strengths and weaknesses with the inclusion procedure: study personnel

    Time frame: Week 4

    Assessed by structured conversations with the study personnel

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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..

  13. 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

  14. 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

  15. Compliance to the nutrition counseling

    Time frame: Week 11

    Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.

  16. 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.

  17. 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.

  18. Compliance to the exercise program: attendance

    Time frame: Week 13

    Registered by the physiotherapists in an exercise log

  19. Compliance to the exercise program: intensity during the aerobic exercise intervals

    Time frame: Week 13

    Registered by pulse sensors

  20. Compliance to the exercise program: implementation of the strength training exercises

    Time frame: Week 13

    Registered by the physiotherapists in an exercise log

  21. 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

  22. 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

  23. Feasibility of the questionnaires

    Time frame: Week 13

    Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.

  24. 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.

  25. 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.

  26. 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).

  27. Completeness of the questionnaires

    Time frame: Week 13

    Assessed by the completion rate of the questionnaire (i.e. proportion of missing).

Secondary outcomes

  1. Change in level of fatigue

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.

  2. Change in level of fatigue

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.

  3. Change in level of fatigue

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.

  4. Change in daily functioning and global quality of life

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    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.

  5. Change in daily functioning and global quality of life

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    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.

  6. Change in daily functioning and global quality of life

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    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.

  7. Change in subjective well-being

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by the Satisfaction with Life Scale. Total score range from 5 to 35, with increasing score implying higher subjective well-being.

  8. Change in vitality

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by the Subjective Vitality Scale. The total score ranges from 6 to 36 with a higher score indicating a better condition

  9. Change in general health

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by European Quality of Life Five-dimension Scale Questionnaire (EQ-5D). Total score range from 5 (worst health) to 25 (best health).

  10. Change in work ability

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.

  11. Change in work ability

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.

  12. Change in work ability

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.

  13. Change in anxiety symptoms

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.

  14. Change in anxiety symptoms

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.

  15. Change in anxiety symptoms

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.

  16. Change in depressive symptoms

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.

  17. Change in depressive symptoms

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.

  18. Change in depressive symptoms

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.

  19. Change in level of physical activity

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by the Godin Leisure Time Exercise Questionnaire

  20. Change in level of physical activity

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Measured by the Godin Leisure Time Exercise Questionnaire

  21. Change in level of physical activity

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Measured by the Godin Leisure Time Exercise Questionnaire

  22. Change in exercise mastery

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    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.

  23. Change in exercise mastery

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    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.

  24. Change in exercise mastery

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    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.

  25. Change in dietary intake of the participants

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by a digital food frequency questionnaire (DIGIKOST-FFQ)

  26. Change in meal pattern

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by the Meal Pattern Questionnaire

  27. Change in body mass index

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Calculated by measuring weight and height

  28. Change in body mass index

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Calculated by measuring weight and height

  29. Change in body mass index

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Calculated by measuring weight and height

  30. Change in sleep problems

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Measured by questions from the Trøndelag Health Survey

  31. Change in sleep problems

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Measured by questions from the Trøndelag Health Survey

  32. Change in sleep problems

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Measured by questions from the Trøndelag Health Survey

  33. Change in cardiorespiratory fitness

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Assessed by a submaximal and indirect treadmill test (modified Balke protocol)

  34. Change in cardiorespiratory fitness

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Assessed by a submaximal and indirect treadmill test (modified Balke protocol)

  35. Change in cardiorespiratory fitness

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Assessed by a submaximal and indirect treadmill test (modified Balke protocol)

  36. Change in lower body muscle strength

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Assessed by 30 second sit-to-stand test

  37. Change in lower body muscle strength

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Assessed by 30 second sit-to-stand test

  38. Change in lower body muscle strength

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Assessed by 30 second sit-to-stand test

  39. Change in upper body muscle strength

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    Assessed by maximum repetitions of push-ups with various starting positions

  40. Change in upper body muscle strength

    Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)

    Assessed by maximum repetitions of push-ups with various starting positions

  41. Change in upper body muscle strength

    Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)

    Assessed by maximum repetitions of push-ups with various starting positions

  42. Change in quality of life among relatives

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    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.

  43. Change in global health status among relatives

    Time frame: Change from baseline (week 0) and to post-intervention (week 13)

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Diakonhjemmet Hospital
  • Norwegian School of Sport Sciences
  • Norwegian University of Science and Technology
  • UiT The Arctic University of Norway
  • University of Alberta
  • University of Oslo

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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