A Feasibility Study in Chronically Fatigued Cancer Survivors

Lymphoma Clinical Trial

Official title:

A Feasibility Study in Chronically Fatigued Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931407
• Other study ID #: 153665
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Lymphoma

Intervention

Other:
• A 12-week interdisciplinary complex intervention
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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (7)

Lead Sponsor	Collaborator
Oslo University Hospital	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Assessed by the number who consent to participate	The week before the intervention period (week 0)
Primary	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).	The week before the intervention period (week 0)
Primary	Completion rate	Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment	The week before the intervention period (week 0)
Primary	Strengths and weaknesses with the inclusion procedure: participants	Assessed by structured conversations with the participants	Week 4
Primary	Strengths and weaknesses with the inclusion procedure: study personnel	Assessed by structured conversations with the study personnel	Week 4
Primary	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.	Week 4
Primary	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.	Week 4
Primary	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	Week 4
Primary	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	Week 4
Primary	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	Week 8
Primary	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	Week 8
Primary	Compliance to the cognitive behavioral therapy groups sessions	Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..	Week 8
Primary	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	Week 8
Primary	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	Week 8
Primary	Compliance to the nutrition counseling	Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.	Week 11
Primary	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.	Week 11
Primary	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.	Week 11
Primary	Compliance to the exercise program: attendance	Registered by the physiotherapists in an exercise log	Week 13
Primary	Compliance to the exercise program: intensity during the aerobic exercise intervals	Registered by pulse sensors	Week 13
Primary	Compliance to the exercise program: implementation of the strength training exercises	Registered by the physiotherapists in an exercise log	Week 13
Primary	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	Week 13
Primary	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	Week 13
Primary	Feasibility of the questionnaires	Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.	Week 13
Primary	Feasibility of the physical tests: participants	Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.	Week 13
Primary	Feasibility of the physical tests: physiotherapists	Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.	Week 13
Primary	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).	Week 13
Primary	Completeness of the questionnaires	Assessed by the completion rate of the questionnaire (i.e. proportion of missing).	Week 13
Secondary	Change in level of fatigue	Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in level of fatigue	Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in level of fatigue	Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	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.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	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.	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	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.	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	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.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	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	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	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).	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in work ability	Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in work ability	Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in work ability	Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	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.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	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.	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	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.	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in depressive symptoms	Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in depressive symptoms	Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in depressive symptoms	Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in level of physical activity	Measured by the Godin Leisure Time Exercise Questionnaire	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in level of physical activity	Measured by the Godin Leisure Time Exercise Questionnaire	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in level of physical activity	Measured by the Godin Leisure Time Exercise Questionnaire	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	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.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	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.	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	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.	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in dietary intake of the participants	Measured by a digital food frequency questionnaire (DIGIKOST-FFQ)	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in meal pattern	Measured by the Meal Pattern Questionnaire	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in body mass index	Calculated by measuring weight and height	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in body mass index	Calculated by measuring weight and height	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in body mass index	Calculated by measuring weight and height	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in sleep problems	Measured by questions from the Trøndelag Health Survey	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in sleep problems	Measured by questions from the Trøndelag Health Survey	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in sleep problems	Measured by questions from the Trøndelag Health Survey	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in cardiorespiratory fitness	Assessed by a submaximal and indirect treadmill test (modified Balke protocol)	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in cardiorespiratory fitness	Assessed by a submaximal and indirect treadmill test (modified Balke protocol)	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in cardiorespiratory fitness	Assessed by a submaximal and indirect treadmill test (modified Balke protocol)	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in lower body muscle strength	Assessed by 30 second sit-to-stand test	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in lower body muscle strength	Assessed by 30 second sit-to-stand test	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in lower body muscle strength	Assessed by 30 second sit-to-stand test	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	Change in upper body muscle strength	Assessed by maximum repetitions of push-ups with various starting positions	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	Change in upper body muscle strength	Assessed by maximum repetitions of push-ups with various starting positions	Change from baseline (week 0) to 4 months follow-up (week 29)
Secondary	Change in upper body muscle strength	Assessed by maximum repetitions of push-ups with various starting positions	Change from baseline (week 0) to 7 months follow-up (week 42)
Secondary	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.	Change from baseline (week 0) and to post-intervention (week 13)
Secondary	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.	Change from baseline (week 0) and to post-intervention (week 13)