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A Feasibility Study in Chronically Fatigued Cancer Survivors

2022년 4월 20일 업데이트: Lene Thorsen, Oslo University Hospital

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.

연구 개요

연구 유형

중재적

등록 (실제)

15

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Oslo, 노르웨이, 0379
        • Oslo University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

19년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Interdisciplinary complex intervention
The intervention includes patient education, physical exercise, a group-based cognitive behavioral program and individual nutritional counseling

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment rate
기간: The week before the intervention period (week 0)
Assessed by the number who consent to participate
The week before the intervention period (week 0)
Inclusion rate
기간: 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).
The week before the intervention period (week 0)
Completion rate
기간: 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
The week before the intervention period (week 0)
Strengths and weaknesses with the inclusion procedure: participants
기간: Week 4
Assessed by structured conversations with the participants
Week 4
Strengths and weaknesses with the inclusion procedure: study personnel
기간: Week 4
Assessed by structured conversations with the study personnel
Week 4
Feasibility of the patient education session: participants
기간: 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.
Week 4
Feasibility of the patient education session: presenters
기간: 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.
Week 4
Feasibility of the exercise program part one (week 1-3): participants
기간: Week 4
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Week 4
Feasibility of the exercise program part one (week 1-3): physiotherapists
기간: Week 4
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Week 4
Feasibility of the exercise program part two (week 4-7): participants
기간: Week 8
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Week 8
Feasibility of the exercise program part two (week 4-7): physiotherapists
기간: Week 8
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Week 8
Compliance to the cognitive behavioral therapy groups sessions
기간: Week 8
Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..
Week 8
Feasibility of the cognitive behavioral therapy groups sessions: participants
기간: Week 8
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session
Week 8
Feasibility of the cognitive behavioral therapy groups sessions: psychologists
기간: Week 8
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session
Week 8
Compliance to the nutrition counseling
기간: Week 11
Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.
Week 11
Feasibility of the nutrition counseling: participants
기간: 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.
Week 11
Feasibility of the nutrition counseling: clinical dietitian
기간: 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.
Week 11
Compliance to the exercise program: attendance
기간: Week 13
Registered by the physiotherapists in an exercise log
Week 13
Compliance to the exercise program: intensity during the aerobic exercise intervals
기간: Week 13
Registered by pulse sensors
Week 13
Compliance to the exercise program: implementation of the strength training exercises
기간: Week 13
Registered by the physiotherapists in an exercise log
Week 13
Feasibility of the exercise program part three (week 8-12): participants
기간: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Week 13
Feasibility of the exercise program part three (week 8-12): physiotherapists
기간: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Week 13
Feasibility of the questionnaires
기간: Week 13
Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.
Week 13
Feasibility of the physical tests: participants
기간: Week 13
Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.
Week 13
Feasibility of the physical tests: physiotherapists
기간: Week 13
Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.
Week 13
Compliance to the physical tests
기간: Week 13
Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).
Week 13
Completeness of the questionnaires
기간: Week 13
Assessed by the completion rate of the questionnaire (i.e. proportion of missing).
Week 13

2차 결과 측정

결과 측정
측정값 설명
기간
Change in level of fatigue
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in level of fatigue
기간: 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.
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of fatigue
기간: 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.
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in daily functioning and global quality of life
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in daily functioning and global quality of life
기간: 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.
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in daily functioning and global quality of life
기간: 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.
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in subjective well-being
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in vitality
기간: 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
Change from baseline (week 0) and to post-intervention (week 13)
Change in general health
기간: 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).
Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
기간: 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.
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in work ability
기간: 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.
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in anxiety symptoms
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in anxiety symptoms
기간: 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.
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in anxiety symptoms
기간: 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.
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in depressive symptoms
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in depressive symptoms
기간: 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.
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in depressive symptoms
기간: 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.
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in level of physical activity
기간: Change from baseline (week 0) and to post-intervention (week 13)
Measured by the Godin Leisure Time Exercise Questionnaire
Change from baseline (week 0) and to post-intervention (week 13)
Change in level of physical activity
기간: Change from baseline (week 0) to 4 months follow-up (week 29)
Measured by the Godin Leisure Time Exercise Questionnaire
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of physical activity
기간: Change from baseline (week 0) to 7 months follow-up (week 42)
Measured by the Godin Leisure Time Exercise Questionnaire
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in exercise mastery
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in exercise mastery
기간: 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.
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in exercise mastery
기간: 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.
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in dietary intake of the participants
기간: Change from baseline (week 0) and to post-intervention (week 13)
Measured by a digital food frequency questionnaire (DIGIKOST-FFQ)
Change from baseline (week 0) and to post-intervention (week 13)
Change in meal pattern
기간: Change from baseline (week 0) and to post-intervention (week 13)
Measured by the Meal Pattern Questionnaire
Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
기간: Change from baseline (week 0) and to post-intervention (week 13)
Calculated by measuring weight and height
Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
기간: Change from baseline (week 0) to 4 months follow-up (week 29)
Calculated by measuring weight and height
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in body mass index
기간: Change from baseline (week 0) to 7 months follow-up (week 42)
Calculated by measuring weight and height
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in sleep problems
기간: Change from baseline (week 0) and to post-intervention (week 13)
Measured by questions from the Trøndelag Health Survey
Change from baseline (week 0) and to post-intervention (week 13)
Change in sleep problems
기간: Change from baseline (week 0) to 4 months follow-up (week 29)
Measured by questions from the Trøndelag Health Survey
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in sleep problems
기간: Change from baseline (week 0) to 7 months follow-up (week 42)
Measured by questions from the Trøndelag Health Survey
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in cardiorespiratory fitness
기간: Change from baseline (week 0) and to post-intervention (week 13)
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Change from baseline (week 0) and to post-intervention (week 13)
Change in cardiorespiratory fitness
기간: Change from baseline (week 0) to 4 months follow-up (week 29)
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in cardiorespiratory fitness
기간: Change from baseline (week 0) to 7 months follow-up (week 42)
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in lower body muscle strength
기간: Change from baseline (week 0) and to post-intervention (week 13)
Assessed by 30 second sit-to-stand test
Change from baseline (week 0) and to post-intervention (week 13)
Change in lower body muscle strength
기간: Change from baseline (week 0) to 4 months follow-up (week 29)
Assessed by 30 second sit-to-stand test
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in lower body muscle strength
기간: Change from baseline (week 0) to 7 months follow-up (week 42)
Assessed by 30 second sit-to-stand test
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in upper body muscle strength
기간: Change from baseline (week 0) and to post-intervention (week 13)
Assessed by maximum repetitions of push-ups with various starting positions
Change from baseline (week 0) and to post-intervention (week 13)
Change in upper body muscle strength
기간: Change from baseline (week 0) to 4 months follow-up (week 29)
Assessed by maximum repetitions of push-ups with various starting positions
Change from baseline (week 0) to 4 months follow-up (week 29)
Change in upper body muscle strength
기간: Change from baseline (week 0) to 7 months follow-up (week 42)
Assessed by maximum repetitions of push-ups with various starting positions
Change from baseline (week 0) to 7 months follow-up (week 42)
Change in quality of life among relatives
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)
Change in global health status among relatives
기간: 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.
Change from baseline (week 0) and to post-intervention (week 13)

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 4월 6일

기본 완료 (실제)

2022년 1월 31일

연구 완료 (실제)

2022년 1월 31일

연구 등록 날짜

최초 제출

2021년 4월 16일

QC 기준을 충족하는 최초 제출

2021년 6월 17일

처음 게시됨 (실제)

2021년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 20일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 153665

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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