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A Feasibility Study in Chronically Fatigued Cancer Survivors

20 de abril de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Actual)

15

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Oslo, Noruega, 0379
        • Oslo University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

19 años a 67 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 4
Assessed by structured conversations with the participants
Week 4
Strengths and weaknesses with the inclusion procedure: study personnel
Periodo de tiempo: Week 4
Assessed by structured conversations with the study personnel
Week 4
Feasibility of the patient education session: participants
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 13
Registered by the physiotherapists in an exercise log
Week 13
Compliance to the exercise program: intensity during the aerobic exercise intervals
Periodo de tiempo: Week 13
Registered by pulse sensors
Week 13
Compliance to the exercise program: implementation of the strength training exercises
Periodo de tiempo: Week 13
Registered by the physiotherapists in an exercise log
Week 13
Feasibility of the exercise program part three (week 8-12): participants
Periodo de tiempo: 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
Periodo de tiempo: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Week 13
Feasibility of the questionnaires
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 13
Assessed by the completion rate of the questionnaire (i.e. proportion of missing).
Week 13

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in level of fatigue
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de abril de 2021

Finalización primaria (Actual)

31 de enero de 2022

Finalización del estudio (Actual)

31 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2021

Publicado por primera vez (Actual)

18 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

20 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 153665

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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