|- candidate number||14252|
|- NTR Number||NTR3812|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jan-2013|
|- Secondary IDs||KUN 2011-5259 Dutch Cancer Society|
|- Public Title||Interventions for fatigued palliative cancer patients.|
|- Scientific Title||Fatigue in palliative care: Are graded exercise and cognitive behaviour therapy effective treatments and what mediates the treatment response?|
|- hypothesis||Fatigue is an important symptom lowering the quality of life in patients with advanced or metastatic cancer. The efficacy of graded exercise therapy (GET) and cognitive behaviour therapy (CBT) in reducing severe fatigue in cancer survivors has been shown, but the effectiveness for cancer patients in the palliative trajectory has not been demonstrated in controlled studies.
1. What are the effects of GET and CBT in severely fatigued patients receiving first line of palliative treatment for breast or colon cancer on fatigue severity compared to usual care?
2. What are the mediators of the change in fatigue brought on by GET and CBT? More specifically, are (a) and increased level of physical activity and/or physical fitness; or (b) a change in fatigue related cognitions, mediators for the expected reduction in fatigue brought on by the two interventions?
|- Healt Condition(s) or Problem(s) studied||Fatigue, Breast cancer, Bowel cancer, Cognitive behavior therapy, Graded exercise therapy|
|- Inclusion criteria||1. Diagnosed with locally advanced or metastatic breast or colon cancer;|
2. Age 18 or above;
3. Able to speak, read and write Dutch;
4. Being severely fatigued (CIS ≥ 35) for at least two weeks consecutively without known and treatable somatic causes, other than cancer;
5. Scheduled for first line of palliative systemic treatment.
|- Exclusion criteria||1. Contra-indication for exercise (a physical potency of walking six minutes successively is a minimum);|
2. Brain metastases;
3. Receiving treatment for a psychiatric disorder;
4. Karnofsky scale < 70.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2016|
|- Target number of participants||219|
|- Interventions||1. Graded exercise therapy (GET): Patients assigned to this condition will receive GET in addition to usual care. The GET will consist of weekly sessions of two hours resistance and aerobic training with a physical therapist during 12 weeks. In a second weekly session patients will practice without specific support by a physical therapist. GET will take place in small groups of maximal 5 patients and will be individually adjusted to patients’ abilities.|
2. Cognitive behaviour therapy (CBT): Patients in the CBT group will receive CBT for fatigue in addition to usual care. CBT will consist of ten individual one-hour sessions with a therapist over a period of 12 weeks. Based on the CBT for postcancer fatigue and CBT during curative cancer treatment a treatment protocol ‘CBT for fatigue in palliative cancer patients’ is developed. It consists of six modules aimed at factors that are thought to maintain fatigue. At baseline assessment it will be determined which factors are problematic for the particular patient. Relevant modules will be selected for each individual patient, which leads to a tailored-made intervention.
3. Care as usual: Patients assigned to this condition will receive care as usual. Patients will be treated for cancer in concordance with national and regional guidelines of the comprehensive cancer centres.
|- Primary outcome||Fatigue severity with subscale fatigue of the Checklist Individual Strength (CIS) ≥ 35 at 3 months. Follow up will be done at 4 months and 6 months.|
|- Secondary outcome||1. Quality of life assessed with subscale Global health status of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30 version 3.0) at baseline assessment, 3 months, 4 months, and 6 months;|
2. Functional impairments assessed by the total score on the Sickness Impact Profile 7 (SIP7) and the subscales Emotional functioning and Physical functioning of the EORTC QLQ-C30 at baseline assessment, 3 months, 4 months, and 6 months;
3. Fatigue severity will also be assessed with the subscale Fatigue of the EORTC QLQ-C30 version 3.0 at baseline assessment, 3 months, 4 months, and 6 months.
|- Timepoints||1. T0 baseline assessment;|
2. T1 following the intervention, approximately 3 months after T0;
3. T2 follow-up, 4 months after T0;
4. T3 follow-up, 6 months after T0.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. H. Poort|
|- CONTACT for SCIENTIFIC QUERIES||PhD. J.A. Knoop|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society|
|- Brief summary||Patients with advanced or metastatic breast and colon cancer can live with cancer for years, and this trajectory of palliative treatment is prolonged with improved oncological treatments. In addition to prolonging patients' lives, preserving their quality of life is the main aim during the palliative treatment. Fatigue has proven to be one of the symptoms significantly lowering the quality of life in cancer patients receiving palliative care. Until now there is no evidence based or generally accepted intervention to treat severe fatigue during the palliative trajectory. GET and CBT are two different and promising approaches to reduce fatigue. In this project we will test the direct and longer term effects of both interventions in a RCT in comparison with usual care on fatigue severity and quality of life.
Patients will be recruited from three hospitals in the Netherlands: Radboud University Nijmegen Medical Centre (Nijmegen), Ziekenhuis Gelderse Vallei (Ede) and Maxima Medisch Centrum (Eindhoven/Veldhoven). When accrual of patients is not sufficient in the three participating centres, other hospitals will be approached for participation.
|- Main changes (audit trail)|
|- RECORD||23-jan-2013 - 4-feb-2013|