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van CCT (UK)

van CCT (UK)

An explorative study on physiological and neurophysiological determinants of fatigue in cancer survivors.

- candidate number5370
- NTR NumberNTR1685
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2009
- Secondary IDsno 2008-200 CMO UMC St. Radboud
- Public TitleAn explorative study on physiological and neurophysiological determinants of fatigue in cancer survivors.
- Scientific TitleAn explorative study on physiological and neurophysiological determinants of fatigue in cancer survivors.
- ACRONYMFICS (Fatigue In Cancer Survivors)
- hypothesis1. What are characteristic (neuro)physiological factors of fatigue in disease-free cancer patients?
2. To which degree can these factors be influenced by Cognitive Behavior Therapy?
- Healt Condition(s) or Problem(s) studiedCancer, Fatigue
- Inclusion criteria1. Treated for a malignant, solid tumor;
2. Completion of treatment for cancer minimal 1 year ago;
3. Disease-free, as defined by the absence of somatic disease activity parameters;
4. Age between 19 and 65;
5. Age at disease onset minimal 18.
- Exclusion criteria1. Current psychological or psychiatric treatment;
2. Physical comorbidity which could explain the fatigue;
3. Contra-indication for MR-examinations;
4. Treatment with anti-depressive drugs, anti-epileptic drugs, or benzodiazepines;
5. Insufficient command of the Dutch language to fill out questionnaires.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate1-okt-2012
- Target number of participants78
- InterventionsIn this explorative study, disease-free cancer patients who finished treatment for cancer at least one year ago, will be approached for this study. Patients who are suitable for this study, based on the in- and exclusion criteria, will be asked to give written informed consent. Next, baseline assessment will take place in these patients. Based on the Checklist of Individual Strength Fatigue score, patients will be divided into a non-fatigued and a severely fatigued group. Differences in (neuro)physiological factors will be assessed between the non-fatigued and fatigued group. After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behavior Therapy, especially designed for fatigued cancer patients, or to be placed on a waiting list. At the end of the therapy, after 6 months, a second assessment will take place in the group of fatigued patients. This assessment will include the same measurements as at baseline. The fatigued patients on the waiting list will then start with Cognitive Behavior Therapy.
- Primary outcomeThe baseline and second assessment both include:
1. Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy to assess brain morphology and brain metabolites, respectively;
2. A two-minute endurance test will be administered at maximal voluntary (isometric) contraction to assess peripheral and central fatigue. During the test changes in EMG and force indicate peripheral fatigue, while central fatigue is studied by the twitch interpolation technique;
3. A maximal exercise test will be performed to assess physical fitness and deconditioning;
4. Fatigue severity will be measured using the Checklist Individual Strength. The Checklist Individual Strength is designed to measure fatigue severity, concentration, motivation, and physical activity;
5. Additional questionnaires will be used to measure general health, the impact of the disease on daily life, difficulties in getting over the cancer experience, depression, anxiety, sleep, social support, physical activity, quality of life, and self efficacy;
6. Patients will perform neurological tests to assess information processing and motor speed;
7. Blood and urine samples of the patients will be analyzed to find possible explanations for cancer related fatigue;
8. Daily observed fatigue will be measured during a two-week period with the Self-Observation List. The latter instrument gives the actual level of daily fatigue and will be used during two weeks;
9. Daily activity will be measured during two weeks using an actometer. The actometer used is a motion-sensing device that can register and quantify human physical activity. To assess the effect of the maximal exercise test on the daily activity of patients, they will wear the actometer for an additional five days after the maximal exercise test.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Nijmegen Medical Center, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryFatigue long after treatment for cancer is a frequently occurring problem, which has important consequences for quality of life in these patients. Identification of characteristic (neuro)physiological factors of fatigue in disease-free cancer patients may not only serve a theoretical understanding of this invalidating condition, but may also provide an objective biological marker that could support the diagnosis and follow-up treatment. The identification of (neuro)physiological factors which play a role in fatigue after cancer may aid in the early recognition of patients who are at risk for developing fatigue and may lead to early intervention and/or different treatment strategies.
- Main changes (audit trail)09-Apr-2012: Target number of participants changed from 134 to 78. This is the minimal needed amount of participants - NM
- RECORD24-feb-2009 - 13-apr-2012

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