|- candidate number||12860|
|- NTR Number||NTR3483|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jun-2012|
|- Secondary IDs||5264 KWF /Alpe d Huzes|
|- Public Title||Investigating two home-based interventions for people suffering from chronic fatigue after cancer.|
|- Scientific Title||The effectiveness and working mechanisms of two different home-based interventions for people suffering from chronic fatigue after cancer.|
|- ACRONYM||Fitter na kanker|
|- hypothesis||We hypothesize that fatigue will significantly be reduced in participants in both intervention groups, compared to participants in the minimal control intervention. We expect that this decrease in fatigue is correlated with an increase in wellbeing. In addition, we hypothesize that both intervention groups will show a significant increase in work ability, thus 1) more people will return to work, 2) on average, working hours per week is increased, and 3) on average, self-perceived ability to work is increased. The AAF is expected to have effect through increasing and the enhancement of balance in physical activity. MBCT is expected to have effects through an increase in the level of mindfulness. Both interventions are expected to have effect through non-specific variables as alliance and the expectation by the client that the intervention offered to him is suitable for reducing fatigue. In addition the outcome of both interventions may be mediated by a better sleep quality.|
|- Healt Condition(s) or Problem(s) studied||Chronic cancer related fatigue (CCRF)|
|- Inclusion criteria||1. Checklist Individual Strength (CIS) fatigue subschale score of 35 or higher (administered via website);|
2. Completion of treatment for cancer at least half a year ago (determined by self-report at the start of the study and checked in medical file afterwards);
3. Disease-free, as defined by the absence of cancer activity parameters (self-report at start and checked in medical file afterwards);
4. Age older than 19 years (self-report);
5. Age at disease onset minimal 18 years (self-report);
6. Capable of reading Dutch language (self-report).
|- Exclusion criteria||1. Severe psychiatric morbidity as severe depression, history of psychoses, schizophrenia, alcohol- or drug dependence (self-report and checked in medical file afterwards);|
2. Recurrence of cancer during the study (self-report and checked in medical file afterwards);
3. Patients who have a recurrence during participation in this study will be excluded from the analyses but not from the interventions.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-jun-2016|
|- Target number of participants||330|
|- Interventions||AAF (Ambulant Activity Feedback):|
Patient will receive a tri-axial accelerometer (a mtx-w sensor) and a Personal Digital Assistant (PDA). The PDA displays the patient's activity and the goal activity. Patients will wear these devices during their everyday live, for a maximum of 14 hours each day (8.00 till 22.00 oíclock). The intervention consists of a monitoring and a feedback period. During the monitoring part, patients will be monitored for seven days in their own environment to establish a baseline daily activity pattern (week 0). No feedback will be given to the patient during this period. During the feedback period, patients are instructed to use the PDA for regulation of their daily physical activities. Together with their personal physiotherapist the patient will agree on a individually tailored goal value. This goal value will help the patient to balance the physical activity pattern, as more balance in the activity pattern over the day is expected to decrease the level of fatigue. In addition, patients report about their experience to their personal physiotherapist by e-mail weekly and will receive e-mail feedback on a predetermined day of the week.
Mindfulness Based Cognitive Therapy (MBCT) adds elements of cognitive therapy to the Mindfulness Based Stress Reduction (MBSR) program that was developed by John Kabat-Zinn. In contrast to Cognitive Behavioural Therapy (CBT), MBCT does not emphasize changing the content or specific meaning of negative automatic thoughts. It simply attempts to teach the participant to use a detached perspective as a skill to prevent the escalation of automatic negative thinking patterns. MBCT also teaches patients how to accept physical limitations, pain, or fatigue. The MBCT online intervention follows the same protocol and uses the same reader and homework assignments as the face-to-face MBCT protocol (van der Lee and Garssen, 2010), based on the original protocol designed by Segal et al (2001) for relapse of depression. Patients start the intervention by studying the reader for that first week and downloading an MP3 file with mindfulness exercises, which they are asked to practice every day. The reader holds information and instructions about a particular theme each week and psycho-educational information about cancer and fatigue and how mindfulness can help reduce CCRF. They register their experience with the exercise in their homework logs during the week and the therapist delivers a reaction to the logs on a predetermined day of the week. Exploration of experiences with the mindfulness exercises is essential in MBCT, therefore therapists will relate their feedback to the maintenance of fatigue. Weekly, for nine weeks, a new reader will appear on the website with new MP3 mindfulness exercises. Patients cannot continue with a next session before they have registered their experience with homework assignment of the previous week. All patients will be guided by two therapists, both having more than 5 years of experience with MBCT in cancer patients.
Minimal intervention control condition:
Patients that are assigned to the control condition, thus the minimal intervention condition, will receive weekly supportive e-mail containing standard texts with psycho-education and information about CCRF. Participants cannot reply to these e-mails in order to keep this intervention minimal and standard. This design was copied from the online alcohol addiction intervention study from Marloes Postel. In this trial the minimal intervention led to a minimal dropout rate of 15% in the control condition.
|- Primary outcome||Fatigue will be assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS).
The Shortened Fatigue Scale (Verkorte Vermoeidheids Vragenlijst) is a shortened, and valid version of the CIS, which contains 4 items. It will be used to assess fatigue four times during the intervention.|
|- Secondary outcome||1. Mental state: Affect (Positive And Negative Affect Scale (PANAS)) and psychological distress (Hospital Anxiety and Depression Scale (HADS));|
2. Work ability (return to work, hours work per week): Trimbos/iMTA questionnaire for Costs associated with psychiatric Illness (TIC-P);
3. Self perceived ability to work: first item of the Work Ability Index (WI).
Other study parameters:
1. Physical activity: accelerometer;
2. Perceived physical activity: Physical Activity Scale for the Elderly (PASE);
3. Level of Mindfulness: Freiburg Mindfulness Inventory, short form (FMI-S);
4. Subjective sleep quality: Subjective Sleep Quality Scale (SSQS);
5. Credibility and expectancy of the intervention: Credibility/Expectancy Questionnaire (CEQ);
6. Working alliance with personal therapist: working alliance inventory, short form (WAI-S);
7. Sense of control over fatigue: Self-Efficacy Scale (SES);
8. Self-efficacy over physical activity: Rodgers' nine-item scale.
Moderator and control variables:
1. Demographic and psychological parameters and participant's medical history.
To understand how interventions cause change, fifteen participants from each intervention condition will be interviewed both before and after the intervention. In that way, it is possible to acquire knowledge about (a) their pre-treatment expectancies and how they may have changed during the intervention, (b) which elements they found most helpful and least helpful, (c) how they had experienced the relation with their online therapist, and (d) if this relation was important for their motivation and compliance.
|- Timepoints||Patients will fill out questionnaires at the start of the intervention (T0), three-months later (T1), and after three months of follow up (T2). After T2, patients in the control condition will be offered one of the interventions at random. The intervention groups will be followed for another 6 months (T3; follow-up). |
|- Trial web site||www.fitternakanker.nl|
|- CONTACT FOR PUBLIC QUERIES||MSc. F.Z. Everts|
|- CONTACT for SCIENTIFIC QUERIES||MSc. M.D.J. Wolvers|
|- Sponsor/Initiator ||Roessingh Research and Development b.v., Helen Dowling Instituut|
(Source(s) of Monetary or Material Support)
|Alpe díHuZes Foundation, KWF Kankerbestrijding|
|- Brief summary||About a quarter of cancer survivors suffer from severe chronic fatigue. Chronic fatigue may persist for many years after treatment and has a considerable impact on a patientís life because of its interference with daily activities and because it hinders patients to participate optimally into the society and work. Physical activity interventions and psychosocial interventions, specifically designed to reduce fatigue, seem effective in reducing fatigue. However, there is a considerable number of severely fatigued cancer survivors who do not have access to these specific interventions. Delivering interventions through the internet enables treatment at home and as such makes interventions available for patients who do not have the time or energy to travel. This study aims at investigating the efficacy of two home-based interventions, an Ambulant personalized Activity Feedback intervention (AAF) and an online Mindfulness-Based Cognitive Therapy (MBCT) in reducing Chronic Cancer-Related Fatigue compared to a control group. In addition, we will study how these interventions work and what type of intervention is best for whom. More specifically we will test if these interventions reduce fatigue by treatment specific mechanisms as increasing activity and balancing activities during the day and increasing mindfulness and sleep quality or by more generic mechanisms as working alliance and clientís expectation about the effect of the intervention. |
|- Main changes (audit trail)|
|- RECORD||4-jun-2012 - 10-mrt-2013|