Investigating two home-based interventions for people suffering from chronic fatigue after cancer

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2012
INTERVENTION: 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 o’clock). 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. Online MBCT: 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 CONDITION: ; Chronic cancer related fatigue (CCRF) ; ; 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: ; ; Mediating factors: ; ; 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. ; ; ; INCLUSION CRITERIA: 1. Checklist Individual Strength (CIS) fatigue subschale score of 35 or higher (administered via website); ; 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. 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).
Epistemonikos ID: 985044ce056531e0ce4ba9db015ed75ce45ea1fc
First added on: Aug 22, 2024