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

The effectiveness and working mechanisms of two different home-based interventions for people suffering from chronic fatigue after cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22972
Enrollment
330
Registered
2012-06-04
Start date
2012-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering from chronic cancer related fatigue (CCRF)

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 patients activity and the goal activity.

Sponsors

Roessingh Research and Development and Helen Dowling Institute Helen Dowling Instituut Rubenslaan 190 3582 JJ Utrecht Postbus 85061 3508 AB Utrecht Tel +31(0)302524020 Fax +31(0)302524022 www.hdi.nl
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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.

Contacts

Public ContactF.Z. Everts

Helen Dowling Institute Scientific research P.O. box 80 3720 AB

feverts@hdi.nl+31 (0)30 2524020

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)