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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00008022 |
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Date of registration:
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17/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fatigue Management in the oncological rehabilitation (FaM): Development and evaluation of trainings and aftercare modules for the coping of the cancer-related fatigue
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Scientific title:
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Fatigue Management in the oncological rehabilitation (FaM): Development and evaluation of trainings and aftercare modules for the coping of the cancer-related fatigue - FaM |
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Date of first enrolment:
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03/05/2015 |
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Target sample size:
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320 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00008022 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: crossover; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Heike
Kähnert |
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Address:
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Alte Vlothoer Straße 1
32105
Bad Salzuflen
Germany |
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Telephone:
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05222 186-3367 |
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Email:
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kaehnert@ifr-norderney.de |
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Affiliation:
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Institut für Rehabilitationsforschung, Norderney; Abt. Bad Salzuflen |
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Name:
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Heike
Kähnert |
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Address:
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Alte Vlothoer Straße 1
32105
Bad Salzuflen
Germany |
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Telephone:
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05222 186 3367 |
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Email:
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kaehnert@ifr-norderney.de |
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Affiliation:
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Institut für Rehabilitationsforschung, Norderney; Abt. Bad Salzuflen |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with a malignant tumor (ICD10: C50; C81-C96; C51-C58), which are tumour treated
Exclusion criteria: (1) Fatigue Screening: Cut-off < 4 (measuring instrument: numeric rating scale NCCN, 2014)
(2) Advanced tumor / palliative situation
(3) Adjuvante chemotherapy and/or radiotherapy is not concluded yet
(4) Insufficient German knowledge
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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G93.3
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Postviral fatigue syndrome
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Cancer-related fatigue of patients (ICD10: C50; C81-C96; C51-C58)
G93.3
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Intervention(s)
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Group 1: Control group: The study participants receive the clinic program (usual care). The participants obtain written brief informations (promotion of a healthy life style) at the end of the rehabilitation and one and four months after discharge in each case.
Group 2: Intervention group: The study participants take part in the clinic program (usual care) and additionally in the education programm „fatigue-management“. They receive personalized aftercare documents (also for the physician) at the end of the rehabilitation. In this case an action diary is used as an aftercare measure after one and four months of discharge.
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Primary Outcome(s)
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Measuring time: at the beginning, at the end, three and six months after the rehabilitation:
multidimensional fatigue inventary (measuring instrument MFI; Smets 1995)
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Secondary Outcome(s)
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Measuring time: at the beginning of the rehabilitation, 3 and 6 months after discharge:
1. Restriction of social participation (measuring instrument IMET, Deck et al., 2007);
2. The functional capability in occupation (measuring instrument IRES-3; Bührlen et al. 2005);
3. Quality of life (measuring instrument EORTC-QLQ-C30: Aaronson et al. 1993)
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Source(s) of Monetary Support
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Verein zur Förderung der Rehabilitationsforschung e.V., Norderney
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Ethics review
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Status: Approved
Approval date: 11/03/2015
Contact:
ethik-kommission@aekwl.de
Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
+49-251-9292460
ethik-kommission@aekwl.de
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