Fatigue Management in the oncological rehabilitation (FaM): Development and evaluation of trainings and aftercare modules for the coping of the cancer-related fatigue
Organizational Data
- DRKS-ID:
- DRKS00008022
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-04-17
- Last update in DRKS:
- 2023-11-09
- Registration type:
- Prospective
Acronym/abbreviation of the study
FaM
URL of the study
Brief summary in lay language
Cancer-related fatigue is a common symptom by cancer patients and can persist for months or even years following completion of treatment. Major symptoms are an unusual tiredness, exhaustion, listlessness and / or deficiency in attention and concentration. Fatigue has been found to negatively affected cancer patients self-care, quality of life, social activities and functional capability in workaday as soon as occupational. Within the study a fatigue-oriented patient education programme (intervention „fatigue management“) should be conceived with the rehabilitation team, be implemented in the process of a stationary rehabilitation and be evaluated. The aims of the FaM-training and aftercare measures are to diminish the symptoms of a fatigue and to improve the self-management with the fatigue so that the functional capability in workaday life as well as occupation can be promoted. The intervention „fatigue management” is checked by a process and outcome evaluation.
Brief summary in scientific language
Cancer-related fatigue is a common disorder of patients in all stages and of cancer survivors. It is defined as a subjective feeling of a physical, emotional and/or cognitive tiredness, which does not stand in connection with strenuous activities and hardly improves by sufficient recreational times or sleep. Major symptoms are an unusual tiredness, exhaustion, listlessness and deficiency in attention and concentration. Fatigue has been found to negatively affected cancer patients self-care, quality of life, social activities and functional capabilities in workaday life as well as occupation. Therefore patient education programmes are essential for coping a fatigue. Indeed, manualiized and evaluated programmes for fatigue do not exist for the stationary rehabilitation. The insufficient data situation concerning effective fatigue trainings in the oncological rehabilitation is the reason for a fatigue-oriented education programme (intervention „fatigue management“) which should be conceived with the rehabilitation team, be implemented in the process of a stationary rehabilitation and be evaluated. For aftercare measures, action diaries are used for the examination of the activity and energy management of the study participants. In the context of a pilot project, the consulting physician at home should be involved in the aftercare process. The intervention „fatigue management“ is checked on one hand within a process evaluation to be able to value the conversion, the contents, expiries, target group specificity as well as the acceptance comprehensively. On the other hand, the first data should be raised about the effectiveness of the intervention “fatigue management” (outcome evaluation). This is based on a prospective intervention control group design. Study participants are oncological patients. While the control group receives the clinic program (usual care), the intervention group takes additionally part in the intervention „fatigue management“. The study participants were interviewed with a questionnaire at the beginning, at the end, three and six months after the rehabilitation. The participants received one and four months after discharge written information (control group) or action diaries as an aftercare measure (intervention group). Main questions are: Is there a difference between the intervention group and control group up to six months after discharge from the rehabilitation concerning (a) the symptoms of the fatigue, (b) restriction of social participation, (c) functional capability in occupation.
Health condition or problem studied
- Free text:
- Cancer-related fatigue of patients (ICD10: C50; C81-C96; C51-C58)
- ICD10:
- G93.3 - Postviral fatigue syndrome
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- Measuring time: at the beginning, at the end, three and six months after the rehabilitation: multidimensional fatigue inventary (measuring instrument MFI; Smets 1995)
- Secondary outcome:
- 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)
Study Design
- Purpose:
- Treatment
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center onkologische Rehabilitation Bad Salzuflen
Recruitment period and number of participants
- Planned study start date:
- 2015-04-27
- Actual study start date:
- 2015-05-03
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-07-31
- Target Sample Size:
- 320
- Final Sample Size:
- 380
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 75 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Verein zur Förderung der Rehabilitationsforschung e.V. NorderneyKaiserstraße 2626548 NorderneyGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Rehabilitationsforschung, Norderney; Abt. Bad SalzuflenDr. Heike KähnertAlte Vlothoer Straße 132105 Bad SalzuflenGermany
- Telephone:
- 05222 186-3367
- Fax:
- 05222 186-3250
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ifr-norderney.de
Contact for Public Queries
- Address:
- Institut für Rehabilitationsforschung, Norderney; Abt. Bad SalzuflenDr. Heike KähnertAlte Vlothoer Straße 132105 Bad SalzuflenGermany
- Telephone:
- 05222 186 3367
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut für Rehabilitationsforschung, Norderney; Abt. Bad SalzuflenDr. Heike KähnertAlte Vlothoer Straße 132105 Bad SalzuflenGermany
- Telephone:
- 05222 186-3367
- Fax:
- 05222 186-3250
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ifr-norderney.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Verein zur Förderung der Rehabilitationsforschung e.V., NorderneyKaiserstraße 2626548 NorderneyGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität MünsterGartenstraße 210-21448147 MünsterGermany
- Telephone:
- +49-251-9292460
- Fax:
- +49-251-9292478
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-01-15
- Ethics committee number:
- 2015-026-f-S
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-03-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Kähnert, H., Niemann, J. & Leibbrand, B. (2019). Fatigue-Bewältigung nach Abschluss einer onkologischen Rehabilitation. Welche Unterstützung ist aus Patientensicht erforderlich? DRV-Schriften Bd. 117: S. 156-158.
- Leibbrand, B., Kähnert, H. & Maschke, J. (2018). Cancer-related fatigue, a problem in and after oncological rehabilitation. J Int Soc Rehabil Med 1, Suppl S1: p. 72.
- Kähnert, H., Maschke, J. & Leibbrand, B. (2018). Entwicklung und Evaluation eines Fatigue-Management Moduls für die onkologische Rehabilitation. Ergebnisse der FaM-Pilotstudie. DRV-Schriften Bd. 113: 389.
- Kähnert, H.; Maschke, J. & Leibbrand, B. (2017). Fatigue-Bewältigung in der onkologischen Rehabilitation. Welche Unterstützung ist aus Patientensicht erforderlich? DRV-Schriften Bd. 111, S. 382-383.
- Kähnert, H.; Maschke, J. & Leibbrand, B. (2017). Konzeption eines bedarfsorientierten Fatigue Schulungsmoduls für onkologische Rehabilitanden. Oncol Res Treat; 40 (suppl 1):15-16.
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- 2023-11-09
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- Tumorassociated fatigue is the most common comorbidity of cancer and its therapies. It is associated with physical, psychological and cognitive-mental states of exhaustion of different intensity, which can severely restrict participation in working life and every day life. To cope with the different symptoms and stresses, individually tailored multimodal therapy approaches are essential. The main objective of the FaM study was the development of needs-oriented fatigue management modules for therapy and aftercare for oncological rehab by the rehabilitation team. Further objectives were the process review and the evaluation of the FaM-modules. The qualitative and quantitative data were collected by the participating actors in a method triangulation. The following were carried out: Expert inter-views (a total of 17 participants in individual interviews) with the aim of evaluating the development process and the FaM-module therapy from the perspective of clinic employees and identifying suggestions for improvement. Group interviews before (4 GI with a total of 15 participants) and after (5 GI with a total of 18 participants) the introduction of the FaM module therapy with the aim of obtaining comparative information on the evaluation of fatigue-oriented therapies and identifying changes from the perspective of the rehabilitants. Patient surveys (n=380) before (n=186: control group, KG) and after (n=196: intervention group, IG) introduction of the FaM modules at five measurement points (start of rehab, end of rehab, 1-, 3- and 6-month after discharge) with the aim of obtaining initial information on the effects of the FaM modules (pilot study). Survey of the physicians at home providing further treatment in the intervention group (n=47) with the aim of being able to make statements about the rehab-discharge-report and the rehab aftercare recommendations. The module development strategies have proven their worth, as processes, documents and internal quality checks were considered goal-oriented and sensible by the employees, despite the increased workload. In addition, the continuous work in the expert groups promoted team development and consolidated a cooperative but also appreciative collaboration. This illustrates the importance of the rehab-team for the conception of new therapy offers. Key factors for the successful development and implementation of needs-oriented modules in the rehab team are summarized below: • Agreement on objectives and procedures with the clinic management and transparent and prompt dissemination of information to all rehab staff • Needs analyses with regard to the primary outcomes (target group: rehabilitants) • Current analyzes regarding existing clinic offerings for the primary outcomes (target group: rehab staff) • Ongoing expert group meetings / multi-professional rehab teamwork • Implementation and testing phase including review of process and structural quality (including staff surveys). • Review of the modules in routine care with regard to process-, structure- and outcome- quality (e.g. staff- and patient-surveys). For the FaM module therapy, offers were developed for the areas of sport, occupational therapy, psychology, nutritional advice and a doctor's lecture. This module was successfully implemented into routine care. The content and processes of the FaM module were accepted and positively evaluated by the rehab staff and rehabilitants (IG). Only the differentialdiagnosis of fatigue proved to be problematic according to the rehab-doctors and they would like further support in this regard. As supplementary measures, the rehabilitants requested more intensive psychological care and more individually oriented memory-/concentration training. The results of the group interviews showed that, compared to the control group, the intervention group perceived the rehabilitation to be more fatigue-oriented. By dealing with the issue of fatigue, the intervention group was better able to categorize the symptoms of exhaustion and "fears and feelings of helplessness" were reduced. By being taught fatigue-oriented coping strategies, the intervention group felt better prepared for their return to everyday life than the control group. The handouts and offers of the FaM aftercare module were also consistently rated as positive and practical, as they contained many suggestions for everyday life according to the intervention group. After discharge, the intervention group was able to implement strategies for dealing with their fatigue symptoms with the help of the energy diary by, among other things, organizing their everyday life in a way that conserved their energy, delegating work and learning to say "no". In addition, the majority changed their sports/exercise behavior and dietary habits in line with the rehab recommendations. However, it was not always possible for working participants to plan their day in a way that conserved their energy once they had returned to their workplace with fixed times and break rules. The summative evaluation (pilot study) show-ed significant group differences in favor of the intervention group with regard to general, physical and mental fatigue symptoms (primary target variables) as well as quality of life (secondary target variable) up to the 3-month follow-up, in each case with small to medium effect sizes. There were no intervention effects beyond the 3-month catamnesis. For the continuation of rehab aftercare recommendations, the physicians at home should take on a supporting role. According to the available study results, only a few physicians at home appear to take on such a function - in relation to coping with fatigue. According to three quarters of the IG participants surveyed, the topic of fatigue only played a subordinate role in the doctor-patient discussion up to three months after discharge. Patients with severe fatigue in particular often did not dis-cuss fatigue with their doctor. Furthermore, patients have experienced that their doctor is not fully informed about fatigue or does not want to discuss it, so that the discussions on the subject of fatigue were rated as not very helpful by the patients. As a result, patients would like their doctors to provide further training on the subject of fatigue. However, patients also emphasize that the physicians at home has largely adopted the recommendations from rehab. First and fore-most, they should increase their exercise and sports behavior. The physicians at home providing further treatment (n=47) largely rated the aftercare recommendations from the rehab-discharge-report positively. The majority of doctors considered them to be understandable and practical, but also helpful for discussions with patients and for further treatment. In addition, 90% of doctors consider the aftercare recommendations to be sufficient. However, they should be tailored more to the patient's situation (no standardized text modules) and contain detailed descriptions of the exercises (e.g. in the form of a weekly exercise plan). The physicians at home also expressed the wish to receive more information about fatigue. In a final assessment, three quarters of the doctors providing further treatment rated the rehabilitation as „(very) successful“ for their patients. The following modifications to the FaM modules can be derived from the study results: Development of target group-specific cognitive training units and job-oriented coping strategies for fatigue patients in everyday working life. In addition, educational materials and training courses on the subject of fatigue for doctors in private practice should be developed.