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CoCo in oncology.


- candidate number10247
- NTR NumberNTR3025
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-aug-2011
- Secondary IDsP11-28 METC Medisch Spectrum Twente
- Public TitleCoCo in oncology.
- Scientific TitleCoCo in cancer rehabilitation: Evaluation of use, satisfaction and clinical effects.
- ACRONYM
- hypothesisCancer is a common disease with serious consequences for patientís physical and psychosocial functioning. These consequences may last for a long time, even after completion of the curative treatment. To overcome cancer-related problems and to improve quality of life, many cancer survivors participate in a multidimensional rehabilitation program. One drawback of these programs is that they require a lot of contact time between the therapist and the patient. To improve the efficiency of the treatment, the CoCo (ConditionCoach) oncology application will be implemented in the traditional cancer treatment of Het Roessingh, center for rehabilitation, This application can be used by patients at home and can partially replace traditional (face-to-face) treatment.

Goal of this study is to evaluate the use of and satisfaction with the CoCo oncology application among cancer survivors and to study the clinical effectiveness of the implementation of the CoCo oncology application in the traditional treatment.
- Healt Condition(s) or Problem(s) studiedCancer related physical and mental symptoms
- Inclusion criteria1. Age > 18 years;
2. Fnished primary curative treatment for > 3 months (except herceptin, Tamoxifen, etc.);
3. Cancer related symptoms;
4. Sufficient physical capacities to participate in sport activities twice a week;
5. Mild to moderate psychosocial symptoms and fatigue (Symptom Checklist-90 < 165; Checklist Individual Strength < 46).
- Exclusion criteria1. Palliative demand for care;
2. Serious psychopathology;
3. Insufficient understanding of the Dutch language.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate1-feb-2013
- Target number of participants32
- InterventionsThe CoCo oncology application is a technology assisted service to improve physical and mental fitness. The aplication consists of two modules for the patient:
1. Activity registration with feedback;
2. Online exercise program values-based choices.
The application further contains a module telemonitoring (for the therapist), which summarizes several patient results. The application can be used by patients at home.

Three conditions will be compared:
1. Traditional treatment (based on historical data);
2. Traditional treatment + CoCo oncology application;
3. Shortened traditional treatment + CoCo oncology application.
- Primary outcomeThe implementation of the CoCo oncology application will be evaluated in terms of use, satisfaction with the technology, satisfaction with the treatment and quality of the provision of the services.
- Secondary outcomeThe clinical effectiveness will be evaluated in terms of disease burden, quality of life, physical functioning, fatigue, anxiety and depression.
- TimepointsUse of the application (login, number and type of exercises, films and questionnaires that have been filled in and/or seen) will be registered by the system.

Satisfaction with the technology (UTAUT questionnaire) and quality of the provision of services (SERVQUAL questionnaire) will be assessed at baseline (expectations) and post-treatment (experiences).

Satisfaction with the treatment (CSQ) will be assessed post-treatment.

Clinical outcomes will be assessed at baseline (pre-treatment), post-treatment and at 3-months follow-up. Clinical outcomes are: disease burden (10-point NRS), quality of life (EORTC_QLQ), physical functioning (SF-36), fatigue (CIS-20, anxiety (HADS-A) and depression (HADS-D).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R. Huis in 't Veld
- CONTACT for SCIENTIFIC QUERIESDr. R. Huis in 't Veld
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
SenterNovem
- PublicationsN/A
- Brief summaryCancer is a common disease with serious consequences for patientís physical and psychosocial functioning. These consequences may last for a long time, even after completion of the curative treatment. To overcome cancer-related problems and to improve quality of life, many cancer survivors participate in a multidimensional rehabilitation program. To improve the efficiency of the treatment, the CoCo (ConditionCoach) oncology application will be implemented in the traditional cancer treatment of Het Roessingh, center for rehabilitation, Enschede, The Netherlands. The CoCo oncology application is a technology assisted service to improve physical and mental fitness. The application consists of two modules for the patient: (1) activity registration with feedback and (2) online exercise program values-based choices. The application further contains a module telemonitoring (for the therapist), which summarizes several patient results. This application can be used by patients at home and can partially replace traditional (face-to-face) treatment.

Goal of this study is to evaluate the use of and satisfaction with the CoCo oncology application among cancer survivors and to study the clinical effectiveness of the implementation of the CoCo oncology application in the traditional treatment. Three conditions will be compared: (1) traditional treatment (based on historical data), (2) traditional treatment + CoCo oncology application, (3) shortened traditional treatment + CoCo oncology application.

Primary outcomes are use of the application, satisfaction with the technology (UTAUT questionnaire), satisfaction with the treatment (CSQ) and quality of the provision of the services (SERVQUAL questionnaire). Secondary outcomes are disease burden, quality of life, physical functioning, fatigue, anxiety, and depression.
- Main changes (audit trail)
- RECORD16-aug-2011 - 4-sep-2011


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