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21 March 2013
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| [ Print-friendly version ] |
| RESTART: Rehabilitation Evaluation in Survivors of Testicular Cancer After Radical Treatment |
| ISRCTN | ISRCTN77608320 |
| DOI | 10.1186/ISRCTN77608320 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | RESTART: Rehabilitation Evaluation in Survivors of Testicular Cancer After Radical Treatment |
| Scientific title | RESTART: Rehabilitation Evaluation in Survivors of Testicular Cancer After Radical Treatment: a pilot Study |
| Acronym | RESTART |
| Serial number at source | RESTART-2011 |
| Study hypothesis |
The primary aim is to establish the components of a rehabilitation programme for testis cancer. In addition, we wish to measure the magnitude of effect using the change in Hospital Anxiety and Depression Scale (HADS) anxiety sub-score from pre to post the programme.
The median return to work/education time will also be estimated for the participants as background information for designing any subsequent phase III study. The aim is to then set up a phase III trial to definitively investigate if such a programme may influence early reduction in treatment related anxiety and the time to return to employment following radical treatment of testis cancer compared to the current standard of care. Secondary aims are assessment of the effect of the rehabilitation programme on Quality of Life (QOL), HAD depression sub-score, fatigue, exercise capacity and body mass index (BMI). |
| Lay summary | http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-rehabilitation-programme-men-completed-treatment-testicular-cancer-restart? |
| Ethics approval | West of Scotland REC 1, Date of Submission to REC: 17th June 2011, REC Approval: 18th August 2011, REC Ref: 11/WS/0007 |
| Study design | Phase II non randomised feasibility study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Testicular cancer |
| Participants - inclusion criteria |
1. Ability to commence rehabilitation programme within 8 weeks of confirmed completion of all radical treatment for testis cancer ((including all surgical procedures, such as retroperitoneal lymph node dissection) If surveillance, the date this is confirmed as their management / Date of recovery from last surgical procedure or chemotherapy).
2. No major cardio-respiratory problems, which would influence participation in an exercise programme. 3. Male aged 16 or over 4. Ability to provide written informed consent 5. Geographically close enough to site of rehabilitation programme or prepared to travel necessary distances involved |
| Participants - exclusion criteria |
1. Alcohol / drug dependency
2. Cognitive dysfunction 3. Psychological distress that the referring clinician feels may make the individual not suitable for trial |
| Anticipated start date | 19/01/2012 |
| Anticipated end date | 01/01/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 32 |
| Interventions |
All patients who enter the study will take part in a six week rehabilitation programme in order to facilitate improvement in functional ability and psychological well being following treatment of testicular cancer. Specific components will be introduced to address the needs of this particular population group.
In addition to the exercise component, recreational and social elements to the programme, topics that will be included are:- 1. Healthy living advice (alcohol, diet, exercise, sun awareness) 2. Return to work 3. Role of Occupational Health Physician or Nurse 4. Financial issues 5. Insurance 6. Advice on recognising recurrence 7. Accessing more information and support service for testis cancer 8. Coping with life after a serious illness – how to be positive 9. Fertility As part of the exercise component, participants will wear a pedometer for the 6 weeks the rehabilitation programme takes place. They will record readings in an exercise diary each night. In addition they will record daily exercise activity. Each of the components will be delivered by a specialist in that field. In addition, the course will be lead by co-ordinator with background experience in cancer rehabilitation. |
| Primary outcome measure(s) |
Pilot study to establish the components of a rehabilitation programme for testis cancer and the effect of the programme by measuring change in the HADS anxiety sub score-from pre to post participation.
The aim is to then set up a phase III trial to definitively investigate if such a programme may influence early reduction in treatment related anxiety and the time to return to employment following radical treatment of testis cancer compared to the current standard of care. |
| Secondary outcome measure(s) |
Assessment of the effect of the rehabilitation programme on:
1. Fatigue 2. Exercise capacity 3. HADS depression sub score 4. BMI Measured pre and post rehabilitation programme. |
| Sources of funding |
1. Macmillan Cancer Support (UK)
2. National Institute for Health Research Cancer Research Network (NCRN) |
| Trial website | |
| Publications | |
| Contact name | Dr Jeff White |
| Address |
The Beatson West of Scotland Cancer Centre
Level 3 1053 Great Western Road |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Tel | +44 (0)141 301 7060 |
| jeffwhite@nhs.net | |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Address |
c/o Dr Nathaniel Brittain
Research and Development Central Office The Tennent Institute, 1st Floor Western Infirmary 38 Church Street |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Sponsor website: | http://www.nhsggc.org.uk/r&d |
| Date applied | 15/01/2013 |
| Last edited | 29/01/2013 |
| Date ISRCTN assigned | 29/01/2013 |
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