PRO-REHAB - The development and pilot trial of two programmes of rehabilitation for cancer patients
| ISRCTN | ISRCTN14861313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14861313 |
| Secondary identifying numbers | 15361 |
- Submission date
- 14/01/2015
- Registration date
- 15/01/2015
- Last edited
- 09/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Dr Joanne Fisher
Scientific
Scientific
University of Warwick
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Study information
| Study design | Randomised; Interventional and Observational |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | PRO-REHAB - The development and pilot trial of two programmes of rehabilitation for cancer patients: a pilot randomised controlled trial |
| Study acronym | PRO-REHAB |
| Study hypothesis | What effect on participants’ quality of life, well-being, physical and psychological functioning and perception of distress does: (i) an individualised home-based rehabilitation programme, facilitated by allied health professionals or (ii) a group-based rehabilitation programme, facilitated by a multidisciplinary team of allied health professionals have, compared to usual care? More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=15361 |
| Ethics approval(s) | NRES Committee West Midlands, Solihull, ref: 13/WM/0340 |
| Condition | Rehabilitation for cancer patients following the end of their treatment |
| Intervention | The two intervention arms of this three-arm randomised control trial are home-based rehabilitation and group-based rehabilitation programmes. The home-based programme is an individualised holistic rehabilitaion programme, developed jointly by the participant and a personal allied health professional and delivered over 10 weeks. Particpants can choose from a wide range of areas, activities and topics that they would like to improve or change in their lives. Participants who would like to improve activity will recieive an individualised exercise programme, developed by specialist exercise physiologists. The programme will be supported by a workbook with a goal diary and CD-based relaxation. The group-based programme is an holistic rehabilitaion prgramme, developed jointly by the group (maximum 10 people) and a multi-disciplinary team of allied health professionals and delivered over 10 weeks. Participants can choose from a wide range of areas, activities and topics that they would like to improve or change in their lives. Participants who would like to improve activity will recieive an individualised exercise programme, developed by specialist exercise physiologists. The programme will be supported by a workbook with a goal diary and CD-based relaxation. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Identification and recruitment of participants, and recruitment strategies 2. Sample size calculations for a future multi-centre trial |
| Secondary outcome measures | 1. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-EORTC QLQ-C30 (version 3) 2. Generalised Anxiety Disorder Assessment (GAD-7) 3. Euroqol quality of life questionnaire (5 item) - EQ5D-5L 4. Patient Health Questionnaire (PHQ-9) 5. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 6. The Distress Thermometer 7. Incremental Shuttle Walk Test (ISWT) score 8. Joint British Societies recommendations on the prevention of Cardiovascular Disease (JBS3) score 9. Malnutrition Universal Screening Tools score (MUST) |
| Overall study start date | 02/07/2014 |
| Overall study end date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 170; UK Sample Size: 170; Description: A sample size of 150 patients (50 patients on each arm) in the pilot trial will be sufficient to give an indication of the feasibility of the full trial. This sample size will allow the mean difference in pre and post intervention scores on the global quality of life scale from the EORTC QLQ-C30 questionnaire to be estimated to within 6% with 95% confidence, i.e. 95% confidence interval (CI) width of 12%, for each arm, assuming a standard deviation of 20. |
| Participant inclusion criteria | Patients: 1. With cancer (breast, colorectal, head and neck, lung and prostate) of any stage, will be invited to participate along with their carers 2. Who have completed the initial phase of intensive intervention (surgery, chemotherapy and/or radiotherapy) 3. Are able to read written and comprehend spoken English 4. Are aged 18 years and over 5. Are able and willing to give informed consent; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified |
| Participant exclusion criteria | Patients: 1. Aged less than 18 years 2. With a history of severe psychiatric disorder |
| Recruitment start date | 02/07/2014 |
| Recruitment end date | 31/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Warwick
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Sponsor information
University of Warwick
Hospital/treatment centre
Hospital/treatment centre
Warwick Medical School
Coventry
CV4 7AL
England
United Kingdom
"ROR" |
https://ror.org/01a77tt86 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/08/2021: Internal review.
