PRO-REHAB - The development and pilot trial of two programmes of rehabilitation for cancer patients
| ISRCTN | ISRCTN14861313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14861313 |
| Protocol serial number | 15361 |
| Sponsor | University of Warwick |
| Funder | National Institute for Health Research |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional and Observational |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Identification and recruitment of participants, and recruitment strategies |
| Key secondary outcome measure(s) |
1. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-EORTC QLQ-C30 (version 3) |
| Completion date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 170 |
| Key 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 |
| Key exclusion criteria | Patients: 1. Aged less than 18 years 2. With a history of severe psychiatric disorder |
| Date of first enrolment | 02/07/2014 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/08/2021: Internal review.
