Physical activity for health in South Asian men with prostate cancer
| ISRCTN | ISRCTN44597684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44597684 |
| IRAS number | 355170 |
| Secondary identifying numbers | 2025-858, NIHR203315 |
- Submission date
- 01/10/2025
- Registration date
- 03/10/2025
- Last edited
- 03/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Prostate cancer is the most common male cancer, with over 50,000 men diagnosed each year in the UK. Studies have shown that different ethnic groups are more or less likely to develop prostate cancer, with South Asian men less likely to develop prostate cancer than white men. This suggests that being South Asian is a protective factor in whether men develop prostate cancer. However, a higher proportion of South Asian men are diagnosed with advanced prostate cancer and die from prostate cancer than non-South Asian men. This research aims to investigate a physical activity intervention of brisk walking in men of South Asian heritage who have been diagnosed with prostate cancer. The main aims of the study are to see whether men are willing to join the study, and whether they stick to doing the physical activity. Overall, the study will help determine if the intervention shows potential promise and if a larger study is worthwhile.
Who can participate?
Adult men (≥18 years) of South Asian heritage who have previously diagnosed or newly diagnosed with localised or locally advanced prostate cancer.
What does the study involve?
The study will assess the acceptability of a brisk walking intervention (30 minutes a day, 5 days a week) across two hospitals and the feasibility of conducting a larger clinical trial to investigate whether this intervention improves health outcomes. Men will be asked to participate in a three-month brisk walking intervention and will receive support to motivate them to do so. They will complete questionnaires and logs to record their step count for 1 week when they join the study, and after 6 weeks, 3 months and four months. Information will also be collected from their medical records and through focus groups to find out how they felt about the physical activity. Interviews will also be carried out with some clinicians at the two hospitals to find out how they felt about the physical activity intervention.
What are the possible benefits and risks of participating?
No benefits and risks provided at registration.
Where is the study run from?
The University of Bristol, UK.
When is the study starting and how long is it expected to run for?
July 2025 to January 2027
Who is funding the study?
NIHR Bristol Biomedical Research Centre, UK
Who is the main contact?
Dr Nour Alhusein, nour.alhusein@bristol.ac.uk
Contact information
Public, Scientific, Principal investigator
University of Bristol
1-5 Whiteladies Rd
Bristol
BS8 1NU
United Kingdom
 ORCID ID |
0000-0002-7578-4925 |
|---|---|
| Phone | +44 (0)1174552266 |
| Athene.Lane@bristol.ac.uk |
Public, Scientific
University Of Bristol
Canynge Hall
Bristol
BS8 2PS
United Kingdom
| ORCID ID |
0000-0001-7986-743X |
|---|---|
| Phone | +44 (0)1174559673 |
| nour.alhusein@bristol.ac.uk |
Study information
| Study design | Multicentre single-arm open-label feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Physical activity for health in South Asian men with prostate cancer: a feasibility study |
| Study acronym | Pro-SAPA |
| Study objectives | The primary research aim is to establish if a physical activity intervention for men of South Asian heritage with prostate cancer is acceptable and feasible for a larger-scale RCT. |
| Ethics approval(s) |
Approved 04/07/2025, West Midlands - Black Country Research Ethics Committee (2 Redman Place, Stratford/London, E20 1JQ, United Kingdom; +44 (0)207 104 8010, 207 104 8210, 2071048135; blackcountry.rec@hra.nhs.uk), ref: 25/WM/0113 |
| Health condition(s) or problem(s) studied | Physical activity in South Asian men with prostate cancer |
| Intervention | This research aims to investigate a physical activity intervention of brisk walking in men of South Asian heritage who have been diagnosed with prostate cancer. The study will look at the acceptability of the brisk walking intervention (30 minutes a day, on 5 days a week) across two hospitals, and the feasibility of later conducting a larger clinical trial to look at whether the brisk walking intervention improves health. Men will be asked to complete the brisk walking intervention for three months and will receive support to motivate them to do so. They will complete questionnaires and logs to record their step count for 1 week when they join the study, and after 6 weeks, 3 months and four months. Information will also be collected from their medical records and through focus groups to find out how they felt about the physical activity. Interviews will also be carried out with some clinicians at the two hospitals to find out how they felt about the physical activity intervention. The main aims of the study are to see whether men are willing to join the study, and whether they stick to doing the physical activity. Overall, the study will help determine if the intervention shows potential promise and if a larger study is worthwhile. |
| Intervention type | Behavioural |
| Primary outcome measure | The feasibility of recruiting men of South Asian heritage with prostate cancer to a physical activity intervention and adherence to the intervention will be measured using questionnaires and logs to record their step counts for 1 week when they join the study, and after 6 weeks, 3 months and four months |
| Secondary outcome measures | 1. Implementation fidelity: The extent to which participants complete the brisk walking intervention as prescribed (30 minutes/day, 5 days/week for 3 months). 2. Retention rate: Proportion of participants who remain in the study for the full duration of the intervention. 3. Feasibility of physical activity data collection: Completeness and usability of step count data recorded via pedometers/accelerometers and participant logs at baseline, 6 weeks, 3 months, and 4 months. 4. Feasibility of clinical and self-reported data collection: Completeness of participant-reported outcomes (e.g. symptoms, quality of life) and clinical data (e.g. PSA levels) from questionnaires and medical records. 5. Acceptability of the intervention: Participant and clinician feedback on the walking programme, gathered through focus groups and interviews. 6. Acceptability of trial procedures: Participant feedback on study processes, including reasons for declining participation. 7. Informing future trial design: Use of physical activity and outcome data to guide the development of a larger clinical trial. |
| Overall study start date | 04/07/2025 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 30 |
| Key inclusion criteria | Participants may enter the study if ALL of the following apply: 1. Adult men (≥18 years) 2. Previously diagnosed or newly diagnosed with localised or locally advanced prostate cancer 3. South Asian heritage 4. Capacity to give informed consent |
| Key exclusion criteria | Participants may not enter the study if ANY of the following apply: 1. Inability to give informed consent 2. Identified as unsuitable to participate by their clinician, e.g. due to co-morbidities, treatment being received, or any other contraindications to exercise 3. Use of a mobility aid other than a walking stick, which would prevent them from carrying out the brisk walking intervention 4. Inability to give informed consent |
| Date of first enrolment | 08/10/2025 |
| Date of final enrolment | 02/10/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Duckworth Lane
Bradford
BD9 6RJ
Bradford
BD9 6RJ
United Kingdom
Bristol
BS10 5NB
United Kingdom
Sponsor information
University/education
Beacon House, Queens Rd
Bristol
BS8 1QU
England
United Kingdom
| Phone | +44 (0)117 928 9000 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | https://www.bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Research organisation
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Biomedical Research Centre Bristol, National Institute for Health Research Bristol Biomedical Research Centre, NIHR Bristol BRC, Bristol BRC, Bristol Biomedical Research Centre
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | A publication policy will be developed, with authorship models agreed in advance with the TMG. The findings will be disseminated by usual academic channels, i.e. presentation at international meetings, as well as by peer-reviewed publications and through patient organisations and newsletters to patients, where available. Where possible, information will be disseminated to participating sites and participants in line with timelines for academic audiences (i.e. participant and sites being informed of the study results on or shortly after the date the academic paper is published). Before dissemination materials are drafted, PPI members should be consulted on the proposed methods for dissemination to non-academic audiences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in the University of Bristol Research Data Repository with restricted access data.bris (https://data.bris.ac.uk/data/) |
Editorial Notes
03/10/2025: The date of first enrolment was changed from 02/10/2025 to 08/10/2025.
02/10/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
