Investigating the relationship between physical activity and side effects associated with systemic anti-cancer therapies
| ISRCTN | ISRCTN16575002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16575002 |
| Integrated Research Application System (IRAS) | 346177 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | Newcastle upon Tyne Hospitals NHS Foundation Trust |
- Submission date
- 29/01/2026
- Registration date
- 05/02/2026
- Last edited
- 02/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Cancer treatments such as chemotherapy and other systemic anti-cancer therapies (SACT) can cause side effects that affect people physically and emotionally, impacting daily activities, quality of life and wellbeing. Research suggests physical activity may help people cope better with treatment, but it is not yet clear how practical it is to measure activity levels or deliver exercise programmes during SACT. Before a larger study can be developed, we need to understand whether this type of research is feasible.
The ACTIVATE study will explore whether it is possible to recruit participants, collect the necessary information and, in some cases, deliver an exercise programme to people with cancer starting their first course of SACT. The study will include adults with breast, colorectal, prostate or lung cancer.
Who can participate?
Patients aged ≥16 years who have been diagnosed with breast, lung, colorectal or prostate cancer and are planned to commence first-line SACT.
What does the study involve?
This feasibility study will recruit 16 participants, eight will take part in Part One and a separate group of eight in Part Two.
The study has two parts.
Part One will examine whether it is feasible to measure physical activity before treatment begins and to collect information on side effects and wellbeing during SACT. Participants will take part for up to six months. All study visits will take place alongside routine hospital appointments for standard cancer care, with no additional visits required. Participants are expected to attend approximately 4–10 study visits, depending on treatment schedules.
Part Two follows a similar approach, but participants will also receive a personalised exercise programme starting 2–4 weeks before SACT and continuing during treatment. Participants will attend a physiotherapy visit to receive their exercise programme, which may take place face to face or online. Participation will last for up to six months and involve a similar number of visits.
This study will provide essential information to help design a future, larger study to improve care for people undergoing SACT.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital, High Heaton, UK.
When is the study starting and how long is it expected to run for?
February 2026 to February 2027.
Who is funding the study?
Newcastle upon Tyne Hospitals NHS Foundation Trust, UK.
Who is the main contact?
Dr Ben Hood, ben.hood@nhs.net
Contact information
Scientific, Public, Principal investigator
Sir Bobby Robson Cancer Trials Research Centre
Northern Centre for Cancer Care
Level 2, Freeman Hospital, High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
 ORCID ID |
0000-0003-1982-6745 |
|---|---|
| Phone | +44 01912139217 |
| ben.hood@nhs.net |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Non-randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Sequential | |
| Purpose | Device feasibility, Health services research, Supportive care | |
| Scientific title | A feasibility study investigating the relationship between physical activity and side effects associated with systemic anti-cancer therapies | |
| Study acronym | ACTIVATE | |
| Study objectives | To evaluate the feasibility and acceptability of delivering a personalised prehabilitation programme prior to and during systemic anti-cancer therapy. • To assess the feasibility of recruiting and retaining participants to the study. • To explore the impact of prehabilitation on physical activity levels, quality of life and treatment tolerance during systemic anti-cancer therapy. • To assess the safety and adherence of the prehabilitation intervention. • To generate data to inform the design of a future larger-scale evaluation. | |
| Ethics approval(s) |
Approved 29/01/2026, London - Harrow Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)300 303 8490; harrow.rec@hra.nhs.uk), ref: 26/LO/0051 | |
| Health condition(s) or problem(s) studied | Cancer-related functional decline and reduced physical activity in adults receiving systemic anti-cancer therapy | |
| Intervention | Participants will be identified through routine oncology clinics and screened for eligibility prior to commencing first-line systemic anti-cancer therapy (SACT). Following informed consent and baseline assessment, participants will be enrolled into one of two sequential cohorts. Participants enrolled during the first recruitment phase (control cohort) will undergo baseline assessment and receive usual oncology care only, with no additional prehabilitation intervention. Participants enrolled during the second recruitment phase (intervention cohort) will undergo the same baseline assessment and, in addition to usual care, will receive a personalised prehabilitation programme. The prehabilitation programme consists of an individualised physical activity plan developed following baseline assessment and supported by a physiotherapist. The intervention is delivered using a hybrid model combining face-to-face and supported home-based exercise. The intervention commences prior to SACT and continues throughout the period of systemic treatment. Participants will be observed from enrolment through completion of systemic anti-cancer therapy. The total duration of follow-up for each participant is from baseline to completion of SACT. This is a pragmatic, non-randomised study using sequential cohort allocation based on recruitment period; no randomisation methods are used. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/02/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Adults aged ≥16 years 2. Diagnosis of breast, lung, colorectal or prostate cancer 3. Planned to commence first-line systemic anti-cancer therapy (SACT) 4. Able to provide written informed consent 5. ECOG performance status 0–1 6. Able to participate in a physical activity-based intervention |
| Key exclusion criteria | 1. Contraindications to exercise or physical activity, as identified by clinical assessment 2. Unstable or uncontrolled comorbidities that would preclude safe participation 3. Cognitive impairment or other factors preventing informed consent 4. Already participating in a structured prehabilitation or exercise programme |
| Date of first enrolment | 15/02/2026 |
| Date of final enrolment | 01/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
29/01/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).
