Supporting women to be active after breast cancer

ISRCTN	ISRCTN10275223
DOI	https://doi.org/10.1186/ISRCTN10275223
Integrated Research Application System (IRAS)	361493
Central Portfolio Management System (CPMS)	71188
Breast Cancer Now grant codes	2022.11PR1567
Sponsor	Newcastle University
Funder	Breast Cancer Now

Submission date: 01/12/2025
Registration date: 07/01/2026
Last edited: 07/01/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
More women are surviving breast cancer than ever before. But women often experience low mood, reduced strength and fitness, and extreme tiredness. These issues can last for years after treatment. Being active after breast cancer treatment can help. It can make women feel less tired, help them return to full strength, and improve their overall health and wellbeing. It may also lower the chances of cancer coming back. Unfortunately, most women do not get support to be active after treatment. The main issue is that there aren’t enough suitable physical activity classes for women to join. There are also no easy ways for healthcare professionals (such as breast care doctors and nurses) to refer women to classes. We have developed a programme called PURE-EX that allows women to be referred to suitable and supportive physical activity classes after their treatment.

This study aims to test the PURE-EX programme with 45 women who have completed surgery for breast cancer. We want to find out if they liked the programme, if it helped them, and how we can improve it. We also want to understand how the programme is viewed by the healthcare professionals and exercise instructors involved in delivering it.

Who can participate?
Women aged ≥18 years who have: i) received a clinical diagnosis of early-stage breast cancer (stage I-III); ii) completed surgery for breast cancer; and iii) received clearance from a treating clinician to participate in the study. Women must also be willing and able to provide written informed consent.

What does the study involve?
The study involves women being offered, and if they accept, participation in the following:
i. An exercise referral from a healthcare professional whilst attending a routine clinical appointment
ii. A one-to-one review with an exercise instructor
iii. A 12-week community-based group physical activity programme has been especially designed for women who have had breast cancer treatment, and which will be held in a location in the local community.

What are the possible benefits and risks of participating?
The study will find out if offering a referral to a community-based physical activity intervention, and participation in a 12-week community-based group exercise programme is feasible and acceptable to women who have had surgery for breast cancer.

Just like all forms of exercise, there is a small risk of tripping/falling or an adverse cardiovascular event during the exercise sessions. However, this type of exercise is considered extremely low risk and the exercise programme has been designed by a clinical exercise physiologist and a senior physiotherapist who have extensive experience of delivering safe exercise to cancer patients. All patients will be medically cleared to participate by their breast cancer team and will undergo a thorough screening process. Healthworks instructors, who will be delivering the exercise sessions, are also experienced in carrying out exercise sessions with people who have multiple long-term conditions.

Where is the study run from?
The Newcastle University, Newcastle upon Tyne, UK.

When is the study starting and how long is it expected to run for?
February 2026 to April 2027

Who is funding the study?
Breast Cancer Now

Who is the main contact?
Dr Morven Brown; morven.brown@newcastle.ac.uk

Contact information

Dr Morven Brown
Public, Scientific

Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

ORCID ID	0000-0003-2501-0670
Phone	+44 0191 282 1344
Email	morven.brown@newcastle.ac.uk

Prof Bernard Corfe
Principal investigator

Level 2, Room M2.051 William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

ORCID ID	0000-0003-0449-2228
Phone	+44 0191 208 1135
Email	bernard.corfe@newcastle.ac.uk

Dr Sam Orange
Scientific, Public

Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

ORCID ID	0000-0003-4734-1446
Email	sam.orange@newcastle.ac.uk

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Treatment
Participant information sheet	48588_PIS__v2_19Nov2025.pdf
Scientific title	Feasibility study: EXpanding into communities to imProve physical activity sUpport foR womEn after breast cancer (PURE-EX)
Study acronym	PURE-EX feasibility study v1.1
Study objectives	Study objectives To assess: i. The feasibility and acceptability of being offered referral to, and attending, a community-based physical activity programme in women who have completed surgery for breast cancer. ii. The feasibility and acceptability of breast cancer healthcare professionals offering physical activity referrals. iii. The feasibility, acceptability, and views of instructors delivering a community-based physical activity programme to women after breast cancer treatment. iv. The feasibility of data collection, measures of adherence and retention to the intervention. v. Potential signals of intervention efficacy.
Ethics approval(s)	Approved 27/11/2025, Wales Research Ethics Committee 3 (Health and Care Research Wales, Floor 4, Crown Building, Cardiff, CF10 3NQE, United Kingdom; -; Wales.REC3@wales.nhs.uk), ref: 25/WA/0330
Health condition(s) or problem(s) studied	Malignant neoplasm of breast
Intervention	This is a prospective, single-arm, pretest-posttest feasibility trial. The intervention that women will be invited to take part in consists of three main components: [1] An offer of exercise referral from a healthcare professional [2] A one-to-one review with an exercise instructor [3] A 12-week community-based group exercise programme THE PURE-EX INTERVENTION [1] An offer of exercise referral from a healthcare professional The referral offer (from a healthcare professional) is designed to be concise (30–60 seconds), addressing concerns about limited time and competing priorities. We envisage that the referral will most commonly be delivered by the treating surgeon in breast cancer clinics during a follow-up appointment approximately 2 weeks - 6 months post-surgery. At the breast cancer clinic, the healthcare professional will: • ASK about previous and current physical activity levels • ADVISE that being active after breast cancer surgery can reduce fatigue and other side effects (e.g., nerve pain), support physical and mental recovery, improve fitness for any planned treatments, and reduce recurrence risk by ~35% • ASSIST by: 1) Providing a brief information booklet on exercise after breast cancer (https://breastcancernow.org/download-and-order-publications/exer cises-after-breast-cancer-surgery-bcc6); 2) Recommending joining a local exercise class as one of the best ways to support recovery; 3) Asking whether the woman would like a free referral into a 12-week group exercise class with other women recovering from breast cancer surgery. If the woman agrees to the referral a research nurse, clinical team member, or clinical trials officer will complete a referral proforma including the woman’s contact details, preferred method of contact, and brief medical history (e.g., type of surgery, other treatments). The completed proforma will be securely sent (via post or secure email, depending on site preference) to a qualified exercise instructor at Healthworks, a community health charity in North East England (see below). The instructor will then contact the woman to arrange a one-to-one review before she joins the group class. If the woman declines the referral, the reason will be recorded on the screening log. [2] One-to-one review The one-to-one review will take place at the same location as the exercise class (Health Resource Centre, Adelaide Terrace, Newcastle upon Tyne, NE4 8BE). The instructor will collect background and medical information using a Case Report Form (CRF). The exercise instructor will then collect baseline data, including questionnaires and basic tests of cardiorespiratory fitness, strength and physical function. A wrist-worn accelerometer (for measurement of physical activity) to take home and return by post in a pre-paid envelope. [3] A community-based group exercise programme The group exercise programme will be delivered by the same Healthworks-employed instructor who conducted the one-to-one review. Participants will be invited to attend one class per week for 12 weeks. Each class will last 50 minutes and include up to 12 women, consisting of: 1. A brief welcome/introduction to any attendees 2. A 15-minute warm-up (pulse-raising activities, full-body stretches, arm/shoulder movements) 3. A 25-minute main session (aerobic, strength, and balance exercises) 4. A 10-minute cool-down (static stretches held for ~20 seconds at the point of slight discomfort) Exercises will be delivered in a circuit format: each movement performed for 60 seconds with ~15-second rest intervals, allowing participants to ready themselves for the next exercise in the sequence. Equipment will include dumbbells and resistance bands, and chair-based options will be available for those who need them. Throughout the 12-week programme, each participant will be provided with personalised recommendations and support for engaging in additional suitable physical activity (e.g., through local physical activity/exercise classes and groups; home-based exercises). The primary outcome of this study is the feasibility of the PURE-EX intervention. This will be assessed via the outcomes.
Intervention type	Behavioural
Primary outcome measure(s)	Acceptability of PURE-EX programme components measured using a validated acceptability questionnaire based on the theoretical framework of acceptability (TFA) at post-intervention Recruitment rate (the number of consenting participants divided by the number of women approached) measured using data collected from screening logs will document each woman who was approached and consented (and, if not consented, reasons why will be recorded where possible to enable identification of issues regarding feasibility/acceptability in those who decline) at one time point Participant acceptance of the physical activity referral (defined as whether the woman agrees for their contact details to be shared with the intervention provider) measured using data documented by the HCP at one time point Attendance at the community-based exercise programme and any adverse events measured using data recorded by the exercise instructor at one time point Adverse events and serious adverse events, as well as all non-serious adverse events that are deemed to be related to study participation measured using data collected in electronic Case Report Forms (eCRF) at one time point Experiences of participants, healthcare professionals and exercise instructors of taking part in, and delivering, the intervention measured using qualitative semi-structured interviews at post-intervention
Key secondary outcome measure(s)	Health-related quality of life measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) at baseline and post-intervention Fatigue assessed measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and post-intervention Anxiety and depression measured using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) at baseline and post-intervention Self-reported physical activity measured using the International Physical Activity Questionnaire – Short Form (IPAQ-SF) at baseline and post-intervention Participants engagement in health-promoting behaviours measured using the Health-Promoting Lifestyle Profile-II (HPLP-II) at baseline and post-intervention Cardiorespiratory fitness measured using the six-minute walk test (6MWT) at baseline and post-intervention Physical function measured using the Short Physical Performance Battery (SPPB), a composite measure of standing balance, five chair stands, and 4-meter gait speed at baseline and post-intervention Handgrip strength measured using a hand-held digital grip dynamometer – participants will use their dominant hand to squeeze at baseline and post-intervention Device-based physical activity measured using a tri-axial accelerometer (Axivity AX3, Axivity Ltd, Newcastle upon Tyne) at baseline and post-intervention
Completion date	01/05/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	120 Years
Sex	Female
Target sample size at registration	45
Key inclusion criteria	1. Women aged >= 18 years 2. Clinical diagnosis of early-stage locally advanced breast cancer (stage I-III) 3. Have completed surgery for breast cancer 4. Have received clearance from a treating clinician to participate in the study 5. Willing and able to provide written informed consent
Key exclusion criteria	1. Diagnosis of metastatic breast cancer (stage IV) 2. Currently undergoing chemotherapy or scheduled to start chemotherapy during the study period 3. Not sufficiently recovered from surgery in a manner that would contraindicate exercise, as determined by the treating clinician (e.g. inadequate wound healing, reduced range of motion, or other clinical concerns) 4. Musculoskeletal, neurological, or rheumatological condition that could be exacerbated by exercise, as determined by the treating clinician 5. Uncontrolled cardiovascular or metabolic disease 6. Pregnant or planning pregnancy during the study period
Date of first enrolment	02/02/2026
Date of final enrolment	31/12/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Queen Elizabeth Hospital (Lead)

Queen Elizabeth Avenue
Gateshead
NE9 6SX
England

Royal Victoria Infirmary

Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England

Healthworks Newcastle

Health Resource Centre
Adelaide Terrace
Newcastle upon Tyne
NE4 8BE
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request, Stored in publicly available repository
IPD sharing plan	• The quantitative datasets analysed during the current study will be stored in a publicly available repository (Open Science Framework; https://osf.io/) and will be made available within one month of publication in a peer-reviewed journal. Participants consented to the information collected about them to support other research in the future, and that it may be shared anonymously with other researchers. In line with Newcastle University guidance, research data will be stored for 10 years. • The qualitative datasets (interviews and focus groups) analysed during the current study will be available upon reasonable request from Professor Bernard Corfe; bernard.corfe; newcastle.ac.uk, this will be in the form of anonymised transcripts and will be available after publication of the datasets in a peer-reviewed journal. Participants consented to the information collected about them to support other research in the future, and that it may be shared anonymously with other researchers. Interview transcripts will be anonymised and any identifiable data removed. Participants will also be given study numbers/pseudonyms. In line with Newcastle University guidance, research data will be stored for 10 years.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 2	19/11/2025	12/12/2025	No	Yes
Protocol (preprint)		08/01/2025	12/12/2025	No	No
Protocol file	version 1.1	03/09/2025	12/12/2025	No	No

Additional files

48588_PIS__v2_19Nov2025.pdf: Participant information sheet
48588_Protocol_v1.1_03Sept2025.pdf: Protocol file

Editorial Notes

01/12/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).