Exercise referral to fitness centre or cardiac rehabilitation among breast cancer survivors

ISRCTN	ISRCTN11183372
DOI	https://doi.org/10.1186/ISRCTN11183372
Secondary identifying numbers	2014NovSP422

Submission date: 16/09/2015
Registration date: 04/02/2016
Last edited: 11/06/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Gill Hubbard
Public

Cancer Care Research Centre
School of Health Sciences
University of Stirling
Highland Campus
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Study information

Study design	Single-arm pilot feasibility trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Exercise referral to fitness centre or cardiac rehabilitation among breast cancer survivors: Pilot single-arm trial with embedded process evaluation
Study acronym	EFFECT
Study hypothesis	This study aims to evaluate the feasibility and acceptability of providing BCS with a choice of attending one of the following existing structured PA interventions - NHS cardiac rehabilitation and fitness/leisure centres for the general public.
Ethics approval(s)	North of Scotland Ethics Committee (1), 08/05/2015, ref: 15/NS/0036
Condition	Breast cancer
Intervention	Participants will be offered a choice of the two interventions: Cardiac Rehabilitation Phase III cardiac rehabilitation is usually a 10 to 12 week exercise programme delivered to patients within a traditional cardiac rehabilitation setting [31]. In the particular site where this study is being conducted, this will be a 10 week course, with a 60 minute exercise class once a week. The programme will be delivered by a cardiac physiotherapist, and is supported by a cardiac nurse co-ordinator, and a physiotherapy assistant. Exercise will be tailored to the individual during an initial assessment with the physiotherapist. Participants will be given individual activity goals, and appropriate intensities for activities. Exercise will take place in a group setting, and will include both cancer and cardiac patients. Lower intensity classes will be available, if required. Educational components will form part of the programme, and include general health advice (e.g. diet, exercise, relaxation), alongside cardiac specific sessions (e.g. medications). Attendance will be recorded. Fitness centre Participants will be referred to an instructor who is qualified to Register of Exercise Professionals (REPs) Level 4, in Cancer and Exercise. Exercise will take place in a gym setting, or in a class setting (if appropriate), alongside members of the general public. An individual exercise programme will be set up between the participant and the specialist instructor during a one-to-one appointment. For the purpose of the study, participants will be provided with a 3-month free membership card, giving them free access to a range of fitness classes, gym and swimming pool. Advice will be offered on an individual basis on the safety of use for each participant. Participants will be able to visit the facility as often as they wish during the 3 month period. Attendance will be recorded. Follow up: Participants will complete repeated measures on completion of the intervention of their choice. This will involve completion of the questionnaire (as done at baseline), and a semi-structured interview.
Intervention type	Behavioural
Primary outcome measure	Physical Activity and sedentary behaviour is measured using an accelerometer, the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ), a physical activity self-efficacy self-report questionnaire and analysing an activity diary at baseline and the end of the intervention.
Secondary outcome measures	1. Quality of life is measured using the EQ-5D questionnaire and the Functional Assessment of Cancer Therapy for Breast cancer (FACT-B) questionnaire at baseline and the end of the intervention 2. Fatigue is measured using an additional questions in the FACT-B questionnaire at baseline and the end of the intervention 3. Functional strength is measured using the five repetition sit to stand test at baseline and the end of the intervention 4. Confounding/mediating factors are determined using patient records at baseline and the end of the intervention
Overall study start date	01/06/2015
Overall study end date	30/04/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	12
Participant inclusion criteria	1. Are aged 16 years of age or over 2. Diagnosed with breast cancer (any stage) or Ductal Carcinoma In-Situ (DCIS) having surgery, axillary surgery, or undergoing risk-reducing mastectomy 2. Post-surgery and may (or may not) be having adjuvant therapy (chemotherapy and/or radiotherapy) and may have had neoadjuvant therapy before surgery No longer appliable as of 25/07/2016: 3. Live within a 35-mile radius of cardiac rehabilitation/fitness centre
Participant exclusion criteria	1. A clinician (e.g. consultant or clinical nurse specialist) decides that they are unsuitable for inclusion 2. A clinician decides that the BCS has a cognitive impairment and thereby cannot give informed consent 3. Scheduled to have further surgery in the next 12 weeks
Recruitment start date	01/09/2016
Recruitment end date	30/11/2016

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Raigmore Hospital

NHS Highland
Old Perth Rd
Inverness
IV2 3UJ
United Kingdom

Sponsor information

University of Stirling
Charity

Research and Enterprise Office
3B1 Cottrell Building
University of Stirling
FK9 4LA
Stirling
FK9 4LA
United Kingdom

"ROR"	https://ror.org/045wgfr59

Funders

Funder type

Charity

Breast Cancer Now

No information available

Results and Publications

Intention to publish date	01/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Plan to publish the study protocol in a peer reviewed journal. Findings will also be shared with the Breast Cancer charity who fund the study (Breast Cancer Now), and the wider breast cancer community. Study findings will also be submitted for review and publication in a suitable peer reviewed journal and possibly at Local and National conferences.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2018		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

11/06/2018: PubMed link added.
04/06/2018: Publication reference added.
25/07/2016: The target number of participants has been updated from 20 to 12 and the inclusion criteria have been updated. Additionally, the overall trial end date has been updated from 31/05/2016 to 30/04/2017, and the recruitment dates have been updated from 01/06/2015 - 31/12/2015 to 01/09/2016 - 30/11/2016
19/05/2016: Internal review.