Condition category
Cancer
Date applied
16/09/2015
Date assigned
04/02/2016
Last edited
25/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Public

Primary contact

Dr Gill Hubbard

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2014NovSP422

Study information

Scientific title

Exercise referral to fitness centre or cardiac rehabilitation among breast cancer survivors: Pilot single-arm trial with embedded process evaluation

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

North of Scotland Ethics Committee (1), 08/05/2015, ref: 15/NS/0036

Study design

Single-arm pilot feasibility trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2015

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

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

United Kingdom

Trial participating centre

Raigmore Hospital
NHS Highland Old Perth Rd
Inverness
IV2 3UJ
United Kingdom

Sponsor information

Organisation

University of Stirling

Sponsor details

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

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Breast Cancer Now

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/12/2015

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.