A feasibility study evaluating a structured telehealth Lifestyle intervention (Exercise And Diet) for early-stage Breast Cancer Survivors (LEAD-4-BCS) undergoing neo-adjuvant/ adjuvant chemotherapy

Not Applicable

• Conditions: Breast cancer; physical inactivity; weight gain; Cancer - Breast; Diet and Nutrition - Obesity; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12622000741785
• Lead Sponsor: Faculty of Medicine and Health, University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adults aged 18 years and over with early-stage breast cancer diagnosis who are to be treated with chemotherapy for curative intent (neo-adjuvant or adjuvant);
-Have a minimum of 12 weeks of chemotherapy remaining to allow study participation;
-Not on a special diet for medical reasons that contradicts high fibre, low fat dietary recommendations;
-No known comorbidities limiting exercise (e.g. uncontrolled blood sugar level, blood pressure, etc). Medical clearance is needed if unable to pass exercise and fall risk screening questions;
-Have valid email address and able to use it to access materials/web links for questionnaire and zoom links. If participants have no active email address but willing to create one for the study they will be eligible;
-Have access to a device that enables access to a virtual platform (e.g, Zoom) to participate in exercise and dietary session;
-Willing and able to comply with all study requirements, timing and/or nature of required assessments;
-Fluent in English.

Exclusion Criteria

-Fall risk without medical clearance
-Cognitively impaired or unable to give informed consent;
-Visual impairment affecting ability to follow instructions on screen to exercise safely;
-Other advanced stage of malignancy;
-Concurrent illness requiring high dose steroids (e.g. 25mg Prednisolone (or equivalent);
-Presence of any psychological, familial, sociological or comorbidities potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence, drug abuse, eating disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is a composite primary outcome from participants’ adherence rate (self-reported) to exercise and diet prescriptions. Food and exercise diary (daily reporting but adherence score check at 4-week intervals) will be used to determine adherence rate. <br>For example, participant A has been given the exercise prescription of 90mins of exercise per week (60mins of group exercise session and a 30min walk) and dietary prescription of 2 pieces of fruit with 3 serves of vegetables per day for the first 4 weeks. Participant A's diary indicating participant's average weekly exercise and daily intake of fruit and vegetables will be used to calculate adherence rate.<br><br>[Post study intervention assessment will be conducted on week 16 +/- 1 week (or within 3 weeks of last intervention session).]