Prehabilitation and Supportive Care in Oncology Treatment of Breast Cancer (PROActive-B): a feasibility study of women with Breast cancer receiving neoadjuvant chemotherapy

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12622000584730
• Lead Sponsor: Chris O'Brien Lifehouse Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-20
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

Study participant Group 1:
1. Female, aged over 18 years, diagnosed with breast cancer.
2. Has been identified as a patient for the NACT pathway by treating breast surgeon and/or medical oncologist.
3. Willingness to provide written consent and able to complete written study assessments and understand instruction for program in English.
Study participant Group 2:
1. HCP participants who have been involved in the program delivery.

Exclusion Criteria

1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. Unable to give informed consent
3. Has completed more than 2 cycles of neoadjuvant chemotherapy at time of enrolment
4. Unable to participate due to no computer at home or device to teleconference.
5. Contraindications to participation will be determine based on oncologist and exercise physiologist review based on the PAR-Q and the Exercise and Sports Science Australia. The PAR-Q+ will be used as a preliminary tool. The PAR-Q+ is designed to identify symptoms or conditions requiring medical evaluation before participating in exercise. In this setting, cardiac risk is assessed to determine eligibility for NACT and medical records are reviewed before Exercise Physiology assessment. Additional information will be collected based on recommendations of Exercise and Sports Science Australia. These are outlined below:
•Health history
•physical activity and exercise history
•cancer and non-cancer co-morbidities
•expected treatment related toxicities
•identification of patient capacity and contraindications
•psychosocial and physiological constraints, accessibility, preferences, self-efficacy, barriers and facilitators to exercise
•patient-centred requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability and feasibility will be measured as a composite outcome using this set of four-item measures (Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM))[program completion (approx 20 weeks)];Recruitment rates determined by an audit of the study enrolment log.[Throughout the recruitment period]; Adherence to planned intervention rates determined by an audit of session attendance checklists.[At the end of the intervention]