Cardiac Rehabilitation for Breast Cancer Survivors

NCT06251401 | Recruiting

• 1 other identifier: 2022-0088-E
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Women with breast cancer treated using anthracyclines and/or trastuzumab are at an increased risk of cardiovascular disease (CVD) following treatment completion. Exercise is known to reduce CVD risk in healthy and several clinical populations, but, whether existing cardiac rehabilitation programs can be leveraged to reduce CVD risk in breast cancer survivors is unknown. This study aims to: i) understand the feasibility of virtual versus in-person cardiac rehabilitation in breast cancer survivors; and ii) compare the effect of virtual versus in-person cardiac rehabilitation on cardiovascular function and injury biomarkers, physical fitness, and psychosocial health. 50 breast cancer survivors with increased CVD risk will be recruited and randomized to either the in-person or virtual arm of the cardiac rehabilitation program at Women's College Hospital (WCH). Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility. Other clinically relevant outcomes to be collected include: i) imaging and blood-based biomarkers of cardiovascular function; ii) physical fitness; iii) objective and self-reported physical activity levels; and iv) self-reported measures of psychosocial wellbeing. These findings will be used to inform the design of a larger-scale cardio-oncology trial and will facilitate development of more comprehensive CVD risk management strategies for breast cancer survivors at WCH.

Conditions

Breast Cancer; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Defined as number of patients who agree to participate relative to the number of patients approached.

  1 week after study completion

• Intervention safety

  Data on all intervention-related adverse events (as defined by the Common Terminology Criteria for Adverse Events \[CTCAE\]) will be collected and reported according to CTCAE-defined categories. Non-trial related adverse events during the intervention period will also be recorded given that they may significantly impact participation.

  1 week post-intervention

• Study retention

  Retention will be assessed by measuring attrition throughout the intervention period.

  1 week post-intervention

• Reasons for drop-out

  Reasons for dropout and/or non-compliance to assessment protocols will also be collected.

  1 week post-intervention

• Intervention adherence

  Exercise adherence will be collected as relative dose intensity (RDI; exercise dose performed in each session relative to prescribed exercise dose).

  1 week post-intervention

• Participant satisfaction

  Satisfaction with the intervention and participant experiences will be collected via an investigator-created survey.

  1 week post-intervention

Secondary Outcomes (11)

• Estimated aerobic fitness

  2 weeks before starting cardiac rehabilitation and 1 week after completing cardiac rehabilitation

• Left ventricular ejection fraction (LVEF)

  2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

• Global longitudinal strain (GLS)

  2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

• E/A ratio

  2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

• Duke Activity Status Index

  2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

Study Arms (2)

In-person cardiac rehabilitation

EXPERIMENTAL

Those randomized to in-person cardiac rehabilitation group

Behavioral: In-person supervised cardiac rehabilitation

Virtual cardiac rehabilitation

EXPERIMENTAL

Those randomized to the virtual, home-based rehabilitation group

Behavioral: Virtual cardiac rehabilitation

Interventions

In-person supervised cardiac rehabilitation BEHAVIORAL

In-person CR consists of weekly group-based supervised exercise training at Women's College Hospital, supplemented with home-based exercise training, with the goal of reaching Canadian Physical Activity Guidelines of 150 minutes a week of moderate-intensity exercise per week. Exercise prescriptions are individualized at baseline by the cardiac rehabilitation team. Both study arms get have the opportunity to attend weekly synchronous virtual group video education sessions for the duration of the 12-week cardiac rehab program with the focus on self-management education and support.

In-person cardiac rehabilitation

Virtual cardiac rehabilitation BEHAVIORAL

Virtual CR consists of once-weekly telephone or video conferencing-based follow-ups (according to participant preference and access to internet/smart device) by one of the cardiac rehab providers. Similar to the in-person program, the virtual program also encourages participants to set goals to achieve 150 minutes a week of moderate-intensity exercise. The exercise prescription is individualized to each participant's ability and can vary in number of sessions per week and duration of each exercise session, as per the cardiac rehab provider's discretion. Unlike the in-person program, all these sessions are completed at home in an unsupervised manner. Both study arms get have the opportunity to attend weekly synchronous virtual group video education sessions for the duration of the 12-week cardiac rehab program with the focus on self-management education and support.

Virtual cardiac rehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 50 years
• previous receipt of anthracyclines and/or trastuzumab for breast cancer
• ability to participate in in-person cardiac rehabilitation

You may not qualify if:

• medical contraindications that preclude safe exercise participation17
• unwillingness to comply with study protocols.

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B3, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Husam Abdel-Qadir, MD-PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priya Brahmbhatt

CONTACT

416-323-6200; priya.brahmbhatt@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 9, 2024
• Study Start: March 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

CA (1)