Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy

NCT05254678 | Completed

• 1 other identifier: HREBA.CC-21-0429
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine the feasibility of our proposed intervention approach involving (1) an integrated physiotherapy and exercise intervention for individuals with breast cancer who are undergoing chemotherapy and (2) delivery of programming via an electronic health (eHealth) application. The secondary objective is to determine the efficacy of the program on upper extremity outcomes, general physical fitness, cancer treatment-related symptoms and quality of life.

Conditions

Breast Cancer; Upper Extremity Dysfunction

Keywords

exercise; physical therapy; eHealth

Outcome Measures

Primary Outcomes (1)

• Completion rate

  Defined as \>70% participants completing at least 70% of exercise sessions and the post-study assessment

  10 weeks

Secondary Outcomes (20)

• Recruitment rate

  one year

• Attendance rate

  10 weeks

• Program Satisfaction

  10 weeks

• Symptoms

  10 weeks

• Health-related Quality of Life

  10 weeks

Other Outcomes (2)

• Grip strength (optional)

  10 weeks

• Core muscular endurance (optional)

  10 weeks

Study Arms (2)

Standard exercise program

ACTIVE COMPARATOR

Participants in this group will take part the general exercise program delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application.

Behavioral: general exercise

Integrated physiotherapy and exercise

EXPERIMENTAL

Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules.

Behavioral: general exercise

Interventions

general exercise BEHAVIORAL

A 10-week integrated physiotherapy and general exercise intervention compared to a general exercise intervention alone.

Also known as: physiotherapy

Integrated physiotherapy and exercise; Standard exercise program

Eligibility Criteria

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

You may qualify if:

• adult females with a diagnosis of breast cancer (Stage Ic-III);
• be able to participate in mild levels of activity at minimum;
• have completed cancer surgery involving a mastectomy or breast conserving surgery involving either an axillary lymph node dissection or sentinel lymph node biopsy;
• having completed or undergoing adjuvant chemotherapy +/- biological therapy treatment (eligible from 4 weeks to one year post-surgery at baseline);
• speak and understand English.

You may not qualify if:

• unable to commit to the 10-week virtual program including testing sessions at the Cancer Rehabilitation clinic in the Corbett Hall at the University of Alberta;
• do not have regular access to the internet and a smart device or computer in the home.
• are scheduled to undergo neoadjuvant chemotherapy

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Margaret McNeely

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent assessors will be used for collection of objective outcomes. The independent assessors will be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled feasibility trial

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: September 20, 2023
• Primary Completion: February 6, 2024
• Study Completion: December 30, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When study findings have been published
• Access Criteria: The data on repository will be available on request to the principal investigator.

Locations

CA (1)