Feasibility and Effects of Home-based Physical Activity Intervention in Patients With Breast Cancer in Indonesia

Gadjah Mada University

Status: Completed

Conditions: Physical Fitness; Breast Neoplasms

Treatments: Behavioral: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands

Study type: Interventional

Funder types: Other

Identifiers

NCT07338903

3550/UN1.P.III/DitLit/PT.01.05

Details and patient eligibility

About

The goal of this clinical trial is to learn the impact and implementation of home-based aerobic and resistance training for patients with breast cancer in Indonesia. The main questions it aims to answer are:

• Does the home-based aerobic and resistance training improve physical fitness, fatigue, and quality of life of patients with breast cancer?
• Are the benefits of aerobic and resistance training mediated by inflammatory level changes?
• What are the barriers and facilitators in implementing the home-based aerobic and resistance training?
• Is the home-based aerobic and resistance training feasible to be implemented in Indonesia's setting?

To answer those questions, participants will:

• Conduct home-based aerobic and resistance training with supervision.
• Visit the hospital once every 4 weeks for their routine visits.
• Undergo physical fitness test before and after 12 weeks using treadmill test, as well as interviews to assess fatigue, quality of life, and intervention acceptability.
• Keep a diary to record the aerobic and resistance training at home.
• Undergo routine monitoring by phone every week with the research team.

Enrollment: 36 patients

Sex: Female

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with stage I-III hormone-receptor positive breast cancer
• Eastern Cooperative Oncology Group (ECOG) score ≤1
• Had completed primary treatment (e.g., surgery, chemotherapy, and radiotherapy), except for hormonal treatment
• Within 5 years of diagnosis
• Able to perform moderate-intensity physical activity as determined by their oncologist and care team
• Able to read and write in Indonesian
• Willing to provide written informed consent.

Exclusion criteria

• Had an ejection fraction of <50%
• Evidence of cardiac disease, severe musculoskeletal problems, or other contraindications for exercise.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Physical activity intervention

Experimental group

Treatment:

Behavioral: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands