Move to Improve: Investigating the Feasibility of Embedding Physical Activity Into Routine Breast Cancer Care in Indonesia
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gadjah Mada University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Physical fitness
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Physical activity intervention
Intervention: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands (Behavioral)
Outcomes
Primary Outcomes
Physical fitness
Time Frame: Baseline and post-intervention (12 weeks)
Physical fitness was measured using a submaximal treadmill test with the modified Bruce protocol. Treadmill speed and inclination were automatically increased every 3 min (test stage). The test was terminated when participants reached volitional fatigue. Physical fitness was classified as low, fair, average, and good, based on patients' age, treadmill test duration, and predicted VO2peak.
Fatigue
Time Frame: Baseline and post-intervention (12 weeks)
Fatigue was assessed using the Indonesian version of Fatigue Severity Scale (FSS). A higher score on the FSS indicated a more severe level of fatigue. The FSS was also classified as no-to-mild fatigue (FSS \<4.0) and severe fatigue (≥4.0).
Health-related quality of life
Time Frame: Baseline and post-intervention (12 weeks)
Health-related quality of life was assessed using the Indonesian version of the EORTC Quality of Life Questionnaire (QLQ-C30). The EORTC QLQ-C30 consists of global health status, functional scales, and symptom scales. A higher score indicates better health for global health status and functional scales, but represents a higher level of burden for symptom scales.
Secondary Outcomes
- Inflammatory biomarkers(Baseline and post-intervention (12 weeks))
- Intervention acceptability(Post-intervention (12 weeks))
- Intervention barriers and facilitators(Post-intervention (12 weeks))
Investigators
Susanna Hilda Hutajulu
Susanna Hilda Hutajulu, MD, PhD
Gadjah Mada University