Brief Summary

This clinical trial evaluates the feasibility of exercise during chemotherapy in older women with stage I-III breast cancer. Previous studies have reported that exercise may reduce the chemotherapy-toxicity risk. This trial may help researchers learn if engaging in a physical activity program is feasible in patients receiving chemotherapy for breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

8mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.1 years study duration

Study Progress89%

Dec 2020Dec 2026

Study Start

First participant enrolled

December 3, 2020

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed

10 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6.1 years

First QC Date

August 17, 2021

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

Adherence
Will be calculated as the ratios of (a) the average number of exercise sessions completed weekly to total number of weekly targeted sessions during the period of chemotherapy (goal = 5 for walking sessions and 2 for upper-extremity exercises wearable. The mean adherence will be calculated for each patient.
Up to 1 month after chemotherapy
Compliance
Compliance will be calculated as the ratio of the average total number of valid days (\>= 10 hours /day of use) to the total number of weekly targeted days (goal = 5). The mean compliance will be calculated for each patient.
Up to 1 month after chemotherapy
Retention
Will be assessed as the proportion of patients who enrolled in the study who complete all questionnaires and assessments at all time points.
Up to 1 month after chemotherapy

Secondary Outcomes (6)

Incidence of adverse events (AEs)
Up to 1 month after chemotherapy
Geriatric assessment
Baseline up to 1 month after chemotherapy
Short Physical Performance Battery (SPPB)
Baseline up to 1 month after chemotherapy
Quality of life questionnaires
Baseline up to 1 month after chemotherapy
Outcome Expectations for Exercise (OEE) Scale Questionnaires
Baseline up to 1 month after chemotherapy
+1 more secondary outcomes

Study Arms (1)

Supportive care (coaching, exercise, questionnaire)

EXPERIMENTAL

Patients participate in one-on-one coaching sessions with a health coach QW to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the WWE workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.

Procedure: DiscussionOther: Exercise InterventionOther: Informational InterventionOther: Medical Device Usage and EvaluationOther: Quality-of-Life AssessmentOther: Questionnaire Administration