A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation

NCT06772181 | Recruiting

• 2 other identifiers: RG1124991NCI-2024-10340
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial evaluates a digital health intervention for improving symptoms and physical activity among patients with breast cancer undergoing radiation. Cancer-related fatigue is common and strongly associated with quality of life during and after treatment. Increasing emphasis on early symptom detection and management has prompted initiatives to collect patient-reported fatigue from all patients during treatment. Mind-body interventions including physical activity and yoga are recommendations to treat fatigue and comorbid (coexisting) symptoms. Lower socioeconomic status has not only been associated with higher rates of physical inactivity but also with perceptions that it could negatively impact fatigue and quality of life during treatment. A virtual mind-body program called Integrative Medicine at Home (IM@Home) includes cardio fitness and yoga classes in a bundled intervention that has demonstrated decreased fatigue, depression, insomnia, and symptom distress among patients undergoing breast radiation. The IM@Home program may also increase physical activity among patients with breast cancer undergoing radiation.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Proportion of eligible patients that consent to the screening registry (Feasibility)

  Will be considered feasible, as designed, if over 50% of eligible patients consent to the screening registry. Will be determined using descriptive statistics.

  Up to 6 months

• Proportion of patients with fatigue or other comorbid symptoms enrolling to the Integrative Medicine at Home (IM@Home) virtual intervention (Acceptability)

  Will be considered acceptable if 50% of patients reporting fatigue or other comorbid symptoms agree to enroll to the IM@Home intervention. Will be determined using descriptive statistics.

  Up to 6 months

• Proportion of patients enrolling in IM@Home virtual intervention that report favorable implementation outcomes (Appropriateness)

  Will be assessed using a validated patient-reported outcomes (PRO) scale with responses as agree or completely agree. Will be determined using descriptive statistics.

  At 12 weeks

Secondary Outcomes (5)

• Proportion of participants meeting guideline recommendations for physical activity

  At baseline, 2, 4, 6, 8, 10, and 12 weeks

• Relationship between self-reported and monitor-based physical activity

  At baseline, 2, 4, 6, 8, 10, and 12 weeks

• Patient-reported fatigue

  At baseline, 2, 4, 6, 8, 10, and 12 weeks

• Sleep quality

  At baseline, 4, 8, and 12 weeks

• Social isolation

  At baseline, 6, and 12 weeks

Study Arms (2)

Intervention (IM@Home program)

EXPERIMENTAL

A subset of patients in the registry will participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.

Behavioral: IM@Home Program; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Interview

Registry (FitBit, PRO surveys)

EXPERIMENTAL

Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.

Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Interview

Interventions

Questionnaire Administration OTHER

Ancillary studies

Intervention (IM@Home program); Registry (FitBit, PRO surveys)

Interview OTHER

Ancillary studies

Intervention (IM@Home program); Registry (FitBit, PRO surveys)

IM@Home Program BEHAVIORAL

Participate in the IM@Home program delivered via Zoom

Intervention (IM@Home program)

Medical Device Usage and Evaluation OTHER

Wear a FitBit activity tracker

Intervention (IM@Home program); Registry (FitBit, PRO surveys)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• Ability to understand English, or has a caregiver who understands English.
• Ability to understand and willingness to sign a written informed consent document, virtually or in-person.
• Current breast cancer diagnosis.
• Currently receiving radiation with curative intent (including partial breast, whole breast, or regional nodal radiation).

You may not qualify if:

• Patients who are non-English speaking that would prevent their participation in IM@Home.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MultiCare Valley Hospital (Spokane)

Spokane Valley, Washington, 99216, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Erin Gillespie, MD, MPH

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Gillespie, MD, MPH

CONTACT

206-598-4100; efgillespie@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)