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NCT Number: NCT06772181

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

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About this study

OUTLINE:

REGISTRY: 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.

INTERVENTION: Patients 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

IM@Home Program

Behavioral

Participate in the IM@Home program delivered via Zoom

Medical Device Usage and Evaluation

Other

Wear a FitBit activity tracker

Questionnaire Administration

Other

Ancillary studies

interview

Other

Ancillary studies

Primary outcomes

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

    Time frame: Up to 6 months

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

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

    Time frame: Up to 6 months

    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.

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

    Time frame: At 12 weeks

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

Secondary outcomes

  1. Proportion of participants meeting guideline recommendations for physical activity

    Time frame: At baseline, 2, 4, 6, 8, 10, and 12 weeks

    Will be assessed using the Godin Leisure Time Exercise Questionnaire. Will be estimated, along with an exact binomial 95% confidence interval, though no formal statistical testing will be performed.

  2. Relationship between self-reported and monitor-based physical activity

    Time frame: At baseline, 2, 4, 6, 8, 10, and 12 weeks

    Will be evaluated graphically via a scatterplot and Bland-Altman plot. Pearson's correlation coefficient will be estimated for descriptive purposes.

  3. Patient-reported fatigue

    Time frame: At baseline, 2, 4, 6, 8, 10, and 12 weeks

    Will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Will be plotted graphically for all patients, showing those participating in IM@Home compared to those not assigned to IM@Home.

  4. Sleep quality

    Time frame: At baseline, 4, 8, and 12 weeks

    Will be assessed using the Insomnia Severity Index. Paired T-tests will be assessed for significant within-patient differences in insomnia.

  5. Social isolation

    Time frame: At baseline, 6, and 12 weeks

    Will be assessed using the Cancer Loneliness Scale. Paired T-tests will be assessed for significant within-patient differences in social isolation.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Multicenter Pilot Study: Leveraging Digital Health to Promote Evidence-Based Physical Activity to Improve Symptoms Among Patients Undergoing Radiation for Breast Cancer (PRO-ACTIVE)

Acronym: PRO-ACTIVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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