Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10340 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM@Home Program | Behavioral | Participate in the IM@Home program delivered via Zoom |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants meeting guideline recommendations for physical activity | 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. | At baseline, 2, 4, 6, 8, 10, and 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erin Gillespie, MD, MPH | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States | ||
| MultiCare Valley Hospital (Spokane) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2025 | May 20, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Medical Device Usage and Evaluation | Other | Wear a FitBit activity tracker |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Interview | Other | Ancillary studies |
|
| Relationship between self-reported and monitor-based physical activity |
Will be evaluated graphically via a scatterplot and Bland-Altman plot. Pearson's correlation coefficient will be estimated for descriptive purposes. |
| At baseline, 2, 4, 6, 8, 10, and 12 weeks |
| Patient-reported fatigue | 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. | At baseline, 2, 4, 6, 8, 10, and 12 weeks |
| Sleep quality | Will be assessed using the Insomnia Severity Index. Paired T-tests will be assessed for significant within-patient differences in insomnia. | At baseline, 4, 8, and 12 weeks |
| Social isolation | Will be assessed using the Cancer Loneliness Scale. Paired T-tests will be assessed for significant within-patient differences in social isolation. | At baseline, 6, and 12 weeks |
| Spokane Valley |
| Washington |
| 99216 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |