Breast CarcinomaPRO-ACTIVENCT06772181
A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation
A study testing IM@Home Program, Medical Device Usage and Evaluation and Questionnaire Administration in people with Breast Carcinoma, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- IM@Home Program, Medical Device Usage and Evaluation and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients who are non-English speaking that would prevent their participation in IM@Home.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
MultiCare Valley Hospital (Spokane)
Spokane Valley, Washington, 99216
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Breast Carcinoma
- Being tested
- IM@Home Program, Medical Device Usage and Evaluation, Questionnaire Administration, Interview
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM@Home ProgramBehavioural
Participate in the IM@Home program delivered via Zoom
Medical Device Usage and EvaluationOther
Wear a FitBit activity tracker
Questionnaire AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 12 weeks
Secondary outcomes (5)
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.
Measured: At baseline, 2, 4, 6, 8, 10, and 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start4 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Gillespie, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772181
- Sponsor's protocol ID
- RG1124991
- Other IDs
- NCI-2024-10340
- Acronym
- PRO-ACTIVE
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06772181
- Acronym / sponsor ID
- PRO-ACTIVE / RG1124991
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (IM@Home program) | Experimental | Behavioral: IM@Home Program, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Other: InterviewA 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 | Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Other: InterviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who are non-English speaking that would prevent their participation in IM@Home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IM@Home ProgramParticipate in the IM@Home program delivered via Zoom | Behavioural | Intervention (IM@Home program) |
| Medical Device Usage and EvaluationWear a FitBit activity tracker | Other | Intervention (IM@Home program), Registry (FitBit, PRO surveys) |
| Questionnaire AdministrationAncillary studies | Other | Intervention (IM@Home program), Registry (FitBit, PRO surveys) |
| InterviewAncillary studies | Other | Intervention (IM@Home program), Registry (FitBit, PRO surveys) |
Primary outcome
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.
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.
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.
5 secondary outcomes
Proportion of participants meeting guideline recommendations for physical activity
Time frame: At baseline, 2, 4, 6, 8, 10, and 12 weeks
Relationship between self-reported and monitor-based physical activity
Time frame: At baseline, 2, 4, 6, 8, 10, and 12 weeks
Patient-reported fatigue
Time frame: At baseline, 2, 4, 6, 8, 10, and 12 weeks
Sleep quality
Time frame: At baseline, 4, 8, and 12 weeks
Social isolation
Time frame: At baseline, 6, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Gillespie, MD, MPH principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IM@Home Program, Medical Device Usage and Evaluation and Questionnaire Administration in people with Breast Carcinoma, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients that consent to the screening registry (Feasibility) (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.