Digital Health Intervention for Breast Cancer

(PRO-ACTIVE Trial)

Recruiting at 1 trial location

Overseen By Erin Gillespie, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Non-English speaking, Metastatic disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a digital health intervention for breast cancer patients undergoing radiation.

What data supports the effectiveness of the treatment Integrative Medicine at Home (IM@Home) for breast cancer?

Research shows that integrative medicine, which combines therapies like nutrition, exercise, and mind-body practices, can improve cancer outcomes by targeting various aspects of the disease and enhancing quality of life. These approaches have been shown to help manage symptoms and improve well-being in cancer patients. ^{1 2 3 4 5}

Is the digital health intervention for breast cancer safe?

There is limited safety data on complementary and alternative medicine (CAM) for cancer patients, and while many patients use these therapies, there are concerns about potential interactions with cancer treatments. It's important to discuss any CAM use with healthcare providers to ensure safety. ^{6 7 8 9 10}

How is the Integrative Medicine at Home (IM@Home) treatment for breast cancer unique?

The Integrative Medicine at Home (IM@Home) treatment is unique because it combines digital health technologies with self-care practices like mindfulness, yoga, and lifestyle modifications to support breast cancer treatment. This approach empowers patients by integrating non-drug interventions with traditional therapies, potentially improving quality of life and treatment adherence. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Erin Gillespie, MD, MPH

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for patients with breast cancer, including Ductal Carcinoma In Situ and Lobular Carcinoma in Situ, who are undergoing radiation therapy. It aims to help those experiencing fatigue and looking to improve their quality of life during treatment.

Inclusion Criteria

I have been diagnosed with breast cancer.

Ability to understand and willingness to sign a written informed consent document, virtually or in-person

I am currently undergoing radiation therapy aimed at curing my cancer.

Exclusion Criteria

My cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 months

Registry

Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy.

12 weeks

Bi-weekly virtual check-ins

Intervention

Patients participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes delivered via Zoom. Patients are instructed to complete at least 3 classes per week for 12 weeks.

12 weeks

3 virtual classes per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of physical activity, fatigue, sleep quality, and social isolation.

4 weeks

Treatment Details

Interventions

• Integrative Medicine at Home (IM@Home)

Trial Overview The study tests a digital health program called IM@Home that offers mind-body interventions like cardio fitness, yoga, Tai Chi, Qigong, dance cardio, guided meditation, music therapy along with questionnaire feedback and medical device evaluation.

Participant Groups

Group I: Registry (FitBit, PRO surveys) Experimental Treatment 2 Interventions

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.

Group II: Intervention (IM@Home program) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

Integrative medicine for cancer patients combines various therapeutic approaches, including nutritional counseling, physical activity, and dietary supplements, which may improve cancer outcomes by targeting multiple cancer hallmarks.

This comprehensive approach can influence key processes like genetic instability and immune system evasion, suggesting that lifestyle and dietary changes could play a significant role in cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative therapies in cancer: modulating a broad spectrum of targets for cancer management. Block, KI., Block, PB., Gyllenhaal, C.[2019]

Integrative oncology combines complementary therapies with conventional medical treatments to enhance efficacy, improve symptom control, and reduce patient distress, reflecting a growing demand for holistic cancer care.

Current research in integrative oncology is focused on evaluating the effectiveness of various complementary therapies, such as natural health products and mind-body approaches, through randomized controlled trials to establish evidence-based practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative oncology in North America. Sagar, SM.[2022]

A complementary/integrative medicine (CIM) program significantly improved quality of life for patients with breast and gynecologic cancers, reducing fatigue, depression, and enhancing overall well-being before their first chemotherapy cycle.

Out of 55 patients, those who participated in CIM treatments reported less anxiety and better emotional health compared to those who received only standard supportive care, highlighting the potential benefits of integrating CIM into cancer treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing integrative care in the pre-chemotherapy setting: a pragmatic controlled patient-centered trial with implications for supportive cancer care. Ben-Arye, E., Dahly, H., Keshet, Y., et al.[2018]

Integrative oncology uses evidence-based complementary therapies to effectively manage physical and emotional symptoms in cancer patients, enhancing their overall strength and quality of life during and after treatment.

Unlike alternative therapies, which often lack scientific support and can be misleading, complementary therapies are safe, noninvasive, and have demonstrated benefits, making them valuable adjuncts to mainstream cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative oncology: an overview. Deng, G., Cassileth, B.[2018]

Integrative oncology offers a promising approach to combine traditional, complementary, and integrative medicine (TCIM) with conventional cancer treatments, particularly in low- and middle-income countries where access to evidence-based care is limited.

The review emphasizes the importance of educating TCIM providers, developing targeted interventions for cancer symptoms, and implementing evidence-based TCIM practices to enhance patient-centered care and improve quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative oncology: Addressing the global challenges of cancer prevention and treatment. Mao, JJ., Pillai, GG., Andrade, CJ., et al.[2022]

In a study involving 82 advanced cancer patients across four oncology clinics, 34% of routine visits included discussions about complementary and integrative medicine (CIM), primarily initiated by patients (76%).

Providers' responses to CIM mentions significantly influenced the conversation, with 44% of responses inhibiting further discussion, while 56% encouraged it, highlighting the importance of provider engagement in discussing treatment options that align with patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory typology of provider responses that encourage and discourage conversation about complementary and integrative medicine during routine oncology visits. Koenig, CJ., Ho, EY., Trupin, L., et al.[2019]

In a study of 1,000 women diagnosed with breast cancer, 96.5% reported using at least one form of complementary and alternative medicine (CAM) prior to their diagnosis, indicating a high prevalence of CAM use among this population.

After diagnosis, 86.1% of participants continued to use CAM, with common practices including botanical supplements, mind-body healing, and special diets, highlighting the importance for healthcare providers to discuss CAM options with breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapy use before and after breast cancer diagnosis: the Pathways Study. Greenlee, H., Kwan, ML., Ergas, IJ., et al.[2022]

Approximately 40% of cancer patients in Western countries use complementary and alternative medicine (CAM), with usage rates as high as 80% among breast cancer patients, primarily to enhance immune function and improve quality of life.

Despite the popularity of CAM, many treatments lack solid scientific evidence for their safety and efficacy, and self-prescribing can lead to harmful drug interactions that may reduce the effectiveness of conventional cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Concomitant Use of Anticancer Drugs and Herbal Products: From Interactions to Synergic Activity. Berretta, M., Dal Lago, L., Tinazzi, M., et al.[2023]

In a study of 75 breast cancer patients over 15 months, 76.7% of those seeking to reduce side effects from conventional treatment reported success with integrative medicine approaches.

82% of patients aiming to improve their quality of life achieved their goal, particularly those with a good treatment prognosis, highlighting the potential benefits of integrating complementary therapies into standard cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported Improvement in Side Effects and Quality of Life With Integrative Medicine in Breast Cancer Patients. Hack, CC., Hackl, J., Hüttner, NBM., et al.[2019]

A significant number of US cancer patients, ranging from 9% to 91%, utilize complementary and alternative medicine (CAM) therapies after their diagnosis, highlighting the widespread interest in these approaches.

There is a lack of sufficient data on the efficacy and safety of CAM therapies, prompting the National Cancer Institute (NCI) to enhance research and improve the quality of information regarding CAM in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicine research: a National Cancer Institute perspective. White, JD.[2007]

E-health based self-management programs significantly reduce cancer-related fatigue (CRF) and improve self-efficacy among adult cancer patients, based on a systematic review of 15 trials involving 2,337 participants.

However, these e-health interventions did not show a statistically significant improvement in quality of life (QOL), indicating that while they help with fatigue and self-confidence, they may not enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of e-health based self-management to improve cancer-related fatigue, self-efficacy and quality of life in cancer patients: Systematic review and meta-analysis. Xu, A., Wang, Y., Wu, X.[2020]

Combining pharmaceutical drugs with digital health technologies, like mobile apps, can enhance treatment for chronic diseases by improving medication adherence and offering personalized self-care strategies.

Digital therapies can support traditional treatments for conditions such as epilepsy, chronic pain, and depression, by integrating lifestyle modifications and self-care practices tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Precision Metapharmacology to Patient Empowerment: Delivery of Self-Care Practices for Epilepsy, Pain, Depression and Cancer Using Digital Health Technologies. Bulaj, G., Clark, J., Ebrahimi, M., et al.[2021]

A 4-week trial involving 30 cancer patients showed that a digital therapeutic program delivered via a smartphone app was highly engaging, with 97% of participants active for at least 3 weeks and an average of 7.7 interactions per day.

Participants reported high satisfaction with the program, with 89% likely to recommend it, and while quality of life remained stable, 50% experienced less pain, indicating potential benefits of lifestyle interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. Gudmundsson, GH., Mészáros, J., Björnsdóttir, ÁE., et al.[2022]

The My Journey online program, designed to improve adherence to oral endocrine therapy in breast cancer survivors, received positive usability feedback from 15 participants, indicating it is user-friendly and well-received.

A randomized feasibility trial is underway with 80 participants to further evaluate the effectiveness of My Journey compared to a health education program, highlighting its potential role in enhancing cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and usability findings of an e-health intervention to improve oral anticancer adherence among breast cancer survivors: The My Journey mindfulness study. Yanez, B., Oswald, LB., Van Denburg, AN., et al.[2023]

Mobile health interventions have the potential to improve lifestyle behaviors among cancer survivors, but current evidence is insufficient in quality and rigor to make definitive recommendations.

Only a small number of studies (19 articles) were reviewed, with low overall study quality and limited use of theoretical frameworks in app design, highlighting the need for more robust research before these interventions can be safely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Applications, Cancer Survivors, and Lifestyle Modification: An Integrative Review. Kelley, MM., Kue, J., Brophy, L., et al.[2023]

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Integrative therapies in cancer: modulating a broad spectrum of targets for cancer management. [2019]

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Integrative oncology in North America. [2022]

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Providing integrative care in the pre-chemotherapy setting: a pragmatic controlled patient-centered trial with implications for supportive cancer care. [2018]

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Integrative oncology: an overview. [2018]

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Integrative oncology: Addressing the global challenges of cancer prevention and treatment. [2022]

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An exploratory typology of provider responses that encourage and discourage conversation about complementary and integrative medicine during routine oncology visits. [2019]

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Complementary and alternative therapy use before and after breast cancer diagnosis: the Pathways Study. [2022]

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Evaluation of Concomitant Use of Anticancer Drugs and Herbal Products: From Interactions to Synergic Activity. [2023]

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Self-reported Improvement in Side Effects and Quality of Life With Integrative Medicine in Breast Cancer Patients. [2019]

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Complementary and alternative medicine research: a National Cancer Institute perspective. [2007]

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Effectiveness of e-health based self-management to improve cancer-related fatigue, self-efficacy and quality of life in cancer patients: Systematic review and meta-analysis. [2020]

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From Precision Metapharmacology to Patient Empowerment: Delivery of Self-Care Practices for Epilepsy, Pain, Depression and Cancer Using Digital Health Technologies. [2021]

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Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. [2022]

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