Integrative Medicine at Home (IM@Home) for Cancer

(IMPROVE Trial)

Recruiting at 6 trial locations

Overseen By Michael Postow, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Cognitive impairment, Unwilling to accept randomization, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual mind-body program called Integrative Medicine at Home (IM@Home) can improve cancer treatment experiences for patients. It includes two groups: one receiving IM@Home and the other receiving enhanced usual care, which involves remote foot temperature monitoring using the Podimetrics SmartMat. Individuals with certain types of cancer, such as breast, lung, or ovarian, who are currently undergoing treatment or have recently completed specific treatments, may be suitable candidates. Participants should have experienced significant fatigue recently. The goal is to enhance how patients feel and manage their treatment journey. As an unphased trial, this study provides a unique opportunity to explore innovative care options that may enhance the treatment experience.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, as the trial is for patients actively receiving cancer treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Integrative Medicine at Home (IM@Home) program is generally safe for patients. In past studies, participants in this virtual mind-body fitness program had fewer hospital visits and required less emergency care, suggesting the program does not cause serious side effects. IM@Home aims to help cancer patients manage symptoms like tiredness, pain, and sleep problems. To date, no serious problems have been reported in connection with the program. Overall, these findings indicate a safe experience for prospective participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrative Medicine at Home (IM@Home) approach for cancer because it offers a unique blend of integrative therapies delivered directly to patients in the comfort of their own homes. Unlike standard treatments for cancers like head and neck tumors, thoracic tumors, and others, which often require frequent hospital visits, IM@Home aims to enhance quality of life by incorporating personalized care plans that include complementary therapies such as nutrition counseling, stress management, and physical activity. This approach not only reduces the burden of travel for patients but also addresses the holistic needs of individuals, potentially leading to improved outcomes and overall well-being.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that the Integrative Medicine at Home (IM@Home) program, one of the treatment arms in this trial, offers promising benefits for people with cancer. One study found that patients using this online mind-body program needed fewer emergency visits and spent less time in the hospital. Another study reported better patient outcomes and experiences during cancer treatment. These findings suggest that IM@Home can support patients' well-being during treatments like chemotherapy or radiotherapy. Overall, early evidence indicates positive effects on reducing stress and improving the quality of life for cancer patients. Participants in this trial may receive either the IM@Home program or enhanced usual care, which serves as another treatment arm. ^{1 2 4 6 7}

Who Is on the Research Team?

Karolina Bryl, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain cancers (like head and neck, lung, gynecologic, or melanoma) who are currently undergoing treatment or have recently finished radiotherapy. They should be experiencing fatigue and have a life expectancy of more than six months. Participants must speak English and not have cognitive impairments that affect communication.

Inclusion Criteria

I have experienced significant fatigue, rating it 4 or higher in the past week.

I have been diagnosed with cancer in my head, neck, chest, reproductive organs, skin, or breast.

I am currently undergoing cancer treatment or finished radiotherapy within the last 4 weeks.

Exclusion Criteria

I am mentally capable of understanding and responding to study assessments without needing a legal representative.

I am not enrolled in any other trials focusing on symptom management with integrative medicine.

I am not open to being randomly assigned to a treatment group.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo systemic cancer treatment such as chemotherapy, immunotherapy, radiotherapy, targeted agents, cytoreductive surgery, and participate in the IM@Home virtual mind-body program

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• IM@Home

Trial Overview The study is testing the IM@Home program to see if it can ease symptoms like tiredness, pain, or sleep issues in cancer patients. It involves virtual group classes that use mind-body practices such as mental focus exercises, controlled breathing, and body movements.

How Is the Trial Designed?

Group I: IM@Home Experimental Treatment 1 Intervention

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer

Group II: Enhanced usual care Experimental Treatment 1 Intervention

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer

Enhanced usual care is already approved in United States for the following indications:

Approved in United States as Podimetrics SmartMat for:

• Prevention of diabetic foot ulcers

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

An integrative medicine curriculum was successfully implemented for 48 preventive medicine residents over three years, focusing on community needs and collaborative projects to enhance patient-centered care.

Residents and their mentors found the curriculum valuable, as it improved their confidence and skills in interprofessional collaboration, health promotion, and population-based prevention, despite facing implementation challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Integrative Medicine to Residents: A Focus on Populations Rather Than Individual Patients. Chaudry, SS., McGuire, MJ., Lam, C., et al.[2015]

Integrative medicine (IM) is increasingly important for cancer patients, as it combines various approaches like psycho-oncology, acupuncture, and physical exercises to help manage the side effects of toxic therapies and improve overall well-being.

IM aims to bridge the gap between unproven alternative methods and conventional medicine, addressing not only the physical but also the emotional and spiritual needs of cancer survivors, who often seek more comprehensive care beyond standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The bridge between patient and doctor: the shift from CAM to integrative medicine. Diehl, V.[2018]

A home ambulatory infusion program for cancer patients receiving chemotherapy is cost-effective and allows for safe medication administration.

This program enhances patient control, autonomy, and overall quality of life for both patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Families' responses to chemotherapy by an ambulatory infusion pump. Butler, MC.[2007]

A novel telemonitoring platform for cancer patients receiving chemotherapy at home was found to be feasible and satisfactory, with 95% of patient-days having at least one data point recorded, indicating high compliance.

The combination of monitoring body weight, circadian activity, and patient-reported symptoms effectively predicted emergency hospitalizations with 94% accuracy, highlighting its potential to enhance safety in home-based chemotherapy administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Relevance of the First Domomedicine Platform Securing Multidrug Chronotherapy Delivery in Metastatic Cancer Patients at Home: The inCASA European Project. Innominato, PF., Komarzynski, S., Mohammad-Djafari, A., et al.[2018]

A pilot study involving 43 women with ovarian cancer tested the feasibility of combined modality integrative medicine (CM-IM) alongside chemotherapy, but found no significant improvements in quality of life or chemotherapy-related toxicity compared to standard treatment.

While there were no statistical differences in overall immunologic profiles, women receiving CM-IM showed higher levels of certain immune cells (CD4, CD8, and NK cells), suggesting potential benefits that require further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized trial of integrative medicine for women with ovarian cancer. Judson, PL., Dickson, EL., Argenta, PA., et al.[2021]

A needs assessment survey involving 222 respondents from eight family medicine programs indicated a strong preference (67%) for integrating integrative medicine (IM) throughout the entire residency curriculum, highlighting its perceived importance in family medicine training.

The top content areas identified for enhancement included nutrition, supplements, chronic illness, and behavioral health, with 84% of respondents viewing IM as essential for effective patient care and family medicine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative medicine in residency: assessing curricular needs in eight programs. Benn, R., Maizes, V., Guerrera, M., et al.[2022]

Mobile health monitoring allows patients with long-term conditions, like type 2 diabetes and cancer, to actively manage their medication dosages, leading to better patient care.

Studies showed that patients could effectively self-titrate their oral glucose-lowering medications and insulin, as well as adjust chemotherapy doses, with high compliance and safety through regular monitoring of their health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health for drug dose optimisation. Larsen, ME., Farmer, A., Weaver, A., et al.[2020]

In a case series of 40 patients with advanced ovarian cancer, 75% achieved remission after at least 2 months of integrative medicine (IM) treatment, suggesting that combining complementary and alternative medicine (CAM) with conventional therapies may enhance treatment outcomes.

The overall 5-year survival rate for patients was 53.1%, with those receiving only CAM showing a higher survival rate of 75%, indicating that CAM could be a beneficial addition to standard treatment protocols for ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of patients with advanced and recurrent ovarian cancer treated using integrative medicine in Malaysia: A case series. Linus-Lojikip, S., Subramaniam, V., Lim, WY., et al.[2020]

A study involving 399 patients treated by 25 homeopathic doctors demonstrated that practice-based registration is feasible for tracking patient outcomes and identifying effective homeopathic treatments.

About 22 to 26% of patients reported major improvements in their main complaints after treatment, and a strong correlation was found between patient-reported outcomes and doctors' assessments of treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Registration in Complementary/Homeopathic Medical Practice with Identification of 'Best Homeopathic Cases': A Pilot Study. Klein-Laansma, CT., Rutten, ALB., Fruijtier, PC., et al.[2019]

The Integrative Medicine in Residency (IMR) program, which included 200 hours of online and onsite training, was successfully implemented in 8 family medicine residency programs, showing high completion rates of 98.7% in the first year and 84.2% in the second year among 61 residents.

Residents demonstrated significant improvements in medical knowledge related to integrative medicine, indicating that the curriculum is effective and well-received, making it a promising model for broader adoption in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative medicine in residency education: developing competency through online curriculum training. Lebensohn, P., Kligler, B., Dodds, S., et al.[2022]

The 200-hour online integrative medicine curriculum was successfully completed by 76.9% of residents across eight family medicine programs, leading to significantly higher medical knowledge scores compared to a control group, with IMR residents scoring an average of 79.2% correct versus 53.2% for controls.

Participants rated the curriculum highly, with over 75% expressing satisfaction and a strong intention to use integrative medicine approaches after residency, indicating the program's effectiveness and potential for broader implementation in family medicine training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Medicine in Residency: Feasibility and Effectiveness of an Online Program. Lebensohn, P., Kligler, B., Brooks, AJ., et al.[2022]

The Medical Care Continuity (MCC) system, which includes video consultations and monitoring, was well-received by cancer outpatients, with 98% of participants reporting positive opinions about its usefulness.

The system effectively reduced unnecessary hospital admissions by approximately 2.2 per month, demonstrating its potential to enhance patient management and provide continuous medical support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Medical Care Continuity (MCC) project. A pilot study of video-assisted home care within the eTEN European Community program. The Italian experience. Formica, V., Fossile, E., Pellegrino, R., et al.[2021]

Chronotherapeutics, which align cancer treatments with circadian rhythms, can significantly enhance treatment tolerability and efficacy, but their success is influenced by physiological factors and gender.

Monitoring skin temperature at multiple locations is crucial for accurately determining circadian phases, as variations in temperature can indicate disruptions in circadian rhythms, highlighting the need for personalized treatment schedules in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin surface temperature rhythms as potential circadian biomarkers for personalized chronotherapeutics in cancer patients. Scully, CG., Karaboué, A., Liu, WM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05053230

A Study Evaluating the Integrative Medicine at Home (IM ... The overarching long-term goal of the Integrative Medicine for Patient-reported Outcomes Values and Experience (IMPROVE) research program is to evaluate ...

2. asco.org asco.org/abstracts-presentations/ABSTRACT428478

Effect of virtual mind-body fitness program on reduction in ... This study aimed to evaluate the effectiveness of Integrative Medicine at Home ... head/neck, and 10 (5.0%) melanoma cancer. 99 patients were randomized to ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2021-10802

Integrative Medicine for the Improvement of Patient ... This clinical trial assesses how integrative medicine at home (IM@Home) improves patient perceived values, outcomes, and experiences as they undergo cancer ...

4. nature.com nature.com/articles/s41746-024-01387-z

Randomized clinical trial of a digital integrative medicine ... We conducted a randomized controlled trial to assess the impact of a 12 week digital integrative medicine program, Integrative Medicine at Home (IM@Home), ...

5. healio.com healio.com/news/hematology-oncology/20231030/virtual-mindbody-program-cuts-need-for-emergency-care-among-patients-with-cancer

Virtual mind-body program cuts need for emergency care ... Patients assigned a virtual mind-body program experienced a lower likelihood for hospitalizations and fewer days in the hospital.

6. ascopubs.org ascopubs.org/doi/10.1200/OP.2023.19.11_suppl.473

Effect of virtual mind-body fitness program on reduction in ... This study aimed to evaluate the effectiveness of Integrative Medicine at Home (IM@Home), a virtual mind-body fitness program, on unplanned hospitalizations ...

7. withpower.com withpower.com/trial/phase-neoplasms-8-2021-07001

Integrative Medicine at Home (IM@Home) for Cancer Trial Overview The study is testing the IM@Home program to see if it can ease symptoms like tiredness, pain, or sleep issues in cancer patients. It involves ...