Integrative Medicine at Home (IM@Home) for Cancer

(IMPROVE Trial)

Recruiting at 6 trial locations

Overseen By Tony Hung, 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

Trial Summary

What is the purpose of this trial?

The overarching long-term goal of the Integrative Medicine for Patient-reported Outcomes Values and Experience (IMPROVE) research program is to evaluate whether integrating a virtual mind-body programming, Integrative Medicine at Home (IM@Home), will improve patient perceived values, outcomes, and experiences as they undergo systemic cancer treatment such as chemotherapy, immunotherapy, radiotherapy, targeted agents, cytoreductive surgery.

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.

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

Integrative medicine, which combines conventional treatments with complementary therapies, has been shown to help cancer patients better tolerate toxic therapies and improve their quality of life. A study on women with ovarian cancer found that integrative medicine could positively affect quality of life and reduce chemotherapy toxicity. ^{1 2 3 4 5}

Is the Integrative Medicine at Home (IM@Home) program safe for cancer patients?

Research on telehealth and home-based care for cancer patients, like the IM@Home program, suggests that these approaches can improve safety by allowing patients to stay at home while receiving treatment, which can enhance their well-being and reduce healthcare costs. ^{6 7 8 9 10}

How is the Integrative Medicine at Home (IM@Home) treatment for cancer unique compared to other treatments?

The IM@Home treatment is unique because it combines remote foot temperature monitoring with virtual mind-body fitness classes, focusing on enhancing usual care by addressing both physical and mental well-being. This integrative approach aims to help patients better tolerate cancer therapies and actively participate in their own health improvement, which is different from traditional treatments that may not address emotional and spiritual needs. ^{3 4 11 12 13}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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 am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Survival of patients with advanced and recurrent ovarian cancer treated using integrative medicine in Malaysia: A case series. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Electronic Registration in Complementary/Homeopathic Medical Practice with Identification of 'Best Homeopathic Cases': A Pilot Study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Integrative Medicine in Residency: Feasibility and Effectiveness of an Online Program. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized trial of integrative medicine for women with ovarian cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Mobile health for drug dose optimisation. [2020]

8. Canada 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. [2018]

9. Germany 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Skin surface temperature rhythms as potential circadian biomarkers for personalized chronotherapeutics in cancer patients. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Integrative medicine in residency education: developing competency through online curriculum training. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Integrative medicine in residency: assessing curricular needs in eight programs. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Teaching Integrative Medicine to Residents: A Focus on Populations Rather Than Individual Patients. [2015]