A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥ 18 years or older.
  • - Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer.
  • - Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion or primary cytoreductive surgery.
  • - Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) (Patients in the ovarian basket will not be required to meet fatigue criteria in order to be enrolled.
Patients in the ovarian basket will be eligible for enrollment prior to commencement of chemotherapy)
  • - Karnofsky score 60 or greater.
  • - Life expectancy greater than six months.
  • - English speaking.

Exclusion Criteria:

  • - Cognitive impairment that would preclude response to study assessments or require the use of Legally Authorized Representatives.
  • - Unwilling to accept random assignment.
  • - Concurrently enroll onto ongoing competing trials of integrative medicine interventions with symptom/toxicity as primary outcome.
Note, however, patient will be allowed to enroll on other therapeutic protocols

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05053230
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jun Mao, MD, MSCE
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer, Gynecologic Cancer, Gynecologic Tumor, Melanoma, Ovarian Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: IM@Home

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

Placebo Comparator: Enhanced usual care

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

Interventions

Behavioral: - IM@Home

Participants in the IM@Home group will receive a 12-week virtual, synchronous, mind-body and fitness program. The Classes will be conducted via Zoom video conferencing platform. Patients will choose from a variety of weekly classes, occurring one to four times per week. An Integrative Medicine Service (IMS) clinical therapist (e.g., licensed dance therapist, certified yoga instructor, nurse specialist/physical trainer) with specific expertise in the oncology setting will lead each session. Activities range from more movement-based (fitness, yoga, dance therapy, or tai chi) to meditative-based classes (meditation, guided meditation, or music therapy). All clinicians will provide an overview of the session, 25 to 40 minutes of content, and five minutes for feedback and discussion. Each class lasts 30 to 45 minutes with optional audio or video participant participation and group chat.

Behavioral: - Enhanced usual care

Patients in the enhanced usual care will receive usual care. In addition, once enrolling into the trial, they will be given a handout to encourage them to visit the MSK's multimedia page on the Integrative Medicine website to access pre-recorded, on-demand meditation audio or video recordings for meditation, guided imagery, and relaxation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Uniondale, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

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