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

Study Overview
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Brief Summary
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The purpose of this study is to find out whether the Integrative Medicine at Home (IM@Home) program can help reduce patients' symptoms (such as tiredness, pain, or insomnia) and improve their satisfaction with treatment for their disease. The IM@Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice. Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind.

Official Title
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Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)

Conditions
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Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer, Gynecologic Cancer, Gynecologic Tumor, Melanoma

Intervention / Treatment
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* Behavioral: IM@Home
* Behavioral: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years or older Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IM@Home<br>Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer | Behavioral: IM@Home<br>* Participants will be enrolled into either IM@Home or enhanced usual care for the study duration of 12 weeks. IM@Home is an online mind-body program consisted of a series of virtual, synchronous classes that offer a variety of rigorously tested mind-body therapies led by an Integrative Medicine Service (IMS) clinical therapist. The virtual mind-body group therapy sessions will be conducted using Zoom video conferencing platform.<br>|
| Placebo Comparator: Enhanced usual care<br>Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer | Behavioral: Enhanced usual care<br>* 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 videos/audios<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Fatigue Severity from the Brief Fatigue Inventory (BFI) | Primary outcome will be measured by the average fatigue severity measured by the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument designed to assess one construct of fatigue severity in cancer and non-cancer populations. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes.59 A composite fatigue severity score can be found by averaging the 9 item scores. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer, head and neck tumor, thoracic tumors, gynecological tumors, melanoma, 21-369, Memorial Sloan Kettering Cancer Center