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NCT05053230 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— IMPROVE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05053230
Other study ID # 21-369
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date September 20, 2024

Study information
Verified date October 2023
Source Memorial Sloan Kettering Cancer Center
Contact Jun Mao, MD, MSCE
Phone 646-888-0863
Email maoj@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 20, 2024
Est. primary completion date September 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• IM@Home
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.
• 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 videos/audios

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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