A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
IMPROVE
Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
1 other identifier
interventional
480
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Sep 2021
Longer than P75 for not_applicable head-and-neck-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 20, 2026
October 9, 2025
October 1, 2025
5 years
September 20, 2021
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
Symptom intensity as measured by Edmonton Symptom Assessment Scale (ESAS)
12 weeks
Insomnia severity as measured by Insomnia Severity Index (ISI)
12 weeks
Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS)
12 weeks
Pain as measured by Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health
12 weeks
Participants treatment outcome expectancy as measured by Mao Expectancy of Treatment Effects (METE)
12 weeks
- +5 more secondary outcomes
Study Arms (2)
IM@Home
EXPERIMENTALParticipants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer
Enhanced usual care
OTHERParticipants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years or older
- Karnofsky score 60 or greater
- Life expectancy greater than six months
- English speaking
- Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or gynecologic 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 with a diagnosis or clinical suspicion of gynecologic malignancy who have completed definitive first line treatment (maintenance hormonal or targeted therapies are allowed)
- Patients with a diagnosis of Stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or Leukemia
- Actively receiving oncological treatment, radiotherapy or active surveillance
- Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) (maintenance hormonal or targeted therapies are allowed).
- Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Publications (2)
Bryl KL, Silverwood S, Desai K, Schobert K, Li X, Chimonas S, Mao JJ, Gillespie EF. Benefits and Challenges of a Digital Exercise and Mind-Body Program During Active Cancer Treatment: Qualitative Study of Patients' Perceptions. JMIR Cancer. 2026 Jan 16;12:e80075. doi: 10.2196/80075.
PMID: 41543884DERIVEDMao JJ, Bryl K, Gillespie EF, Green A, Hung TKW, Baser R, Panageas K, Postow MA, Daly B. Randomized clinical trial of a digital integrative medicine intervention among patients undergoing active cancer treatment. NPJ Digit Med. 2025 Jan 14;8(1):29. doi: 10.1038/s41746-024-01387-z.
PMID: 39809874DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karolina Bryl, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 22, 2021
Study Start
September 20, 2021
Primary Completion (Estimated)
September 20, 2026
Study Completion (Estimated)
September 20, 2026
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.