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Recruiting NCT05053230

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

No phase Interventional Head and Neck Cancer Head and Neck Tumor Thoracic Tumor Thoracic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IM@Home, Enhanced usual care.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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. Activ
  • 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.

Primary outcome measures

  • Average Fatigue Severity from the Brief Fatigue Inventory (BFI) [Time frame: 12 weeks]
Secondary outcome measures (10)
  • Symptom intensity as measured by Edmonton Symptom Assessment Scale (ESAS) [Time frame: 12 weeks]
  • Insomnia severity as measured by Insomnia Severity Index (ISI) [Time frame: 12 weeks]
  • Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS) [Time frame: 12 weeks]
  • Pain as measured by Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health [Time frame: 12 weeks]
  • Participants treatment outcome expectancy as measured by Mao Expectancy of Treatment Effects (METE) [Time frame: 12 weeks]
  • Satisfaction of intervention [Time frame: 12 weeks]
  • Recommendation of Intervention to Others [Time frame: 12 weeks]
  • Number of Treatment Disruptions [Time frame: 12 weeks]
  • Number of Unplanned medical visits [Time frame: 12 weeks]
  • Participant Attendance to IM@Home Sessions [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years or older
  • Karnofsky score 60 or greater
  • Life expectancy greater than six months
  • English speaking

Additional Inclusion Criteria for Head and Neck, Thoracic, Gynecologic, Melanoma and Breast Baskets

  • 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)

Additional Inclusion Criteria for First Remission Gynecologic Cancer Basket

  • Patients with a diagnosis or clinical suspicion of gynecologic malignancy who have completed definitive first line treatment (maintenance hormonal or targeted therapies are allowed)

Additional Inclusion Criteria for the Advanced Cancer Basket:

  • 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

Additional Inclusion Criteria for the Cancer Survivor Basket:

  • 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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Publications

  • 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 41543884
  • Mao 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 39809874

Identifiers

NCT: NCT05053230 · 21-369

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗