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RecruitingInterventional

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

NCT ID: NCT05053230Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2025-10-09

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.

Arms & interventions

  • BehavioralIM@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.

  • BehavioralEnhanced 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.

Outcome measures

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.

    Time frame: 12 weeks

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Karolina Bryl, PhD · Contact

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Karolina Bryl, PhD · Contact

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Karolina Bryl, PhD · Contact

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

Commack, New York, 11725

Recruiting
Karolina Bryl, PhD · Contact

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
Karolina Bryl, PhD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Karolina Bryl, PhD · Contact

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Recruiting
Karolina Bryl, PhD · Contact

References

  • 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.(PubMed)
  • 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.(PubMed)