Evaluating a home-based integrative medicine program for cancer patients
Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
This study is testing a home-based program that combines mind-body techniques to see if it can help cancer patients feel better during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05053230 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of the Integrative Medicine at Home (IM@HOME) program for patients undergoing systemic cancer treatments such as chemotherapy and radiotherapy. It focuses on integrating virtual mind-body programming to enhance patient-reported outcomes and experiences during treatment. Participants will receive either the IM@HOME intervention or enhanced usual care, with the goal of improving their perceived values and overall well-being. The study targets individuals with various types of cancer, including head and neck, thoracic, and gynecological cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific cancer diagnoses who are actively receiving systemic treatment or have recently completed treatment.
Not a fit: Patients with cognitive impairments that hinder their ability to respond to assessments or those unwilling to accept random assignment may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and treatment experiences for cancer patients.
How similar studies have performed: Other studies have shown promising results with integrative medicine approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Karolina Bryl, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Karolina Bryl, PhD
- Email: brylk@mskcc.org
- Phone: 646-608-8573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.