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Recruiting
NCT05053230
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
Conditions: Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer, Gynecologic Cancer, Gynecologic Tumor, Melanoma, Ovarian Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 324
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
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.
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
Source: ClinicalTrials.gov (NCT05053230). StuddyBuddy aggregates publicly available trial information.