Dysautonomia International

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

Purpose

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.

Conditions

Head and Neck Cancer
Head and Neck Tumor
Thoracic Tumor
Thoracic Cancer
Gynecologic Cancer
Gynecologic Tumor
Melanoma
Ovarian Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy 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 Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental IM@Home	Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer	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. 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.
Other Enhanced usual care	Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer	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.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920