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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Melanoma; Gynecologic Cancer; Gynecologic Tumor; Ovarian Cancer; Thoracic Tumor; Head and Neck Cancer; Thoracic Cancer; Head and Neck Tumor

Treatments: Behavioral: IM@Home; Behavioral: Enhanced usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05053230

21-369

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

IM@Home

Experimental group

Description:

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer

Treatment:

Behavioral: IM@Home

Enhanced usual care

Other group

Description:

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer

Treatment:

Behavioral: Enhanced usual care