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
• Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian 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) (Patients in the ovarian basket will not be required to meet fatigue criteria in order to be enrolled. Patients in the ovarian basket will be eligible for enrollment prior to commencement of chemotherapy)
• Karnofsky score 60 or greater
• Life expectancy greater than six months
• English speaking

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