Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 480
- Locations
- 7
- Primary Endpoint
- Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief 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.
Investigators
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)
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
Outcomes
Primary Outcomes
Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
Time Frame: 12 weeks
Primary outcome will be measured by the average fatigue severity measured by the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument designed to assess one construct of fatigue severity in cancer and non-cancer populations. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes."59 A composite fatigue severity score can be found by averaging the 9 item scores.
Secondary Outcomes
- Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- Satisfaction of intervention(12 weeks)
- Number of Treatment Disruptions(12 weeks)
- Symptom intensity as measured by Edmonton Symptom Assessment Scale (ESAS)(12 weeks)
- Pain as measured by Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health(12 weeks)
- Participants treatment outcome expectancy as measured by Mao Expectancy of Treatment Effects (METE)(12 weeks)
- Recommendation of Intervention to Others(12 weeks)
- Insomnia severity as measured by Insomnia Severity Index (ISI)(12 weeks)
- Number of Unplanned medical visits(12 weeks)
- Participant Attendance to IM@Home Sessions(12 weeks)