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.
Age ≥ 18 years or older
Karnofsky score 60 or greater
Life expectancy greater than six months
English speaking
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
Parallel
IM@Home
BehavioralParticipants 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.
Enhanced usual care
BehavioralPatients 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.
Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
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.
Symptom intensity as measured by Edmonton Symptom Assessment Scale (ESAS)
The ESAS is a brief self-report tool of symptom intensity, initially developed for patients with advanced cancer.61 It includes nine common symptoms of advanced cancer (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath), with the option of adding a tenth patient-specific symptom. It is designed to capture multidimensional symptom profiles over time by obtaining repeated quantitative measurements of symptom intensity with minimal patient burden. The original ESAS used visual analogue scales (VAS) to rate symptom intensity. A subsequent revised version replaced the VAS with 11-point numerical rating scales.
Insomnia severity as measured by Insomnia Severity Index (ISI)
The ISI has 7 items rated on a 5-point Likert response scale (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores representing more severe insomnia symptoms. The usual recall period is the "last month." The ISI authors suggest the following guidelines for interpreting the ISI total score: \< 8, no clinically significant insomnia; 8-14, subthreshold insomnia; 15-21, clinical insomnia (moderate severity); \> 21, clinical insomnia (severe). The ISI has demonstrated internal consistency, reliability, construct validity, specificity and sensitivity in a representative sample of 1670 cancer patients. The ISI has established minimally important change values to ensure that the change is not only statistically, but also clinically, meaningful to patients. A reduction of eight points has been deemed to be clinically significant improvement.
Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item scale with 7 items measuring depression and 7 items measuring anxiety. Each item is answered by the patient on a four-point (0-3) response category, so possible scores range from 0-21 for anxiety and depression, with higher scores indicating higher symptomatology. Established cutoffs are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety. Factor analysis showed two distinct but correlated factors of anxiety and depression. The scale scores have been shown to be both reliable and valid.
Pain as measured by Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health
Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health is a brief instrument composed of 10 items that demonstrates adequate reliability and validity as a measure of health-related QOL in general and clinical populations. Patients are asked to respond to questions 1-8 and 10 on a scale of 1-5. Question 9 is on a 0-10 scale (average pain rating). The measure yields two scores, Physical Health and Mental Health, that will be used as secondary outcomes to evaluate the effect of our interventions on QOL. These scores will be calculated using item-level calibrations based on item response theory (IRT) scaling and then transformed to T-Scores, which are standardized such that 50 represents the mean for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better Physical and Mental Health.
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