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

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.

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.

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.

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.

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.

Mao Expectancy of Treatment Effects (METE): is a four-item instrument originally developed as the Acupuncture Expectancy Scale (AES) by Mao (PI) et al. Outcome expectancy has long been considered an important predictor of treatment outcomes and has gained increasing recognition in clinical trials. It has demonstrated reliability (Cronbach's α of 0.82) and validity and is positively correlated with patient self-reported efficacy and satisfaction. The score ranges from 4 to 20, with higher scores indicating greater expectancy. We will use this measure to explore whether expectancy predicts treatment outcomes and may impact the observed differences between groups.

Satisfaction will be measured through a five-point Likert scale assessing overall approval and recommendations for improvement. Trevino et al. (2020) demonstrated high engagement and satisfaction with IMS remotely delivered mind-body services, including fitness, meditation, yoga.77 Furthermore, qualitative interviews will be conducted using thematic content analysis to determine program satisfaction and triangulate quantitative data.

Willingness to recommend the intervention will be measured by a one-item assessment. Participants will be asked their willingness to recommend the intervention to a friend, family member, or fellow cancer patient/survivor.

Record on treatment disruption will be extracted from MSK EMR via DataLine. This includes records on dose reduction, dose delay, and treatment discontinuation. Participants will also self-report and comment on treatment disruption in log. Dose reduction is defined as any dosage decrease or adjustment relative to dosage at the start of intended systemic regimen. Dose delay is defined as any delay or temporary stoppage in administration of systemic regimen relative to the intended schedule. Treatment discontinuation is defined as permanent discontinuation of the intended systemic regimen that does not include treatment completion during intervention. The treatment variables will be abstracted by the clinical research coordinators and adjudicated with guidance from the collaborating medical oncologists in the specific services.

Record on unplanned medical visits to the urgent care, emergency room, and hospitalization will be patient-reported and extracted from MSK EMR via DataLine. For each unplanned medical visit, CPT code, ICD-10 code, chief complaints, and the length of stay will be collected. Unplanned medical visit data will also be tracked at partner hospitals in collaboration with ambulatory care. Participants will also self-report and comment on unplanned medical visits in log.

Participants will self-report attendance in a weekly log of the number and type of classes attended. Once randomized, participants will be instructed to record their attendance in the mind-body classes throughout the week. A log will be sent out through the MSK Engage, where participants can fill out their attendance at the end of each week.