The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer.

Background The NIH consensus statement on cancer-related symptoms concluded the most common and debilitating were depression, pain and fatigue (American Cancer Society, 2019; Qaseem et al., 2008; Meijer et al., 2013; Meijer, 2011 [1-6]). Although the comorbidity of these symptoms is well known and may have similar underlying biological mechanisms; yet no intervention has been developed to reduce these symptoms concurrently. The novel web-based stepped collaborative care intervention delivered by telemedicine is the first to be tested in people diagnosed with cancer. Methods We plan to test a web-based stepped collaborative care intervention with 450 cancer patients and 200 caregivers in the context of a randomized controlled trial. The primary outcomes include the assessment of patient-reported depression, pain, fatigue and quality of life. Secondary outcome include patient serum levels of pro-inflammatory cytokines and disease progression. We also will assess informal caregiver stress, depression, and metabolic syndrome to determine if improvements in patients' symptoms also result in improvement in caregiver outcomes. Results The trial is ongoing and a total of 370 patient have been randomized. Preliminary analyses of the screening tools used for study entry suggest that Center for Epidemiological Studies-Depression (CESD) scale has good sensitivity and specificity (0.77 and 0.85) whereas the scale used to assess pain (0.47 and 0.91) and fatigue (0.11 and 0.91) had poor sensitivity but excellent specificity. Using the AUROC, the best cut point for the CES-D was 15.5, for pain was 4.5; and for fatigue was 2.5. Outcomes not originally proposed included health care utilization and healthcare charges. For the first 100 patients who have been followed a year post-treatment, and who were less than 75 years and randomized to the web-based stepped collaborative care intervention, had lower rates of complications after surgery [χ2 = 5.45, p = 0.02]. For patients who survived 6 months or less and were randomized to the web-based stepped collaborative care intervention, had lower rates of 90-day readmissions when compared to patients randomized to the screening and referral arm [χ2 = 4.0, p = 0.046]. Patients randomized to the collaborative care intervention arm had lower mean overall health care charges of $19,546 per patient per year when compared to the screening and referral arm. In a separate analyses focused on the caregivers, we found that after adjusting for age, gender, and race; low levels of caregiver quality of life (HR = 1.067, 95% CI = 1.019-1.117, p = 0.006), high levels of hostility (HR = 1.142, 95% CI = 1.030-1.267, p = 0.012), and alcohol use (HR = 4.193, 95% CI = 1.174-14.978, p = 0.027) were significant predictors of metabolic syndrome. Discussion This novel web-based stepped stepped collaborative care intervention, delivered via telemedicine, is expected to provide a new strategy to improve the quality of life in those diagnosed with cancer and their caregivers. Trial registration ClinicalTrials.gov NCT02939755.