A randomized prospective trial of an ostomy telehealth intervention for cancer survivors

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BACKGROUND: Cancer survivors with ostomies face complex challenges. This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC). METHODS: Three academic centers randomized participants. OSMT group sessions were led by ostomy nurses and peer ostomates (three for ostomates-only, one for support persons, and one review session for both). Surveys at baseline, OSMT completion, and 6 months were primary outcome patient activation (PAM), self-efficacy (SE), City of Hope quality of life-Ostomy (COH-O), and Hospital Anxiety and Depression Scale (HADS). Surveys were scored per guidelines for those completing at least two surveys. Linear mixed effects models were used to select potential covariates for the final model and to test the impact of OSMT within each timeframe. RESULTS: A total of 90 OSMT and 101 UC fulfilled analysis criteria. Arms were well-matched but types of tumors were unevenly distributed (p = .023). The OSMT arm had a nonsignificant improvement in PAM (confidence interval [CI], -3.65 to 5.3]; 4.0 vs. 2.9) at 6 months. There were no significant differences in other surveys. There was a significant OSMT benefit for urinary tumors (four SE domains). Higher OSMT session attendance was associated with post-session improvements in five SE domains (p < .05), two COH-O domains (p < .05), and HADS anxiety (p = .01). At 6 months, there remained improvements in one SE domain (p < .05), one COH-O domain (p < .05), and HADS anxiety (p < .01). CONCLUSIONS: No clear benefit was seen for the OSMT intervention, although there may be an advantage based on type of tumor. Benefit with greater session attendance was also encouraging. PLAIN LANGUAGE SUMMARY: Cancer patients with ostomies have many challenges. We tested a telehealth curriculum compared to usual care. There are indications of benefit for the program for those that attend more sessions and those with urostomies.

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