Dataset Information

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.

ABSTRACT:

Background

Cancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the "Patient Reported Outcomes-Informed Symptom Management System" (PRISMS) during post-ostomy creation care transition.

Methods

We conducted a 2-arm pilot randomized controlled trial among 23 patients who received surgical treatment with curative intent for bladder and colorectal cancer and their caregivers. After assessing QOL, general symptoms, and caregiver burden at baseline, participants were randomly assigned to PRISMS (n = 16 dyads) or usual care (UC) (n = 7 dyads). After a 60-day intervention period, participants completed a follow-up survey and post-exit interview. We used descriptive statistics and t-tests to analyze the data.

Results

We achieved an 86.21% recruitment rate and a 73.91% retention rate. Among the PRISMS participants who used the system and biometric devices (n = 14, 87.50%), 46.43% used the devices for ≥ 50 days during the study period. Participants reported PRISMS as useful and acceptable. Compared to their UC counterparts, PRISMS patient social well-being scores decreased over time and had an increased trend of physical and emotional well-being; PRISMS caregivers experienced a greater decrease in caregiver burden.

Conclusions

PRISMS recruitment and retention rates were comparable to existing family-based intervention studies. PRISMS is a useful and acceptable multilevel intervention with the potential to improve the health outcomes of cancer patients needing ostomy care and their caregivers during post-surgery care transition. A sufficiently powered RCT is needed to test its effects.

Trial registration

ClinicalTrial.gov ID: NCT04492007. Registration date: 30/07/2020.

SUBMITTER: Xu S

PROVIDER: S-EPMC10257159 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.

Xu Shenmeng S Tan Xianming X Ma Chunxuan C McElyea Rebecca S RS Shieh Karl K Stover Angela M AM Smith Angela A Stitzenberg Karyn K Basch Ethan E Song Lixin L

BMC cancer 20230610 1

<h4>Background</h4>Cancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the "Patient Reported Outcomes-Informed Symptom Management System" (PRISMS) during post-ostomy creation care transition.<h4>Methods</h4>We conducted a 2-arm pilot randomized controlled trial among 23 patients who rec ...[more]

PMID: 37301841

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Dataset Information

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.

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