Clinical Trials Directory

Trials / Completed

CompletedNCT04337203

Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic Systems in Survivorship

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.

Detailed description

Primary Objectives: • To evaluate how successfully SHARE-S can be implemented into clinical care as characterized by rates of enrollment. Investigators hypothesize \>30% of patients e-referred to SHARE-S will enroll. Secondary Objectives: * To assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity). * To describe service outcome variability to inform future studies. Investigators will assess service outcomes relevant to Commission on Cancer requirements by reporting annual estimates for: (1) the estimated number of patients impacted by SHARE-S; (2) the cancer sites impacted by SHARE-S; and the (3) resources/processes utilized to enhance each of the chosen services if barriers were encountered. We will also assess safety and perceived patient-centeredness of care. * To describe patient health outcome variability to inform future studies (i.e., social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain, cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for managing cancer, engagement with the survivorship care plan document, and satisfaction with care). * To evaluate the Implementation Program we will assess key milestones and processes for this pilot study of the Implementation Stage measured at the clinic level. * To qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded. * To examine how study results vary by cancer type.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSHARE-S Implementation ProgramThe program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks).

Timeline

Start date
2020-09-08
Primary completion
2022-05-31
Completion
2022-05-31
First posted
2020-04-07
Last updated
2023-06-28
Results posted
2023-06-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04337203. Inclusion in this directory is not an endorsement.