Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
NCT ID: NCT04337203
Last Updated: 2023-06-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2020-09-08
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway
NCT07175376
CONNECTing Head and Neck Caregivers to Supportive Care Resources
NCT03875885
SHARE (Sharing Goals and Preferences) Study
NCT03392090
Patient Navigation in Cancer Survivorship at a Safety Net Institution
NCT03271099
Expanding Rural Health Cancer Control Capacity
NCT04765072
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
• 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHARE-S
Three components consisting of electronic referral, health coaching and tailored text/email messages for patients that have been referred to the cancer survivorship clinic.
SHARE-S Implementation Program
The 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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHARE-S Implementation Program
The 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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented or planned cancer survivorship visit
* Have a texting enabled telephone
* Cognitively able to complete study procedures as judged by the study team
* Able to understand, read and write English
Children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephanie Sohl, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WFBCCC 99420
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00064683
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.