Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

NCT ID: NCT04337203

Last Updated: 2023-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2022-05-31

Brief Summary

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

Detailed Description

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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

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Cancer Survivorship Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SHARE-S Implementation Program

Intervention Type BEHAVIORAL

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

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults ≥18 years of age
* 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

\- Declined participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Sohl, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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WFBCCC 99420

Identifier Type: OTHER

Identifier Source: secondary_id

1P50CA244693-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00064683

Identifier Type: -

Identifier Source: org_study_id

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