Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

Wake Forest University (WFU)

Status: Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Survivorship; Cancer; Malignant Solid Neoplasm

Treatments: Behavioral: SHARE-S Implementation Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04337203

WFBCCC 99420 (Other Identifier)

IRB00064683

1P50CA244693-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

SHARE-S

Experimental group

Description:

Three components consisting of electronic referral, health coaching and tailored text/email messages for patients that have been referred to the cancer survivorship clinic.

Treatment:

Behavioral: SHARE-S Implementation Program