Clinical trial NCT04337203: Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
Official title: SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic Systems in Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Survivorship
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of Patients Enrolled Out of Those Electronically Referred
timeFrame: 1 year, 8 months
Secondary outcomes:
measure: Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]
timeFrame: 1 year, 8 months
measure: Acceptability of Intervention Measure
timeFrame: Up to 30 days after the final intervention session.
measure: Appropriateness of Intervention Measure
timeFrame: Up to 30 days after the final intervention session.
measure: Number of Participants Enrolled Per Month
timeFrame: 1 year, 8 months
measure: Feasibility of Intervention Measure
timeFrame: Up to 30 days after the final intervention session.
measure: Retention Rates
timeFrame: Up to 30 days after the final intervention session.
measure: Number of Participants Adhering to Text Responses
timeFrame: 1 year, 8 months
measure: Participant Adherence to Coaching Sessions
timeFrame: 1 year, 8 months
measure: Length of Coaching Sessions
timeFrame: Up to 30 days after the final intervention session.
measure: Number of Coaching Sessions Completed
timeFrame: 1 year, 8 months
measure: Total Number of Patients Enrolled
timeFrame: 1 year, 8 months
measure: Frequency of Adverse Events
timeFrame: Up to 30 days after the final intervention session.
measure: HEAL Patient-Provider Connection
timeFrame: Up to 30 days after the final intervention session.
measure: Patient-Reported Health Outcomes PROMIS Profile 29
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: 36-Item Short Form Survey (SF-36)
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Index of Autonomous Functioning - Self Congruence Subscale Only
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Self-Efficacy to Manage Chronic Disease Questionnaire
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Engagement With the Survivorship Care Plan
timeFrame: 1 year, 8 months
measure: Satisfaction of Care
timeFrame: Up to 30 days after the final intervention session.
measure: Health Behaviors Questionnaire - Tobacco Use
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Health Behaviors Questionnaire - Alcohol Use Disorder
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Health Behaviors Questionnaire - Physical Activity
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Health Behaviors Questionnaire - Fruit and Vegetable Intake
timeFrame: At baseline and up to 30 days after the final intervention session.
measure: Health Behaviors Questionnaire - Mindfulness Practice
timeFrame: At baseline and up to 30 days after the final intervention session.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephanie Sohl, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: