Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

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

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

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Cancer; Survivorship
• Intervention / Treatment: Behavioral: SHARE-S Implementation Program

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Enrolled Out of Those Electronically Referred	Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.	1 year, 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]	Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S	1 year, 8 months
Acceptability of Intervention Measure	This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability.	Up to 30 days after the final intervention session.
Appropriateness of Intervention Measure	This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness.	Up to 30 days after the final intervention session.
Number of Participants Enrolled Per Month	This will be defined as the average number of participants that enroll per month that the study is open to enrollment.	1 year, 8 months
Feasibility of Intervention Measure	This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility.	Up to 30 days after the final intervention session.
Retention Rates	Retention is defined as participants that complete the follow up assessment.	Up to 30 days after the final intervention session.
Number of Participants Adhering to Text Responses	Defined as participants that adhere to responding to text messages received during intervention.	1 year, 8 months
Participant Adherence to Coaching Sessions	Defined as adherence to completing coaching sessions during the intervention.	1 year, 8 months
Length of Coaching Sessions	Defined as how long each completed coaching sessions lasted during the intervention.	Up to 30 days after the final intervention session.
Number of Coaching Sessions Completed	Defined as an observational checklist completed for a subset of coaching sessions.	1 year, 8 months
Total Number of Patients Enrolled	Number of patients enrolled will be defined as overall participants for the entirety of the study.	1 year, 8 months
Frequency of Adverse Events	Adverse events related to the intervention will be assessed in adverse event log.	Up to 30 days after the final intervention session.
HEAL Patient-Provider Connection	Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.	Up to 30 days after the final intervention session.
Patient-Reported Health Outcomes PROMIS Profile 29	Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct.	At baseline and up to 30 days after the final intervention session.
36-Item Short Form Survey (SF-36)	Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health.	At baseline and up to 30 days after the final intervention session.
Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire	Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings.	At baseline and up to 30 days after the final intervention session.
Index of Autonomous Functioning - Self Congruence Subscale Only	The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning.	At baseline and up to 30 days after the final intervention session.
Self-Efficacy to Manage Chronic Disease Questionnaire	A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy.	At baseline and up to 30 days after the final intervention session.
Engagement With the Survivorship Care Plan	Self-reported use of the care plan since enrolled on the study.	1 year, 8 months
Satisfaction of Care	Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.	Up to 30 days after the final intervention session.
Health Behaviors Questionnaire - Tobacco Use	Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users.	At baseline and up to 30 days after the final intervention session.
Health Behaviors Questionnaire - Alcohol Use Disorder	Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous.	At baseline and up to 30 days after the final intervention session.
Health Behaviors Questionnaire - Physical Activity	Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with <90 minutes considered insufficient.	At baseline and up to 30 days after the final intervention session.
Health Behaviors Questionnaire - Fruit and Vegetable Intake	Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient.	At baseline and up to 30 days after the final intervention session.
Health Behaviors Questionnaire - Mindfulness Practice	Participants will be asked individual questions how many days/week they practice mindfulness.	At baseline and up to 30 days after the final intervention session.

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephanie Sohl, Ph.D, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB00064683; WFBCCC 99420 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center); 1P50CA244693-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No