Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337203
• Other study ID #: IRB00064683
• Secondary ID: WFBCCC 994201P50
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Survivorship

Intervention

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).

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Retention Rates	Retention is defined as participants that complete the follow up assessment.	Up to 30 days after the final intervention session.
Secondary	Number of Participants Adhering to Text Responses	Defined as participants that adhere to responding to text messages received during intervention.	1 year, 8 months
Secondary	Participant Adherence to Coaching Sessions	Defined as adherence to completing coaching sessions during the intervention.	1 year, 8 months
Secondary	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.
Secondary	Number of Coaching Sessions Completed	Defined as an observational checklist completed for a subset of coaching sessions.	1 year, 8 months
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Engagement With the Survivorship Care Plan	Self-reported use of the care plan since enrolled on the study.	1 year, 8 months
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.