The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.
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
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
40
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).
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
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.
Time frame: 1 year, 8 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year, 8 months
Feasibility of Intervention Measure
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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.
Time frame: Up to 30 days after the final intervention session.
Retention Rates
Retention is defined as participants that complete the follow up assessment.
Time frame: 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.
Time frame: 1 year, 8 months
Participant Adherence to Coaching Sessions
Defined as adherence to completing coaching sessions during the intervention.
Time frame: 1 year, 8 months
Length of Coaching Sessions
Defined as how long each completed coaching sessions lasted during the intervention.
Time frame: 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.
Time frame: 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.
Time frame: 1 year, 8 months
Frequency of Adverse Events
Adverse events related to the intervention will be assessed in adverse event log.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and up to 30 days after the final intervention session.