Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
Study Details
Study Description
Brief Summary
The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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To assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity).
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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.
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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).
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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.
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To qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded.
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To examine how study results vary by cancer type.
Study Design
Arms and Interventions
| 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).
|
Outcome Measures
Primary Outcome Measures
- Proportion of Patients Enrolled - Those Electronically Referred [Up to 16 months]
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 be referred to SHARE-S
Secondary Outcome Measures
- Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review] [Up to 16 months]
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
- Acceptability of Intervention Measure [Up to 2 years]
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types.
- Appropriateness of Intervention Measure [Up to 2 years]
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types.
- Number of Participants Enrolled Per Month [Up to 16 months]
This will be defined as the average number of participants that enroll per month that the study is open to enrollment.
- Feasibility of Intervention Measure [Up to 2 years]
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types.
- Retention Rates [Up to 2 years]
Retention is defined as participants that complete the follow up assessment.
- Number of Participant Adhering to Text Responses [Up to 2 years]
Defined as patient that adhere to responding to text messages received during intervention.
- Participant Adherence to Coaching Sessions [Up to 2 years]
Defined as adherence to completing coaching sessions during the intervention.
- Length of Coaching Sessions [Up to 2 years]
Defined as how long each completed coaching sessions lasted during the intervention.
- Number of Coaching Sessions Completed [Up to 2 years]
Defined as an observational checklist completed for a subset of coaching sessions.
- Total Number of Patients Enrolled [Up to 2 years]
Number of patients enrolled will be defined as overall participants for the entirety of the study.
- Frequency of Adverse Events [Up to 30 days after final intervention.]
Adverse events related to the intervention will be assessed in adverse event log.
- HEAL Patient-Provider Connection [Up to 30 days after final study intervention]
Patient reported measure of patient-centered communication/relatedness completed only at follow-up.
- Patient-Reported Health Outcomes PROMIS Profile 29 [At baseline and 30 days after the final study intervention]
Questionnaire to assess the social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Score scale ranges (1-5) and some areas are reverse scored.
- 36-Item Short Form Survey (SF-36) [At baseline and 30 days after the final study intervention]
Participants will only answer the single item question that provides an indication of perceived change in health. Score range is 1 - excellent, 2 - very good, 3 - good, 4 - fair and 5 - poor.
- Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire [At baseline and 30 days after the final study intervention]
Investigators will only assess the quality of life of adult cancer survivors measuring 5 domains of cancer survivorship that are cancer-specific (financial problems, family distress, recurrence distress, appearance concerns, benefits from cancer). Score scale - 1 = never 2 = seldom 3 = sometimes 4 = about as often as not 5 = frequently 6 = very often 7 = always.
- Health Behaviors Questionnaire [At baseline and 30 days after the final study intervention]
Participants will be asked individual questions about their health behaviors (i.e., tobacco use, alcohol use, physical activity and nutrition
- Index of Autonomous Functioning [At baseline and 30 days after the final study intervention]
The Index of Autonomous Functioning provides a brief and reliable measure of trait autonomy based on three theoretically derived subscales assessing authorship/self-congruence, interest-taking, and low susceptibility to control. 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." Higher score indicate a higher level of functioning.
- Self-Efficacy to Manage Chronic Disease Questionnaire [At baseline and 30 days after the final study intervention]
A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Minimum score of 6, maximum score of 60.The higher the score indicates higher self-efficacy.
- Engagement with the Survivorship Care Plan [Through study completion, up to 2 years]
Self-reported use of the care plan since enrolled on the study.
- Satisfaction of Care [Through study completion, up to 2 years]
Participants will evaluate their overall satisfaction with their care after the study intervention.
- Time to Implementation of Program [Up to 16 months]
Implementation will be defined as from the opening of the study to the first patient electronically referred and time to the 10th patient electronically referred
- Method Used for Electronic Referrals [Up to 2 years]
Indication of whether referrals were through scheduling an appointment or required review of upcoming appointments. Investigators will use a combination of field notes, electronic medical record notes and direct observation to measure this milestone
- Cancer Type and Time of Diagnosis [Up to 2 years]
Abstracted from the medical charts or self-reported by participants to indicate which types of cancer and the time of diagnosis.
- Demographic Characteristics of Participants [At baseline]
Abstracted from the medical charts or self-reported by participants for descriptive purposes (age, sex, rural-urban residence, race/ethnicity, marital status, education level and health literacy).
- Qualitative Data Collection [Up to 2 years]
Qualitative assessment of barriers and facilitators guided by Consolidated Framework for Implementation Research (CFIR)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults ≥18 years of age
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Documented or planned cancer survivorship visit
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Have a texting enabled telephone
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Cognitively able to complete study procedures as judged by the study team
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephanie Sohl, Ph.D, Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00064683
- WFBCCC 99420
- 1P50CA244693-01