MedPath

Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

Not Applicable
Completed
Conditions
Cancer
Survivorship
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Interventions
Behavioral: SHARE-S Implementation Program
Registration Number
NCT04337203
Lead Sponsor
Wake Forest University Health Sciences
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SHARE-SSHARE-S Implementation ProgramThree components consisting of electronic referral, health coaching and tailored text/email messages for patients that have been referred to the cancer survivorship clinic.
Primary Outcome Measures
NameTimeMethod
Number of Patients Enrolled Out of Those Electronically Referred1 year, 8 months

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.

Secondary Outcome Measures
NameTimeMethod
Participant Adherence to Coaching Sessions1 year, 8 months

Defined as adherence to completing coaching sessions during the intervention.

Number of Coaching Sessions Completed1 year, 8 months

Defined as an observational checklist completed for a subset of coaching sessions.

Frequency of Adverse EventsUp to 30 days after the final intervention session.

Adverse events related to the intervention will be assessed in adverse event log.

Acceptability of Intervention MeasureUp to 30 days after the final intervention session.

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.

Number of Participants Adhering to Text Responses1 year, 8 months

Defined as participants that adhere to responding to text messages received during intervention.

Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]1 year, 8 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

Appropriateness of Intervention MeasureUp to 30 days after the final intervention session.

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.

Feasibility of Intervention MeasureUp to 30 days after the final intervention session.

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.

Retention RatesUp to 30 days after the final intervention session.

Retention is defined as participants that complete the follow up assessment.

Length of Coaching SessionsUp to 30 days after the final intervention session.

Defined as how long each completed coaching sessions lasted during the intervention.

36-Item Short Form Survey (SF-36)At baseline and up to 30 days after the final intervention session.

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.

Index of Autonomous Functioning - Self Congruence Subscale OnlyAt baseline and up to 30 days after the final intervention session.

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.

Health Behaviors Questionnaire - Physical ActivityAt baseline and up to 30 days after the final intervention session.

Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with \<90 minutes considered insufficient.

Health Behaviors Questionnaire - Fruit and Vegetable IntakeAt baseline and up to 30 days after the final intervention session.

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.

Number of Participants Enrolled Per Month1 year, 8 months

This will be defined as the average number of participants that enroll per month that the study is open to enrollment.

Total Number of Patients Enrolled1 year, 8 months

Number of patients enrolled will be defined as overall participants for the entirety of the study.

HEAL Patient-Provider ConnectionUp to 30 days after the final intervention session.

Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.

Health Behaviors Questionnaire - Mindfulness PracticeAt baseline and up to 30 days after the final intervention session.

Participants will be asked individual questions how many days/week they practice mindfulness.

Health Behaviors Questionnaire - Tobacco UseAt baseline and up to 30 days after the final intervention session.

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.

Patient-Reported Health Outcomes PROMIS Profile 29At baseline and up to 30 days after the final intervention session.

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.

Health Behaviors Questionnaire - Alcohol Use DisorderAt baseline and up to 30 days after the final intervention session.

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.

Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) QuestionnaireAt baseline and up to 30 days after the final intervention session.

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.

Self-Efficacy to Manage Chronic Disease QuestionnaireAt baseline and up to 30 days after the final intervention session.

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.

Engagement With the Survivorship Care Plan1 year, 8 months

Self-reported use of the care plan since enrolled on the study.

Satisfaction of CareUp to 30 days after the final intervention session.

Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

🇺🇸

Winston-Salem, North Carolina, United States

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