CancerNCT04337203

Shared Healthcare Actions and Reflections Electronic Systems in Survivorship

A study testing SHARE-S Implementation Program in people with Cancer and Survivorship, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Cancer, Survivorship, Hematopoietic and Lymphoid Cell Neoplasm
What is being tested?: SHARE-S Implementation Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 8 Sep 2020to 31 May 2022
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Declined participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Cancer, Survivorship, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Being tested: SHARE-S Implementation Program
Medical subject headings: Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHARE-S Implementation ProgramBehavioural
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).

Study groups in NCT04337203
Study group	Role	What they receive
SHARE-S	Experimental	Three components consisting of electronic referral, health coaching and tailored text/email messages for patients that have been referred to the cancer survivorship clinic. Receives: Behavioral: SHARE-S Implementation Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year, 8 months

Secondary outcomes (25)

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days after the final intervention session.
Retention Rates
Retention is defined as participants that complete the follow up assessment.
Measured: 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.
Measured: 1 year, 8 months
Participant Adherence to Coaching Sessions
Defined as adherence to completing coaching sessions during the intervention.
Measured: 1 year, 8 months
Length of Coaching Sessions
Defined as how long each completed coaching sessions lasted during the intervention.
Measured: 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.
Measured: 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.
Measured: 1 year, 8 months
Frequency of Adverse Events
Adverse events related to the intervention will be assessed in adverse event log.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and up to 30 days after the final intervention session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202031 May 2022

First posted7 Apr 2020
Study start8 Sep 2020
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04337203
Sponsor's protocol ID: IRB00064683
Other IDs: WFBCCC 99420, 1P50CA244693-01
Status last verified: Jun 2023
First submitted: 1 Apr 2020
Last updated: 28 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Price SN, Houston TK, Sadasivam RS, Wentworth S, Chandler A, Strahley A, Kittel C, Balakrishnan K, Weaver KE, Dellinger R, Puccinelli-Ortega N, Kong J, Cutrona SL, Foley KL, Sohl SJ. A qualitative study of stakeholders' experiences with and acceptability of a technology-supported health coaching intervention (SHARE-S) delivered in coordination with cancer survivorship care. Cancer Med. 2024 Jul;13(13):e7441. doi: 10.1002/cam4.7441.
PubMed 38956976