NCT04337203

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 28, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

April 1, 2020

Results QC Date

February 10, 2023

Last Update Submit

June 5, 2023

Conditions

CancerSurvivorshipHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (25)

  • Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]

    1 year, 8 months

  • Acceptability of Intervention Measure

    Up to 30 days after the final intervention session.

  • Appropriateness of Intervention Measure

    Up to 30 days after the final intervention session.

  • Number of Participants Enrolled Per Month

    1 year, 8 months

  • Feasibility of Intervention Measure

    Up to 30 days after the final intervention session.

  • +20 more secondary outcomes

Study Arms (1)

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.

Behavioral: SHARE-S Implementation Program

Interventions

SHARE-S Implementation ProgramBEHAVIORAL

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).

SHARE-S

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Declined participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

NeoplasmsHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Carol Kittel
Organization
Wake Forest Baptist Comprehensive Cancer Center
c.kittel@wakehealth.edu
336-399-3832

Study Officials

  • Stephanie Sohl, Ph.D

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 7, 2020

Study Start

September 8, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 28, 2023

Results First Posted

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)