NCT04765072

Brief Summary

Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable cancer

Timeline
33mo left

Started Feb 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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

Study Progress66%
Feb 2021Feb 2029

First Submitted

Initial submission to the registry

February 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

6.9 years

First QC Date

February 12, 2021

Last Update Submit

November 12, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)

    Approximately 12 months

  • Measure effectiveness of Telehealth on survivorship care

    Approximately 12 months

  • Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings

    Approximately 1 year

  • Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings

    Approximately 1 year

Study Arms (1)

Survivorship care

EXPERIMENTAL

Participants in rural areas will receive a telehealth (providing health-related services through electronic communication technologies) survivorship care plan in combination with assistance from a patient navigator.

Behavioral: Survivorship Patient Navigation InterventionBehavioral: Telehealth Survivorship Visit Intervention

Interventions

Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources

Survivorship care

Individualized survivorship care plan

Survivorship care

Eligibility Criteria

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

You may qualify if:

  • Cancer patient at least 18 years of age at time of cancer therapy
  • English-speaking with the ability to provide informed consent
  • Received treatment for Stage 0 - III cancer with curative intent
  • Completed cancer therapy within the previous 12 months (i.e., 12 months prior to consenting) and in complete remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baptist Cancer Center- Golden Triangle Columbus

Columbus, Mississippi, 39705, United States

Location

Baptist Cancer Center - North Mississippi

Oxford, Mississippi, 38655, United States

Location

Baptist Cancer Center- Bartlett

Bartlett, Tennessee, 38133, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Debra Friedman, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 21, 2021

Study Start

February 26, 2021

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations