Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors (SHAREDCare)

Toward an Integrated Approach to Assessing and Addressing Follow-Up Care Needs That Will Facilitate Care Transitions for Cancer Survivors: A Pilot Study

This clinical trial evaluates whether a shared response plan (SHAREDCare) improves follow-up care for lung cancer survivors. As the number of cancer survivors increases, there is a new need for high-quality chronic illness care. High-quality chronic illness care can be difficult to deliver and involves working with the patient to be certain they have what they need to be actively involved with their care to meet their needs. SHAREDCare allows the patient to work with a navigator to review identified distress and social needs. The patient and navigator discuss the needs and develop a shared response plan to address the needs in ways that consider the patient's current behaviors, beliefs, and motivation. The plan also establishes specific patient goals, anticipates barriers, and establishes how the navigator will follow-up on the needs and adjust care and assistance when needed. Using a shared response plan may improve follow-up care for lung cancer survivors.

Study Overview

• Status: Terminated
• Conditions: Stage IV Lung Cancer; Stage III Lung Cancer; Stage I Lung Cancer; Stage II Lung Cancer
• Intervention / Treatment: Behavioral: Telephone based interview; Other: Survey using a questionnaire.; Other: Electronic health record review; Other: Referral

Detailed Description

Primary Objective: Pilot and qualitatively assess the acceptability of SHAREDCare through semi- structured interviews

Secondary Objectives:

• Describe quantitative assessments of intervention acceptability, appropriateness, and feasibility.
• Describe survivor level of unmet needs13 using a validated measure to collect data before and/or after completion of the SHAREDCare intervention.
• Track clinical referrals and other actions made as a result of patient responses on the Electronic Distress Screening (EDS) and the percentage of referrals that have been "completed" (i.e. those referrals where a patient completed the relevant medical or social needs-related visit).
• Track recruitment, assessment completion, and any related adverse events.

OUTLINE:

Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.

After completion of study intervention, patients are followed up 4 weeks after initial call.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed study disease. A pathology report should be referenced/available (stages I-IV lung cancer)
• Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
• ≥ 18 years of age
• Within two years of lung cancer diagnosis
• Able to understand, read and write English

Exclusion Criteria: Does not meet the above inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SHAREDCare Supportive care arm; Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.

Behavioral: Telephone based interview; Receive SHAREDCare navigator calls; Other: Survey using a questionnaire.; Ancillary studies; Other: Electronic health record review; Ancillary studies; Other: Referral; Receive standard of care automated referrals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHAREDCare's Qualitative Acceptability	Will be assessed with semi-structured interviews. These methods will be guided by Grounded Theory, a process using inductive coding to develop theory from data (e.g., themes relating to components, timing, or delivery of the intervention).	At 4 weeks post-initial call

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHAREDCare's Quantitative Acceptability	Will be measured with the Acceptability of Intervention Measure. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and acceptability. Distributions of continuous variables (acceptability) will be examined for estimation of standard deviations (SD) that will be used to inform power analysis for future studies.	At 4 weeks post-initial call
SHAREDCare's Quantitative Appropriateness	Will be measured with the Intervention Appropriateness Measure. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and appropriateness. Distributions of continuous variables (acceptability) will be examined for estimation of SD that will be used to inform power analysis for future studies.	At 4 weeks post-initial call
SHAREDCare's Quantitative Feasibility	Will be measured with the Feasibility Intervention Measure. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and feasibility. Distributions of continuous variables (acceptability) will be examined for estimation of SD that will be used to inform power analysis for future studies	At 4 weeks post-initial call
Number of Survivors With Unmet Needs	Will be assessed before and/or after completion of the SHAREDCare intervention using a validated measure called the Survivor Unmet Needs Survey. This measure will be used to determine the prevalence and predictors of cancer survivors' unmet needs. Scores at baseline and follow-up will be summarized as median (interquartile range, range). Changes will be tested by Wilcoxon signed-rank test.	At baseline and at 4 weeks post-initial call
Number of Clinical Referrals Made	Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and referrals.	At 4 weeks post-initial call
Percentage of Referrals Completed	Will be defined as those referrals where a patient self-reported completing the relevant visit documented in a format adapted from another study. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and referrals.	At 4 weeks post-initial call
Number of Participants Enrolled/Eligible	The number of eligible participants will be tracked and for those not enrolled, reasons will be summarized. Will calculate the percent of participants who complete the follow-up visit to assess retention. Will also compare demographic characteristics and baseline scores of participants who complete the follow-up visit to those who do not via Fisher's exact tests or Wilcoxon rank sum tests as appropriate.	At 4 weeks post-initial call
Percentage of Assessments Completed	The percent of participants who complete the follow-up visit to assess retention. Will also compare demographic characteristics and baseline scores of participants who complete the follow-up visit to those who do not via Fisher's exact tests or Wilcoxon rank sum tests as appropriate.	At 4 weeks post-initial call
Number of Adverse Events Reported	The frequency of any adverse events will be reported.	At baseline (initial call) up to 4 weeks post-initial call

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Professional Practice; Organization and Administration; Health Services Administration; Referral and Consultation
• Other Study ID Numbers: IRB00119287; P30CA012197 (U.S. NIH Grant/Contract); ONC-LUN-2403 (Other Identifier: AHWFBCCC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No