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

NCT06654245 | Terminated

• 3 other identifiers: IRB00119287P30CA012197ONC-LUN-2403
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage I Lung Cancer; Stage II Lung Cancer; Stage III Lung Cancer; Stage IV Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• SHAREDCare's Quantitative Acceptability

  At 4 weeks post-initial call

• SHAREDCare's Quantitative Appropriateness

  At 4 weeks post-initial call

• SHAREDCare's Quantitative Feasibility

  At 4 weeks post-initial call

• Number of Survivors With Unmet Needs

  At baseline and at 4 weeks post-initial call

• Number of Clinical Referrals Made

  At 4 weeks post-initial call

Study Arms (1)

SHAREDCare Supportive care arm

EXPERIMENTAL

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; Other: Survey using a questionnaire.; Other: Electronic health record review; Other: Referral

Interventions

Telephone based interview BEHAVIORAL

Receive SHAREDCare navigator calls

SHAREDCare Supportive care arm

Survey using a questionnaire. OTHER

Ancillary studies

SHAREDCare Supportive care arm

Electronic health record review OTHER

Ancillary studies

SHAREDCare Supportive care arm

Referral OTHER

Receive standard of care automated referrals

SHAREDCare Supportive care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC)

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

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

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: June 11, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)