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

NCT ID: NCT06654245

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2026-01-12

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telephone based interview

Intervention Type: BEHAVIORAL

Receive SHAREDCare navigator calls

Survey using a questionnaire.

Intervention Type: OTHER

Ancillary studies

Electronic health record review

Intervention Type: OTHER

Ancillary studies

Referral

Intervention Type: OTHER

Receive standard of care automated referrals

Interventions

Telephone based interview

Receive SHAREDCare navigator calls

Intervention Type: BEHAVIORAL

Survey using a questionnaire.

Ancillary studies

Intervention Type: OTHER

Electronic health record review

Ancillary studies

Intervention Type: OTHER

Referral

Receive standard of care automated referrals

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ONC-LUN-2403

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00119287

Identifier Type: -

Identifier Source: org_study_id