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

Wake Forest University (WFU)

Status

Enrolling

Conditions

Stage III Lung Cancer

Stage II Lung Cancer

Stage IV Lung Cancer

Stage I Lung Cancer

Treatments

Other: Electronic health record review

Behavioral: Telephone based interview

Other: Survey using a questionnaire.

Other: Referral

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06654245

P30CA012197 (U.S. NIH Grant/Contract)

IRB00119287

ONC-LUN-2403 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria: Does not meet the above inclusion criteria