Clinical trial NCT06654245: Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors
Official title: Toward an Integrated Approach to Assessing and Addressing Follow-Up Care Needs That Will Facilitate Care Transitions for Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage I Lung Cancer
Stage II Lung Cancer
Stage III Lung Cancer
Stage IV Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Exclusion Criteria: Does not meet the above inclusion criteria

Primary outcomes:
measure: SHAREDCare's Qualitative Acceptability
timeFrame: At 4 weeks post-initial call
Secondary outcomes:
measure: SHAREDCare's Quantitative Acceptability
timeFrame: At 4 weeks post-initial call
measure: SHAREDCare's Quantitative Appropriateness
timeFrame: At 4 weeks post-initial call
measure: SHAREDCare's Quantitative Feasibility
timeFrame: At 4 weeks post-initial call
measure: Number of Survivors With Unmet Needs
timeFrame: At baseline and at 4 weeks post-initial call
measure: Number of Clinical Referrals Made
timeFrame: At 4 weeks post-initial call
measure: Percentage of Referrals Completed
timeFrame: At 4 weeks post-initial call
measure: Number of Participants Enrolled/Eligible
timeFrame: At 4 weeks post-initial call
measure: Percentage of Assessments Completed
timeFrame: At 4 weeks post-initial call
measure: Number of Adverse Events Reported
timeFrame: At baseline (initial call) up to 4 weeks post-initial call
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC)
state: North Carolina
Study officials:
References: