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Trial Title:
Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors
NCT ID:
NCT06654245
Condition:
Stage I Lung Cancer
Stage II Lung Cancer
Stage III Lung Cancer
Stage IV Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Telephone based interview
Description:
Receive SHAREDCare navigator calls
Arm group label:
SHAREDCare Supportive care arm
Intervention type:
Other
Intervention name:
Survey using a questionnaire.
Description:
Ancillary studies
Arm group label:
SHAREDCare Supportive care arm
Intervention type:
Other
Intervention name:
Electronic health record review
Description:
Ancillary studies
Arm group label:
SHAREDCare Supportive care arm
Intervention type:
Other
Intervention name:
Referral
Description:
Receive standard of care automated referrals
Arm group label:
SHAREDCare Supportive care arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC)
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Start date:
January 31, 2025
Completion date:
July 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654245
