Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654245
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHAREDCare
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 patients 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 andor 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 ie 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 developdeploy 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
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 andor 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 ie 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 developdeploy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None