Back to resultsIntervention to Address Psychosocial Needs Among Socially Disadvantaged Older Adults With Cancer
Primary Purpose
Hematological Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus Group Discussions and Semi-structured Interviews
Training community lay navigators
Sponsored by
About this trial
This is an interventional health services research trial for Hematological Disorder focused on measuring Socially Disadvantaged, older, Psychosocial, need
Eligibility Criteria
Inclusion criteria to participate in the study: Patients aged 65 and older diagnosed with hematological cancer for at least one year with stable disease Community representative 18 years or older who also identifies as at least one of the following: Cancer caregivers Social workers, social work students, or patient navigators Community leader (e.g., leader of a faith-based organization) Previously or currently serve as a lay navigator/peer supporter, community health worker, or coach Have personal experience with any of the following (being Black race, previously or currently facing socioeconomic challenges, or living in a rural community) Patient or community representative who is Able to understand and speak in English Exclusion Criteria All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: Inability to read and speak English Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Exclusion Criteria All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: Inability to read and speak English Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Sites / Locations
- Lineberger Comprehensive Cancer Center, UNC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Community representatives
Outcomes
Primary Outcome Measures
Adaptation of the existing Peer Connect training materials- interviews
Through semi-structured interviews, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Adaptation of the existing Peer Connect training materials- focus group discussions
Through focus group discussions, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Secondary Outcome Measures
Training community lay navigators- training sessions
The ability to train community lay navigators using the newly adapted training content- training sessions will be assessed by the number of training sessions completed by lay navigators and the research staff, allowing for sharing of broad perspectives on training methods, content, and delivery.
Training community lay navigators - semi-structured interviews
The ability to train community lay navigators using the newly adapted training content will be assessed through qualitative semi-structured interviews with lay navigators and the research staff, allowing for sharing of broad perspectives on training methods, content, and delivery.
Full Information
NCT ID
NCT05828654
First Posted
March 27, 2023
Last Updated
October 10, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05828654
Brief Title
Intervention to Address Psychosocial Needs Among Socially Disadvantaged Older Adults With Cancer
Official Title
Adapting Peer Connect to Train Lay Navigators in Delivering Psychosocial Support to Older Adults With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Investigator left the institution.
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
September 28, 2023 (Actual)
Study Completion Date
September 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to convene a group of diverse North Carolina-based community representatives (patients, caregivers, leaders of faith-based organizations, social workers, and patient navigators) to inform the adaptation of materials used to train lay navigators in the delivery of psychosocial support interventions tailored to older socially disadvantaged adults with cancer.
Detailed Description
This behavioral study will explore community representatives' perspectives on the resources and training needed to support the development of a lay navigation program tailored to older socially disadvantaged adults with cancer.
It was hypothesized that diverse community representatives could inform the adaptation of training materials (Peer Connect) and subsequent training of community lay navigators, who will then be positioned to address the psychosocial needs of older adults with cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Disorder
Keywords
Socially Disadvantaged, older, Psychosocial, need
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Community representatives
Intervention Type
Behavioral
Intervention Name(s)
Focus Group Discussions and Semi-structured Interviews
Intervention Description
Community representatives will be asked to participate in either 1:1 semi-structured interviews with a research staff member or to engage in focus group discussions with other community members. These interviews and discussions will gather broad perspectives on resource and training needs for community lay navigators and inform the adaptation of existing Peer Connect training materials
Intervention Type
Behavioral
Intervention Name(s)
Training community lay navigators
Intervention Description
Lay navigators identified from among the recruited community representatives will be trained either in-person or virtually by research staff members in motivational interviewing and other strategies to provide psychosocial support to older socially disadvantaged adults with cancer. For community lay navigators and inform the adaptation of existing Peer Connect training materials.
Primary Outcome Measure Information:
Title
Adaptation of the existing Peer Connect training materials- interviews
Description
Through semi-structured interviews, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Time Frame
12 months
Title
Adaptation of the existing Peer Connect training materials- focus group discussions
Description
Through focus group discussions, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Training community lay navigators- training sessions
Description
The ability to train community lay navigators using the newly adapted training content- training sessions will be assessed by the number of training sessions completed by lay navigators and the research staff, allowing for sharing of broad perspectives on training methods, content, and delivery.
Time Frame
12 months
Title
Training community lay navigators - semi-structured interviews
Description
The ability to train community lay navigators using the newly adapted training content will be assessed through qualitative semi-structured interviews with lay navigators and the research staff, allowing for sharing of broad perspectives on training methods, content, and delivery.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria to participate in the study:
Patients aged 65 and older diagnosed with hematological cancer for at least one year with stable disease
Community representative 18 years or older who also identifies as at least one of the following:
Cancer caregivers
Social workers, social work students, or patient navigators Community leader (e.g., leader of a faith-based organization)
Previously or currently serve as a lay navigator/peer supporter, community health worker, or coach
Have personal experience with any of the following (being Black race, previously or currently facing socioeconomic challenges, or living in a rural community)
Patient or community representative who is Able to understand and speak in English
Exclusion Criteria
All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:
Inability to read and speak English
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Exclusion Criteria
All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:
Inability to read and speak English
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakira Grant, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Learn more about this trial
Intervention to Address Psychosocial Needs Among Socially Disadvantaged Older Adults With Cancer
We'll reach out to this number within 24 hrs