Intervention to Address Psychosocial Needs Among Socially Disadvantaged Older Adults With Cancer

Adapting Peer Connect to Train Lay Navigators in Delivering Psychosocial Support to Older Adults With Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Hematological Disorder
• Intervention / Treatment: Behavioral: Focus Group Discussions and Semi-structured Interviews; Behavioral: Training community lay navigators

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Lineberger Comprehensive Cancer Center, UNC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria to participate in the study:

1. Patients aged 65 and older diagnosed with hematological cancer for at least one year with stable disease

2. Community representative 18 years or older who also identifies as at least one of the following:

   1. Cancer caregivers
   2. Social workers, social work students, or patient navigators Community leader (e.g., leader of a faith-based organization)
   3. Previously or currently serve as a lay navigator/peer supporter, community health worker, or coach
   4. Have personal experience with any of the following (being Black race, previously or currently facing socioeconomic challenges, or living in a rural community)
   5. 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:

1. Inability to read and speak English
2. 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:

1. Inability to read and speak English
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Arm; Community representatives

Behavioral: Focus Group Discussions and Semi-structured Interviews; 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; Behavioral: Training community lay navigators; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Shakira Grant, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Psychosocial; older; Socially Disadvantaged; need
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: LCCC2240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No