Dignity, Legacy, Advocacy, and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community (Doulas-AC)

Dignity, Legacy, Advocacy, and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community (Doulas - AC)

The proposed program, "Doulas - AC" will provide Dignity, Legacy, Advocacy and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community." The goals are to: 1) provide a community-based, trained companion to journey alongside the patient with advanced cancer, 2) to help the individual explore meaning and create legacy, 3); offer support and navigation for practical needs of illness (e.g., financial assistance for food and housing, accessing and affording medications, transportation); and 4) to provide support and connection for the bereaved family/friends, including facilitating community connections for routine health screenings and access to mental health services, as needed.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: DOULA-AC 1

Detailed Description

The patient will be contacted and consent will be obtained by telephone. Once consent is obtained, the doula will be contacted with the patient information.

The doula will then contact the patient and determine how the 3 hours/week will be sent.

The doula will be trained by the study PI. The protocols for patient engagement will be taught. At the conclusion of the training, the doula that successfully work with standardized patients will be asked to work through the protocols for each clinic visit.

The options of emotional support, practical assistance, family support, and legacy building projects will be offered. The nature and type of visits will be determined by the patient and doula. A weekly plan will be implemented by the doula which may involve conversations, creating legacy projects, conversations with family and patients, and assistance with practical issues. Following completion of data collection, descriptive statistics will be utilized to evaluate % change in patient outcomes from baseline to 2 months and study completion. Implementation outcomes will be quantified.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Plassmeyer, MS; Phone Number: 412-648-6417; Email: plassmeyerjm@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • UPMC Hillman Cancer Center
      • Contact: Joshua Plassmeyer, MS; Phone Number: 412-648-6417; Email: plassmeyerjm@upmc.edu
      • Principal Investigator: Margaret Quinn Rosen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients diagnosed with Metastatic Breast Cancer
2. Participants must be of African American race
3. Participants must reside in or around Pittsburgh, Pennsylvania area

Exclusion Criteria:

1. Inability to read or understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DOULA -AC; Four hours/week of Doula and Patient engagement.	Behavioral: DOULA-AC 1; Doula and Patient will decide on details of engagement. The components to be included will be: 1) emotional support, 2)practical assistance, 3) family support, and/or 4)legacy building projects as per study protocols. The nature and type of visits will be determined by the patient and doula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interpersonal Support Evaluation List (ISEL)	The Interpersonal Support Evaluation List (ISEL) is a 40-item scale comprised of four subscales: 1.) Tangible Support; 2.) Belonging Support; 3.) Self-esteem Support; 4.) Appraisal Support. Items are rated by participants on how true or false they believe the statements are for themselves. Answers are given on a 4-point scale ranging from 0-3: definitely false (0), probably false (1), probably true (2), definitely true (3). The ISEL is scored by summing the items to create an overall score that indicates a participant's perceived level of social support. Total scores (total of all subscales) range from 0-120. Higher ISEL scores indicate greater ability to endure stressful experiences and greater perceived social support.	Baseline, up to 6 months
Change in Hospital Anxiety and Depression Scale (HADS)	The HADS questionnaire is a self-assessment questionnaire detecting states of anxiety and depression that includes 7 items each for depression and anxiety subscales. Scoring for each item ranges from 0 - 3. Scores of 3 for a single item denotes highest anxiety or depression level. Total overall scores (total of all subscales) range from 0 - 21. A total score of 8 or more points out of a possible 21 indicates considerable symptoms of anxiety or depression.	Baseline, up to 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Questionnaire	The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a short form assessment that uses a single 0-10 numeric pain rating item and seven health domains using four items each. The seven domains included Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. It also includes plus one pain intensity question. Total raw scores range from 0 - 290. Higher PROMIS scores indicate more severe effect of pain on domain items and on quality of life.	Baseline, up to 6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Margaret Quinn Rosenzweig, PhD, UPMC Hillman Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: doula
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: HCC 21-265

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
• product manufactured in and exported from the U.S.: No