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Doula Support Program for Advanced Cancer (Doulas-AC Trial)

N/A

Recruiting

Led By Margaret Quinn Rosenzweig, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients diagnosed with Metastatic Breast Cancer

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will provide support for black patients with advanced cancer in the form of a trained companion, help with exploring legacy and meaning, and practical assistance. After death, the program will also support bereaved family and friends.

Who is the study for?

This trial is for African American individuals living in or near Pittsburgh, Pennsylvania who have been diagnosed with Metastatic Breast Cancer. Participants must be able to read and understand English.

What is being tested?

The 'Doulas - AC' program aims to provide a trained companion for patients with advanced cancer, focusing on dignity, legacy creation, practical support for illness needs, and bereavement support for family/friends.

What are the potential side effects?

Since this intervention involves supportive care rather than medical treatment, there are no direct physical side effects; however emotional distress may arise from discussing end-of-life issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with breast cancer that has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability and feasibility of the Doula Program

Change in Integrated Palliative care Outcome Scale (IPOS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Doula-Patient engagementExperimental Treatment1 Intervention

Four hours/week of Ubuntu ambassador/Doula and Patient engagement. The nature and type of visits will be determined by the patient and doula. The doula will formulate weekly reports for each assigned patient. Weekly progress reporting - Weeks 2- 24.

0 / 1Eligibility criteria met