Doula Support Program for Advanced Cancer

(Doulas-AC Trial)

Overseen By Ella Choban, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Live outside Pittsburgh

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support Black patients with advanced cancer in the Pittsburgh area by partnering them with a trained doula, a caregiver who offers emotional and practical support. The goal is to help patients find meaning and create a legacy while assisting with daily challenges like financial aid, transportation, and accessing medications. The doula also supports families and friends, connecting them to community resources for health and mental well-being. This trial suits Black individuals with stage IV cancer living in or near Pittsburgh. As an unphased trial, it offers a unique opportunity for patients to receive personalized support and resources tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for patients with advanced cancer?

Research shows that having a doula is generally safe and helpful. Doulas, as non-medical companions, enhance patients' care experiences by reducing stress and providing emotional support. For instance, studies on doula programs in maternal care have found benefits such as fewer cesarean sections and improved overall experiences.

This specific doula program targets patients with advanced cancer but applies similar care principles. Patients meet with a trained doula once a week. This approach is non-invasive, involving no medical procedures or drugs. Reports of negative effects in doula care are rare because the focus remains on emotional and practical support, not medical treatment. Overall, the doula program is designed to be safe and supportive, with no known safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for advanced cancer, which mainly focus on medical interventions like chemotherapy and radiation, the Doula Support Program offers a unique approach by integrating emotional and social support into patient care. This program pairs patients with a doula who provides personalized, empathetic engagement, dedicating four hours each week to support the patient's emotional and psychological needs. Researchers are excited because this approach may enhance the quality of life and overall well-being for patients, potentially reducing stress and improving their ability to cope with the challenges of cancer treatment.

What evidence suggests that the Doula Support Program is effective for advanced cancer patients?

Research has shown that doula programs can greatly assist patients with complex health issues. While most studies have focused on pregnancy outcomes, the benefits of having a doula extend beyond childbirth. For instance, patients with doula support often experience less stress and improved emotional health. In cancer care, similar support programs have shown promise in enhancing patients' quality of life. In this trial, participants will engage with a doula for four hours per week. The doula will help with practical needs such as attending appointments and accessing medication, while also providing emotional support and fostering a sense of community. ^{1 6 7 8 9}

Who Is on the Research Team?

Margaret Quinn Rosenzweig, PhD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants must reside in or around Pittsburgh, Pennsylvania area

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

Participants must be of African American race

Exclusion Criteria

Inability to read or understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Doula-Patient Engagement

Four hours/week of Ubuntu ambassador/Doula and Patient engagement. The nature and type of visits will be determined by the patient and doula.

24 weeks

Weekly visits

Follow-up

Participants are monitored for changes in Integrated Palliative care Outcome Scale (IPOS) and the acceptability and feasibility of the Doula Program

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DOULA-AC 1

Trial Overview

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.

How Is the Trial Designed?

Group I: Doula-Patient engagement Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

The ENABLE palliative care model was found to be culturally acceptable among patients with advanced cancer and their caregivers in Singapore, highlighting the need for psychosocial support earlier in the illness trajectory.

Participants recommended modifications to the program, such as ensuring content is suitable for patients who may not fully understand their diagnosis and preferring face-to-face sessions to enhance rapport with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. Yang, GM., Dionne-Odom, JN., Foo, YH., et al.[2021]

Young mothers with cancer prioritize protecting their children's psychological well-being during their treatment journey, employing strategies like customizing exposure to their illness and reducing family disruptions.

The study highlights the need for oncology nurses to understand these mothers' unique challenges, as the 'Safeguarding the Children' model can help them provide better support and resources tailored to the needs of young mothers facing cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safeguarding the Children: The Cancer Journey of Young Mothers. Strickland, JT., Foley Wells, C., Porr, C.[2015]

Only 41.6% of adults affected by cancer accessed supportive care programming during the COVID-19 pandemic, but many of those who did felt they had similar or better access compared to before the pandemic, highlighting the potential benefits of online delivery.

Despite the advantages of online programming, over half (56.6%) of participants expressed apprehension about returning to in-person supportive care, indicating a need for safety protocols to help them feel comfortable gathering again.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Describing Supportive Care Programming Access and Comfort Gathering through the COVID-19 Pandemic: An Observational Mixed Methods Study with Adults Affected by Cancer. Wurz, A., Janzen, A., Ellis, K., et al.[2023]

A study involving 21 couples facing advanced cancer revealed significant parenting concerns, with 62% reporting family distress and 29% marital distress, highlighting the emotional impact of cancer on family dynamics.

Both patients and spouses expressed a strong desire for parenting-related support, with preferences for self-led resources and counseling, indicating a need for tailored interventions that address practical and emotional challenges in co-parenting during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living With an Advanced Cancer While Parenting Minor Children: A Needs Assessment Study. Whisenant, M., Jones, M., Ann-Yi, S., et al.[2023]

Approximately 24.7% of cancer patients are parents of children under 18, and this group faces unique challenges that can lead to a decreased quality of life compared to other cancer patients and the general population.

An integrative review of nine studies highlights the need for healthcare providers to conduct comprehensive assessments of parental cancer patients to better address their specific psychosocial and emotional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life in Adult Cancer Patients With Underage Children: An Integrative Review. Mota-George, G., Martinez, A., Dains, JE.[2023]

Caregivers of women with advanced breast cancer face significant psychosocial challenges, especially during the terminal phase of the disease, with non-spouse caregivers experiencing the most difficulties due to managing multiple life roles.

Spouse caregivers benefit from living with the patient, which facilitates caregiving and shared decision-making, while non-spouse caregivers often struggle to meet the patient's needs and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiving for women with advanced breast cancer. Coristine, M., Crooks, D., Grunfeld, E., et al.[2022]

The management of advanced breast cancer has evolved to focus not only on treatment but also on the comprehensive needs of patients and caregivers, emphasizing a multidisciplinary approach that includes physical, psychological, and social support.

There is a critical need for targeted clinical research to address the unique survivorship challenges faced by different patient groups, including young and elderly women and male patients, to ensure their specific psychosocial needs are met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it time to address survivorship in advanced breast cancer? A review article. Di Lascio, S., Pagani, O.[2022]

A study involving 23 participants with advanced cancer revealed that while psychosocial support is crucial for improving their quality of life, many faced barriers in accessing appropriate care, including stigma and lack of awareness.

Participants highlighted the importance of tailored psychosocial support services, indicating that healthcare providers need to address accessibility issues to better meet the diverse needs of patients living with advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of psychosocial support in the experiences of people living with advanced cancer: A qualitative exploration of patients' perspectives. Newton, JC., O'Connor, M., Saunders, C., et al.[2021]

A novel parent support program for advanced cancer patients and their spouses showed promising feasibility, with a 61% consent rate and high attendance (90%) at all sessions, indicating strong engagement with the intervention.

Significant improvements were observed in parenting concerns and efficacy for both patients and spouses at six and twelve weeks post-intervention, suggesting that the program may effectively reduce psychological distress and enhance parenting skills in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care for Dual Caregivers who Care for Their Partner With Cancer and Their Young Children. Ann-Yi, S., Milbury, K., Jones, M., et al.[2023]

Interventions designed to support family caregivers of patients with advanced cancer, including psychosocial and educational approaches, have shown significant benefits in reducing psychological distress and caregiving burden, while also improving caregivers' quality of life and self-efficacy.

Despite the positive outcomes observed in most studies, there is a notable lack of research focusing on the physical health of caregivers, and further studies are needed to evaluate the long-term efficacy of these interventions and to use standardized measures for better comparison.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions for family caregivers who care for patients with advanced cancer at home. Ahn, S., Romo, RD., Campbell, CL.[2021]

Citations

1.

withpower.com

withpower.com/trial/phase-metastatic-breast-cancer-5-2022-7667b

Doula Support Program for Advanced Cancer · Info ...

While not directly about DOULA-AC 1, these findings suggest that support programs like DOULA-AC 1 could be beneficial for advanced cancer patients who are also ...

2.

pcori.org

pcori.org/research-results/2023/comparing-effectiveness-doula-care-reducing-severe-maternal-morbidity

Comparing the Effectiveness of Doula Care for Reducing ...

This study compares the clinical effectiveness of doula care utilization on pregnancy care and health outcomes after childbirth.

3.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00261-9/fulltext

Evaluation of doula programs across three states using ...

Women who received doula care during labor and birth, but not necessarily during pregnancy, showed a 64.7% reduction in odds of PPA/PPD (OR: 0.353 95% CI: 0.16– ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0266613825000361

Creating a doula support program for pregnant teens using ...

We describe the application of these methods to create a comprehensive doula program to support pregnant teens.

5.

pittmed.pitt.edu

pittmed.pitt.edu/high-touch-multipronged-approaches-breast-cancer-nurses-doula-program

What does the patient really need? | Pitt Med Magazine

A doula program gives breast cancer patients physical and emotional support. ... Rosenzweig's team is still assessing the effectiveness of the doula program ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38724343/

United States Doula Programs and Their Outcomes

Data on outcomes related to doula care in the literature were predominantly clinical, even though doulas are not clinical providers. Although ...

7.

researchgate.net

researchgate.net/publication/271224307_How_Doula_Care_Can_Advance_the_Goals_of_the_Affordable_Care_Act_A_Snapshot_From_New_York_City

(PDF) How Doula Care Can Advance the Goals of ...

Doula care meets each of the triple aims of the Affordable Care Act: improving health outcomes for all, improving the experience of care, and ...

8.

aspe.hhs.gov

aspe.hhs.gov/sites/default/files/documents/dfcd768f1caf6fabf3d281f762e8d068/ASPE-Doula-Issue-Brief-12-13-22.pdf

Doula Care and Maternal Health: An Evidence Review

A randomized control trial on doula home visit services found women who received doula services were more likely than women enrolled in case ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10292163/

The Effect of Doulas on Maternal and Birth Outcomes

The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced cesarean sections.