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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment DOULA-AC 1 for advanced cancer?

The research highlights the importance of supportive care for cancer patients with young children, indicating that addressing parenting concerns and psychological distress can improve quality of life. 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 parents. ^{1 2 3 4 5}

How does the Doula Support Program for Advanced Cancer differ from other treatments for this condition?

The Doula Support Program for Advanced Cancer is unique because it focuses on providing emotional and psychosocial support, rather than medical treatment, to patients and their families. This approach addresses the complex needs of patients by offering support in social, psychological, and spiritual domains, which is different from traditional medical treatments that primarily focus on physical symptoms. ^{6 7 8 9 10}

What is the purpose of this trial?

The program will provide Advocacy and Support for Black patients with advanced-stage cancer in the Pittsburgh area. 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.

Research Team

Margaret Quinn Rosenzweig, PhD

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

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

Participants must be of African American race

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

Exclusion Criteria

Inability to read or understand English

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safeguarding the Children: The Cancer Journey of Young Mothers. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Supportive Care for Dual Caregivers who Care for Their Partner With Cancer and Their Young Children. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

A systematic review of interventions for family caregivers who care for patients with advanced cancer at home. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Living With an Advanced Cancer While Parenting Minor Children: A Needs Assessment Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Quality of Life in Adult Cancer Patients With Underage Children: An Integrative Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Caregiving for women with advanced breast cancer. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Is it time to address survivorship in advanced breast cancer? A review article. [2022]

8. Switzerland 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. [2021]

10. England 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. [2021]