Supportive Services for Breast Cancer

(ACCESS Trial)

Overseen By Melissa Mazor

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cognitive impairment, Inpatient hospice, others

Compensation: Varies

Number of Visits: 6

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve supportive care for Black and Latina women with advanced breast cancer. Researchers will test a program called ACCESS Supportive Care, which includes assistance from a community navigator. The trial seeks to determine if this support is practical and well-received. Women who self-identify as Black or Latina, speak English or Spanish, and have stage IV breast cancer may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance supportive care for future patients.

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 the ACCESS Supportive Care intervention is safe?

In a previous study, researchers explored how supportive care can assist patients with breast cancer. Although the study did not directly focus on safety, it emphasized the importance of meeting patients' needs. Supportive care, such as the ACCESS program, aims to enhance quality of life.

The ACCESS Supportive Care treatment is neither a drug nor a medical procedure. Instead, it connects patients with a navigator who guides them through their care. This approach is generally well-received because it focuses on providing help and emotional support rather than medical treatment. No harmful side effects are known from this type of support.

Overall, supportive care methods have been used safely in many situations. They are designed to help, not harm. In this trial, the goal is to assist Black and Latina women with breast cancer in accessing the care they need. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACCESS Supportive Care protocol for breast cancer because it offers a personalized approach that connects participants with a navigator for tailored support. Unlike standard treatments focusing purely on medical interventions, ACCESS emphasizes holistic care, potentially enhancing patients' quality of life and emotional well-being. This method could fill a gap in current care by addressing the broader needs of patients beyond just the physical symptoms of breast cancer.

What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?

Research has shown that the ACCESS Supportive Care program, available to participants in this trial, may address certain needs for women with advanced breast cancer, particularly in resource-limited communities. While it did not significantly enhance overall quality of life in some studies, participants reported greater satisfaction with their care compared to standard treatments. Some studies also found improved management of symptoms such as fatigue and hot flashes, though results varied. The program connects patients with community guides to help them access necessary care and support. Overall, it aims to make healthcare more accessible and satisfactory for those who often encounter challenges in obtaining the care they need. ^{2 5 6 7 8}

Who Is on the Research Team?

Melissa Mazor

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for women over 18 who identify as Latina or African American/Black, speak English or Spanish, and have been diagnosed with metastatic breast cancer within the last 5 years. They must be able to consent to the study. Women with moderate to severe cognitive issues, in hospice care, or already working with a community navigator can't join.

Inclusion Criteria

I am a woman aged 18 or older.

Self-identify as Latina and/or African American/Black

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

Currently working with a community navigator

Patients previously enrolled in Aim 1 and Aim 2

I am currently receiving care in a hospice.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator

6 months

6 sessions (in-person or virtual)

Follow-up

Participants receive monthly phone call check-ins for 4 months and complete questionnaires at baseline, 6 months, and 9 months

4 months

Monthly phone calls

Long-term Follow-up

Participants are monitored for changes in symptom burden and cancer-related distress, with assessments at baseline and 9 months

9 months

What Are the Treatments Tested in This Trial?

Interventions

• ACCESS Supportive Care
• Phone sessions

Trial Overview The study tests a supportive care intervention delivered by community navigators for underserved Black and Latina women with metastatic breast cancer. It involves evaluating how feasible and acceptable this approach is through ACCESS Supportive Care and phone sessions.

How Is the Trial Designed?

Group I: ACCESS Supportive Care Experimental Treatment 1 Intervention

Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care

Group II: Attention Control Placebo Group 1 Intervention

Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 62 phase III breast cancer chemotherapy trials revealed that 66% did not report details on prophylactic antiemetic treatments, indicating a significant gap in supportive care documentation.

The lack of reporting on supportive care interventions, such as growth factors and antibiotics, could negatively affect patient management and increase healthcare costs, highlighting the need for better guidelines in clinical trial reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. Freedman, O., Amir, E., Zimmermann, C., et al.[2021]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

Breast cancer patients often have unmet supportive care needs during treatment, including managing treatment-related symptoms and addressing educational, psychosocial, and spiritual concerns, especially in low- and middle-income countries.

The consensus statement from the 5th Breast Health Global Initiative outlines twelve key recommendations for supportive care, emphasizing the importance of resource-stratified approaches to improve patient adherence to treatment and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care during treatment for breast cancer: resource allocations in low- and middle-income countries. A Breast Health Global Initiative 2013 consensus statement. Cardoso, F., Bese, N., Distelhorst, SR., et al.[2021]

A review of 23 studies on breast cancer patients revealed that their most pressing supportive care needs are psychological and informational, particularly the fear of cancer recurrence, highlighting the importance of addressing these concerns to improve quality of life.

Predictors of higher unmet needs included advanced disease stage, greater symptom burden, and younger age, suggesting that targeted interventions should focus on these groups to effectively support breast cancer patients throughout their treatment and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence, intensity, and predictors of the supportive care needs of women diagnosed with breast cancer: a systematic review. Fiszer, C., Dolbeault, S., Sultan, S., et al.[2018]

A study involving 36 young breast cancer survivors in France revealed significant barriers to accessing supportive care services, particularly due to inadequate information delivery that does not meet patients' needs.

Improving the organization and communication of information about supportive care could help reduce inequalities in access and enhance the quality of life for cancer survivors, especially among socially deprived individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inequalities and Barriers to the Use of Supportive Care Among Young Breast Cancer Survivors: a Qualitative Understanding. Regnier Denois, V., Querre, M., Chen, L., et al.[2018]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

Supportive cancer care encompasses comprehensive assistance for patients, including pain management, psychological support, and access to therapies, which is crucial for improving quality of life during treatment.

In France, the establishment of supportive care centers in hospitals aims to enhance coordination among multidisciplinary teams, particularly benefiting patients with bone metastasis through tailored interventions like bisphosphonates and physiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. Lebret, T., Di Palma, M., Ripoll, J., et al.[2008]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

A study of 48 breast cancer patients showed that their quality of life significantly decreased after the first course of outpatient chemotherapy, as measured by both the European Quality of Life 5 Dimensions and the Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs.

Patients experiencing anorexia reported a greater decline in quality of life compared to those without anorexia, highlighting the significant impact of this adverse event on overall well-being during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of outpatient chemotherapy-related adverse events on the quality of life of breast cancer patients. Tachi, T., Teramachi, H., Tanaka, K., et al.[2022]

Supportive care for cancer patients addresses a wide range of needs—physical, emotional, social, spiritual, and informational—throughout their treatment journey, highlighting the importance of interdisciplinary teams in delivering comprehensive care.

Current referral models for supportive care can lead to inconsistent access and fragmented services; the proposed integrated framework suggests organizing these services under one department to improve collaboration, streamline care, and enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of supportive care in oncology. Hui, D., Hoge, G., Bruera, E.[2023]

Supportive care in cancer, as defined by the MASCC, plays a crucial role in managing the physical and psychological effects of cancer and its treatments, aiming to enhance quality of life throughout the entire cancer journey.

Evidence suggests that supportive care not only improves patient morbidity and quality of life but also has potential health economic benefits, highlighting its importance in cancer treatment and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care: The "Keystone" of Modern Oncology Practice. Scotté, F., Taylor, A., Davies, A.[2023]

The Personal Coach Program (PCP) was piloted with 63 cancer patients facing significant barriers such as language, poverty, and social isolation, and it successfully identified and addressed their unmet supportive care needs.

Participants reported high satisfaction with the PCP, believing it positively impacted their physical and emotional health, highlighting the importance of tailored supportive care for underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveling the playing field: the personal coach program as an innovative approach to assess and address the supportive care needs of underserved cancer patients. Hohenadel, J., Kaegi, E., Laidlaw, J., et al.[2007]

A systematic review of 13 studies on supportive care interventions for individuals with metastatic breast cancer (MBC) found that multimodal approaches, particularly those including physical activity, can significantly improve quality of life and symptom experience.

Despite some positive outcomes, the studies were highly varied in their methods and results, indicating a need for more standardized research to better understand the most effective supportive care strategies for MBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving quality of life and symptom experience in patients with metastatic breast cancer: A systematic review of supportive care interventions. Keane, D., Phillips, G., Mitchell, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11398295/

Impact of a Multidisciplinary Supportive Care Model Using ... The ACCESS program did not significantly improve QoL (primary outcome). However, compared with usual care recipients, ACCESS recipients reported ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000478

Evidence-based digital health interventions for breast ... Three pre-post studies presented significant improvements in fatigue and hot flushes after the intervention but three RCTs presented no significant changes ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/13696998.2020.1858580

Evaluation of access to care issues in patients with breast ... This study examined access to care in a population of women with breast cancer and its relationship to overall patient satisfaction.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318393/

Unmet supportive care need and associated factors among ... The most prevalent unmet supportive care needs were physical needs (61.6%) and health system needs (62.4%). Logistic regression analysis ...

5. nature.com nature.com/articles/s44276-025-00172-z

Hidden costs and unmet supportive care needs among ... 470 and 136 participants reported primary (PBC) and metastatic (MBC) breast cancer, respectively. 27% PBC and 35% MBC participants reported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12564611/

Supportive Care Needs of Patients with Breast Cancer ... Our findings highlight the desire for greater access to disaggregated data on treatment effectiveness, clinical outcomes, and treatment ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624000079

The time for harnessing electronic patient-reported ... Seizing the moment: The time for harnessing electronic patient-reported outcome measures for enhanced and sustainable metastatic breast cancer care is now.

8. ajmc.com ajmc.com/view/breast-cancer-dominating-oncology-research-access-disparities-gen-li-phd

Breast Cancer Dominating Oncology Research, Access ... An older report from Phesi noted that only 14% of breast cancer trials met optimal enrollment rates. This is likely due to a lack of awareness ...