60 Participants Needed

Supportive Services for Breast Cancer

(ACCESS Trial)

MM
Overseen ByMelissa Mazor
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai

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 ACCESS Supportive Care, Phone sessions, Lynparza, AZD-2281, MK-7339, KU0059436 for breast cancer?

Supportive care, which includes services like ACCESS Supportive Care and Phone sessions, has been shown to improve the quality of life and manage symptoms for cancer patients, including those with breast cancer. This type of care helps address physical, emotional, and practical needs, which can lead to better overall health outcomes.12345

Is the treatment generally safe for humans?

The research articles provided do not contain specific safety data for the treatment known as ACCESS Supportive Care, Phone sessions, Lynparza, AZD-2281, MK-7339, or KU0059436. Therefore, no relevant safety information is available from these sources.678910

How does the ACCESS Supportive Care treatment for breast cancer differ from other treatments?

ACCESS Supportive Care is unique because it focuses on addressing the comprehensive needs of breast cancer patients, including managing treatment-related symptoms like fatigue and pain, and providing educational, psychosocial, and spiritual support. This approach aims to improve adherence to treatment and enhance the overall quality of life, which is often overlooked in standard cancer treatments.15111213

What is the purpose of this trial?

Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.

Research Team

MM

Melissa Mazor

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.
I was diagnosed with metastatic breast cancer within the last 5 years.
Self-identify as Latina and/or African American/Black
See 1 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ACCESS Supportive CareExperimental Treatment1 Intervention
Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care
Group II: Attention ControlPlacebo Group1 Intervention
Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .

Find a Clinic Near You

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+

Findings from Research

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

References

Prevalence, intensity, and predictors of the supportive care needs of women diagnosed with breast cancer: a systematic review. [2018]
Supportive Care: The "Keystone" of Modern Oncology Practice. [2023]
Improving quality of life and symptom experience in patients with metastatic breast cancer: A systematic review of supportive care interventions. [2023]
Leveling the playing field: the personal coach program as an innovative approach to assess and address the supportive care needs of underserved cancer patients. [2007]
Models of supportive care in oncology. [2023]
The impact of outpatient chemotherapy-related adverse events on the quality of life of breast cancer patients. [2022]
Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. [2021]
Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]
Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]
A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]
Supportive care during treatment for breast cancer: resource allocations in low- and middle-income countries. A Breast Health Global Initiative 2013 consensus statement. [2021]
[Supportive care for urological metastatic patients]. [2008]
Inequalities and Barriers to the Use of Supportive Care Among Young Breast Cancer Survivors: a Qualitative Understanding. [2018]
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