Health TrialsbyHealthPanel

Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

ConditionsMetastatic Breast CancerStage IV Breast Cancer AJCC V7
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women ≥18 years of age

English and/or Spanish speaking

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

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

Disqualifiers

Moderate to severe cognitive impairment

receiving inpatient hospice care

if patients were previously enrolled in Aim 1 and Aim 2

currently working with a community navigator

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACCESS Supportive Care

    Behavioral

    ACCESS Supportive Care includes: 1. Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference. 2. Monthly check-in: Monthly check-ins (\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. 3. Scheduling of outpatient supportive oncology appointment if interested. 4. Community linkage: Warm hand offs and connection to community resources to enhance access to support groups, educational workshops, and healthy lifestyle services.

  • Phone sessions

    Behavioral

    6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (\~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.

Treatment groups

67 Participants
are divided into 2 treatment groups
Group A: ACCESS Supportive CareExperimental treatment 1 intervention
Group B: Attention ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants recruited

Acceptability evaluates if patients accept the intervention through the ability to recruit 60 participants in 1.5 years and a \<20% dropout rate at 9 months

Time frame
at 9 months
2

Number of participants remaining in study

Acceptability evaluates if patients accept the intervention through a \<20% dropout rate at 9 months

Time frame
at 9 months
3

Number of times navigator communicates with oncology team

Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time.

Time frame
9 months
4

Number of times participants connect to resources

Integration evaluates if at least 80% of patients can connect to community and clinical resources.

Time frame
9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now