Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
This study is for Black and Latina women with metastatic breast cancer (cancer that has spread to other parts of the body). It aims to improve access to supportive care services, which can help with symptoms and quality of life. The study will test a program called ACCESS Supportive Care, which involves weekly coaching sessions with a community navigator. Another group will receive weekly phone sessions with information about resources. Researchers want to see if these programs are practical and helpful for participants. You can join if you are a woman over 18, speak English or Spanish, and have Stage IV breast cancer. The study plans to enroll 67 participants, but its current recruitment status is unclear.
- Study design
- This study is an interventional study that will randomize 60 participants into one of two groups to compare different supportive care approaches.
- What's involved
- If you join, you will either have 6 weekly coaching sessions with a community navigator or 6 weekly informational phone sessions, followed by monthly check-ins for 4 months. You will also complete questionnaires over the phone at the beginning, 6 months, and 9 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 9 months to measure recruitment, retention, and communication with the oncology team.
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Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Melissa Mazor · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of participants recruitedat 9 months
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
- Number of participants remaining in studyat 9 months
Acceptability evaluates if patients accept the intervention through a \<20% dropout rate at 9 months
- Number of times navigator communicates with oncology team9 months
Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time.
- Number of times participants connect to resources9 months
Integration evaluates if at least 80% of patients can connect to community and clinical resources.
- Number of visits6 months
Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include \> 80% of the visits conducted.
- Number of phone calls9 months
Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include \>80% of follow up phone calls conducted.
- Number of visits conducted according to the ACCESS manual9 months
Fidelity: This is indicated if \>80% of the visits are conducted according to the ACCESS manual.
- Change in The Impact of Event Scale - Revised (IES-R) scoresBaseline and 9 months
Cancer-related distress will be measured through the Impact of Event Scale - Revised (IES-R) is a 22-item instrument to assess distress. Each item is scored 0-4, with full scale from 0-22. Higher scores indicate greater severity of symptoms related to distress. Efficacy assessed by mean differences at 9 months as compared to baseline.
- Change in The Memorial Symptom Assessment Scale (MSAS)Baseline and 9 months
Symptom Burden will be measured through the Memorial Symptom Assessment (MSAS) is a 32 item instrument. Each item is scored from 0 to 4 with full scale from 0-128. A higher score indicates a greater level of symptom distress.