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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA267309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objectives:
OUTLINE: Participants (N=60) are randomized to 1 of 2 groups:
GROUP 1/Intervention Group: Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months.
GROUP 2/Attention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCESS Supportive Care | Experimental | Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care |
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| Attention Control | Placebo Comparator | Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCESS Supportive Care | Behavioral | ACCESS Supportive Care includes:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 9 months |
| Number of participants remaining in study | Acceptability evaluates if patients accept the intervention through a <20% dropout rate at 9 months | at 9 months |
| 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. | 9 months |
| Number of times participants connect to resources | Integration evaluates if at least 80% of patients can connect to community and clinical resources. | 9 months |
| Number of visits | Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include > 80% of the visits conducted. | 6 months |
| Number of phone calls | 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. | 9 months |
| Number of visits conducted according to the ACCESS manual |
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Inclusion Criteria:
Exclusion Criteria:
self-identify as a woman
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Mazor | Contact | (510) 418-8642 | melissa.mazor@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Mazor | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism Following publication and any de-identified data and supportive documents can be requested from melissa.mazor@mountsinai.org
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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. |
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Fidelity: This is indicated if >80% of the visits are conducted according to the ACCESS manual.
| 9 months |
| Change in The Impact of Event Scale - Revised (IES-R) scores | 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. | Baseline and 9 months |
| Change in The Memorial Symptom Assessment Scale (MSAS) | 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. | Baseline and 9 months |
| D017437 |
| Skin and Connective Tissue Diseases |