Understanding the Burden of ACC Through the Eyes of Patients
Study Details
Study Description
Brief Summary
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.
Primary Objectives:
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To identify the specific burdens faced by patients with ACC
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To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.
Primary Objectives:
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To identify the specific burdens faced by patients with ACC
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To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)
Secondary Objectives:
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To assess QoL implication in patients living with ACC (Adenoid Cystic Carcinoma)
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To compare the burdens and QoL impacts in people living with ACC, with their tumors bearing Notch mutations or Notch Wild Type due to:
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Rate of disease progression
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Location of Metastases
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 No evident disease |
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| 2 Metastatic Disease; Watchful Waiting: Tumors bearing NOTCH Mutation |
|
| 3 Metastatic Disease; Watchful Waiting: Tumors bearing Notch Wild Type |
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| 4 Progressive Disease: Tumors bearing NOTCH Mutation |
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| 5 Progressive Disease: Tumors bearing Notch Wild Type |
Outcome Measures
Primary Outcome Measures
- Key burdens related to the disease or treatments [Q4-2021]
- Life impacts of those burdens for patient/family [Q4-2021]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant must be a person diagnosed with ACC who is 18 years or older
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For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor
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Histologically-confirmed diagnosis of ACC with written proof of disease and molecular profile of tumor provided. This can be a note showing genetic diagnosis from a relevant testing laboratory, physician consult notes, a medical record of diagnosis, or any other single piece of documentation that connects your name/the patient's name with ACC.
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Able to read, write and understand English, Hebrew, Arabic, or Russian
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Able to grant informed consent
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Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary)
Exclusion Criteria:
- Inability to meet any of the inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Engage Health | Eagan | Minnesota | United States | 55121 |
Sponsors and Collaborators
- Ayala Pharmaceuticals, Inc,
- Adenoid Cystic Carcinoma Research Foundation (ACCRF)
- Memorial Sloan Kettering Cancer Center
- Hadassah Medical Organization
- Engage Health Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AL Patient Burden 01