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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-07034 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Phase 1 | Experimental | Pre-testing and cognitive interviews for the Decision Support Tool |
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| Study Phase 2 | Experimental | Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Medical Decision Tool | Other | standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Decision Regret Scale questionnaire | This scale measures decisional regret related to health care decisions at a specific point in time. This tool consists of 5 questions answered on a Likert scale (1="Strongly agree" to 5="Strongly disagree"). | through study completion; an average of 2 year. |
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Study population: This study will enroll patients and clinical providers.
Inclusion criteria: Patients
• Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or have completed platinum-based chemotherapy for ovarian cancer and are potentially eligible to receive maintenance therapy; 2) able to understand, speak or read in Spanish.
Exclusion criteria: Patients
• Inability or unwillingness to sign informed consent
Inclusion criteria: Clinicians
• Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced practice providers who practice at the Houston Area Locations (HALs), MD Anderson Cancer Center, or our county safety net hospital, The Harris Health System (LBJ Hospital).
Exclusion criteria: Clinicians
• Inability or unwillingness to sign informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larissa Meyer, M D | Contact | (713) 745-0973 | Lmeyer@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Larissa Meyer, Meyer | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Engaging Patients in Decision Making |
| Behavioral |
standard of care |
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| Literacy Spanish Language | Behavioral | standard of care |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |