Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

Study Overview
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Brief Summary
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To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy

Detailed Description
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Objectives: Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer maintenance therapy for Spanish speaking individuals. To explore the feasibility and acceptability of incorporating the SDM tool into routine clinical care for Spanish speaking individuals. To estimate the effectiveness of the SDM tool on quality of the decision making in patients with ovarian cancer who are making decisions about maintenance therapy through a pilot study.

Official Title
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Engaging Patients in Decision Making: The Development and Pilot Testing of a Low Literacy Spanish Language Shared Medical Decision Tool for Ovarian Cancer Maintenance Therapy

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Other: Shared Medical Decision Tool
* Behavioral: Engaging Patients in Decision Making
* Behavioral: Literacy Spanish Language


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Phase 1<br>Pre-testing and cognitive interviews for the Decision Support Tool | Other: Shared Medical Decision Tool<br>* standard of care<br>Behavioral: Engaging Patients in Decision Making<br>* standard of care<br>Behavioral: Literacy Spanish Language<br>* standard of care<br>|
| Experimental: Study Phase 2<br>Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group). | Other: Shared Medical Decision Tool<br>* standard of care<br>Behavioral: Engaging Patients in Decision Making<br>* standard of care<br>Behavioral: Literacy Spanish Language<br>* standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 1 year. |