Back to resultsSpanish Decision Tool for Ovarian Cancer Maintenance Therapy
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Medical Decision Tool
Engaging Patients in Decision Making
Literacy Spanish Language
Sponsored by
About this trial
This is an interventional health services research trial for Ovarian Cancer
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study Phase 1
Study Phase 2
Arm Description
Pre-testing and cognitive interviews for the Decision Support Tool
Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
Full Information
NCT ID
NCT06036810
First Posted
September 7, 2023
Last Updated
September 26, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT06036810
Brief Title
Spanish Decision Tool for Ovarian Cancer Maintenance Therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Phase 1
Arm Type
Experimental
Arm Description
Pre-testing and cognitive interviews for the Decision Support Tool
Arm Title
Study Phase 2
Arm Type
Experimental
Arm Description
Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
Intervention Type
Other
Intervention Name(s)
Shared Medical Decision Tool
Intervention Description
standard of care
Intervention Type
Behavioral
Intervention Name(s)
Engaging Patients in Decision Making
Intervention Description
standard of care
Intervention Type
Behavioral
Intervention Name(s)
Literacy Spanish Language
Intervention Description
standard of care
Primary Outcome Measure Information:
Title
Decision Regret Scale questionnaire
Description
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").
Time Frame
through study completion; an average of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa Meyer, M D
Phone
(713) 745-0973
Email
Lmeyer@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa Meyer, Meyer
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larissa Meyer, M D
Phone
713-745-0973
Email
lmeyer@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Larissa Meyer, MD
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Spanish Decision Tool for Ovarian Cancer Maintenance Therapy
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