Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

NCT ID: NCT06036810

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2027-10-31

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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Study Phase 1

Pre-testing and cognitive interviews for the Decision Support Tool

Group Type EXPERIMENTAL

Shared Medical Decision Tool

Intervention Type OTHER

standard of care

Engaging Patients in Decision Making

Intervention Type BEHAVIORAL

standard of care

Literacy Spanish Language

Intervention Type BEHAVIORAL

standard of care

Study Phase 2

Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).

Group Type EXPERIMENTAL

Shared Medical Decision Tool

Intervention Type OTHER

standard of care

Engaging Patients in Decision Making

Intervention Type BEHAVIORAL

standard of care

Literacy Spanish Language

Intervention Type BEHAVIORAL

standard of care

Interventions

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Shared Medical Decision Tool

standard of care

Intervention Type OTHER

Engaging Patients in Decision Making

standard of care

Intervention Type BEHAVIORAL

Literacy Spanish Language

standard of care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

• 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.


• 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

• Inability or unwillingness to sign informed consent


• Inability or unwillingness to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larissa Meyer, Meyer

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Larissa Meyer, M D

Role: CONTACT

(713) 745-0973

Facility Contacts

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Larissa Meyer, M D

Role: primary

713-745-0973

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2023-07034

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0539

Identifier Type: -

Identifier Source: org_study_id

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