Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06036810

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shared Medical Decision Tool

Engaging Patients in Decision Making

Literacy Spanish Language

Study Details

Brief summary:

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

Conditions

Ovarian Cancer

Study ID

NCT06036810

Start date

Aug 31, 2023

Status verified date

Apr, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Study Phase 1

Pre-testing and cognitive interviews for the Decision Support Tool

experimental: Study Phase 2

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

Interventions

Shared Medical Decision Tool

standard of care

Engaging Patients in Decision Making

standard of care

Literacy Spanish Language

standard of care

Primary outcome measure

  • Decision Regret Scale questionnaire [ Time Frame: through study completion; an average of 2 year. ]

Central Contacts and Locations

Central contacts

Larissa Meyer, M D

(713) 745-0973Lmeyer@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Larissa Meyer, M D

713-745-0973lmeyer@mdanderson.org

Principal Investigator:

Larissa Meyer, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.