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Recruiting

NCT Number: NCT06036810

Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Larissa Meyer, M D

CONTACT

[email protected]

713-745-0973

Larissa Meyer, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared Medical Decision Tool

Other

standard of care

Engaging Patients in Decision Making

Behavioral

standard of care

Literacy Spanish Language

Behavioral

standard of care

Primary outcomes

  1. Decision Regret Scale questionnaire

    Time frame: through study completion; an average of 2 year.

    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").

Study contacts

Contact information is provided by the study sponsor or research team.

Larissa Meyer, M D

CONTACT

[email protected]

(713) 745-0973

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2023
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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