Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036810
• Other study ID #: 2022-0539
• Secondary ID: NCI-2023-07034
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: Larissa Meyer, M D
• Phone: (713) 745-0973
• Email: Lmeyer[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Shared Medical Decision Tool
standard of care

Behavioral:
• Engaging Patients in Decision Making
standard of care
• Literacy Spanish Language
standard of care

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   M D Anderson Cancer Center