Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Other: Shared Medical Decision Tool; Behavioral: Engaging Patients in Decision Making; Behavioral: Literacy Spanish Language

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06036810

NCI-2023-07034 (Other Identifier)

2022-0539

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Study Phase 1

Experimental group

Description:

Pre-testing and cognitive interviews for the Decision Support Tool

Treatment:

Behavioral: Literacy Spanish Language

Behavioral: Engaging Patients in Decision Making

Other: Shared Medical Decision Tool

Study Phase 2

Experimental group

Description:

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

Treatment:

Behavioral: Literacy Spanish Language

Behavioral: Engaging Patients in Decision Making

Other: Shared Medical Decision Tool