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Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Ovarian Cancer

Treatments

Behavioral: Engaging Patients in Decision Making
Other: Shared Medical Decision Tool
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)

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
Other: Shared Medical Decision Tool
Behavioral: Engaging Patients in Decision Making
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
Other: Shared Medical Decision Tool
Behavioral: Engaging Patients in Decision Making

Trial contacts and locations

1

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Central trial contact

Larissa Meyer, M D

Data sourced from clinicaltrials.gov

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