Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

Not Applicable

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Other: Shared Medical Decision Tool; Behavioral: Engaging Patients in Decision Making; Behavioral: Literacy Spanish Language

• Registration Number: NCT06036810
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-08-31
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Study Phase 1	Shared Medical Decision Tool	Pre-testing and cognitive interviews for the Decision Support Tool
Study Phase 1	Engaging Patients in Decision Making	Pre-testing and cognitive interviews for the Decision Support Tool
Study Phase 2	Shared Medical Decision Tool	Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
Study Phase 1	Literacy Spanish Language	Pre-testing and cognitive interviews for the Decision Support Tool
Study Phase 2	Engaging Patients in Decision Making	Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
Study Phase 2	Literacy Spanish Language	Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).

Primary Outcome Measures

Name	Time	Method
Decision Regret Scale questionnaire	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").

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States