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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06036810

Collaborator

Merk (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Other: Shared Medical Decision Tool Behavioral: Engaging Patients in Decision Making Behavioral: Literacy Spanish Language	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase1 Patients for the initial testing of the SDM tool	Other: Shared Medical Decision Tool standard of care Behavioral: Engaging Patients in Decision Making standard of care Behavioral: Literacy Spanish Language standard of care
Experimental: Phase2A Patients with Usual Care- Control	Other: Shared Medical Decision Tool standard of care Behavioral: Engaging Patients in Decision Making standard of care Behavioral: Literacy Spanish Language standard of care
Experimental: Phase2B Patients with Shared medical decision tool- Intervention	Other: Shared Medical Decision Tool standard of care Behavioral: Engaging Patients in Decision Making standard of care Behavioral: Literacy Spanish Language standard of care

Arm

Intervention/Treatment

Experimental: Phase1

Patients for the initial testing of the SDM tool

Other: Shared Medical Decision Tool

standard of care

Behavioral: Engaging Patients in Decision Making

standard of care

Behavioral: Literacy Spanish Language

standard of care

Experimental: Phase2A

Patients with Usual Care- Control

Other: Shared Medical Decision Tool

standard of care

Behavioral: Engaging Patients in Decision Making

standard of care

Behavioral: Literacy Spanish Language

standard of care

Experimental: Phase2B

Patients with Shared medical decision tool- Intervention

Other: Shared Medical Decision Tool

standard of care

Behavioral: Engaging Patients in Decision Making

standard of care

Behavioral: Literacy Spanish Language

standard of care

Outcome Measures

Primary Outcome Measures

Decision Regret Scale questionnaire [through study completion; an average of 1 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").

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Study population: This study will enroll patients and clinical providers.

Inclusion criteria:

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.
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:

Inability or unwillingness to sign informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center
Merk

Investigators

Principal Investigator: Larissa Meyer, Meyer, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

M D Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT06036810

Other Study ID Numbers:

2022-0539
NCI-2023-07034

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Sep 14, 2023