Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

NCT06036810 | Recruiting DMC

• 2 other identifiers: 2022-0539NCI-2023-07034
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 2 year.

Study Arms (2)

Study Phase 1

EXPERIMENTAL

Pre-testing and cognitive interviews for the Decision Support Tool

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

Study Phase 2

EXPERIMENTAL

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

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

Interventions

Shared Medical Decision Tool OTHER

standard of care

Study Phase 1; Study Phase 2

Engaging Patients in Decision Making BEHAVIORAL

standard of care

Study Phase 1; Study Phase 2

Literacy Spanish Language BEHAVIORAL

standard of care

Study Phase 1; Study Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability or unwillingness to sign informed consent
• 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).
• Inability or unwillingness to sign informed consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Larissa Meyer, Meyer

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larissa Meyer, M D

CONTACT

(713) 745-0973; Lmeyer@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)