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Spanish Decision Tool for Ovarian Cancer Maintenance Therapy

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06036810
Enrollment
70
Registered
2023-09-14
Start date
2023-08-31
Completion date
2027-10-31
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

OTHERShared Medical Decision Tool

standard of care

BEHAVIORALEngaging Patients in Decision Making

standard of care

BEHAVIORALLiteracy Spanish Language

standard of care

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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).

Design outcomes

Primary

MeasureTime frameDescription
Decision Regret Scale questionnairethrough 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").

Countries

United States

Contacts

CONTACTLarissa Meyer, M D
Lmeyer@mdanderson.org(713) 745-0973
PRINCIPAL_INVESTIGATORLarissa Meyer, Meyer

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026