Ovarian CancerNCT06036810
Spanish Decision Tool for Ovarian Cancer Maintenance Therapy
A study testing Shared Medical Decision Tool, Engaging Patients in Decision Making and Literacy Spanish Language in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Shared Medical Decision Tool, Engaging Patients in Decision Making and Literacy Spanish Language
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Inability or unwillingness to sign informed consent
- Inability or unwillingness to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Larissa Meyer, M D, 713-745-0973, lmeyer@mdanderson.org
Larissa Meyer, MD
About this study
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
To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Shared Medical Decision Tool, Engaging Patients in Decision Making, Literacy Spanish Language
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Medical Decision ToolOther
standard of care
Engaging Patients in Decision MakingBehavioural
standard of care
Literacy Spanish LanguageBehavioural
standard of care
| Study group | Role | What they receive |
|---|---|---|
| Study Phase 1 | Experimental | Pre-testing and cognitive interviews for the Decision Support Tool Receives: 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). Receives: Other: Shared Medical Decision Tool; Behavioral: Engaging Patients in Decision Making; Behavioral: Literacy Spanish Language |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: through study completion; an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start31 Aug 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Larissa Meyer, Meyer, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036810
- Sponsor's protocol ID
- 2022-0539
- Other IDs
- NCI-2023-07034
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06036810
- Acronym / sponsor ID
- 2022-0539
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Phase 1 | Experimental | Other: Shared Medical Decision Tool, Behavioral: Engaging Patients in Decision Making, Behavioral: Literacy Spanish LanguagePre-testing and cognitive interviews for the Decision Support Tool |
| Study Phase 2 | Experimental | Other: Shared Medical Decision Tool, Behavioral: Engaging Patients in Decision Making, Behavioral: Literacy Spanish LanguageUsual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Inability or unwillingness to sign informed consent
- Inability or unwillingness to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Medical Decision Toolstandard of care | Other | Study Phase 1, Study Phase 2 |
| Engaging Patients in Decision Makingstandard of care | Behavioural | Study Phase 1, Study Phase 2 |
| Literacy Spanish Languagestandard of care | Behavioural | Study Phase 1, Study Phase 2 |
Primary outcome
Decision Regret Scale questionnaire
Time frame: 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").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Larissa Meyer, Meyer principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Decision Tool, Engaging Patients in Decision Making and Literacy Spanish Language in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larissa Meyer, M D ((713) 745-0973, Lmeyer@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Regret Scale questionnaire (time frame: through study completion; an average of 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.