Decision-Making Tool for Ovarian Cancer

Overseen By Larissa Meyer, M D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Inability to sign consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create a tool to help Spanish-speaking patients make informed decisions about their maintenance therapy for ovarian cancer. The trial consists of two parts: one group will receive usual care, while the other will use the new decision-making tool, the Shared Medical Decision Tool, with assistance from their healthcare provider. It suits those with advanced ovarian, fallopian tube, or peritoneal cancer who have undergone specific chemotherapy and understand Spanish. As an unphased trial, it provides a unique opportunity to contribute to developing a tool that could enhance decision-making for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision-making tool is safe for patients?

Research shows that shared decision-making tools, like the one being tested for ovarian cancer, are generally safe. These tools assist patients in making informed treatment choices. Studies indicate that patients value these tools, which pose no safety risks.

For instance, research demonstrates that decision aids have effectively helped patients understand genetic testing and treatment options without causing harm. Used alongside medical advice, these aids ensure patients feel supported and informed.

In this trial, the decision-making tool, not a drug or medical procedure, is being tested, so there are no known physical side effects. The tool aims to enhance communication between patients and healthcare providers, a safe and beneficial goal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance decision-making for ovarian cancer treatment. Unlike conventional methods that often leave patients feeling overwhelmed, this trial explores a new decision support tool that actively engages patients and incorporates language accessibility, especially for Spanish speakers. By focusing on shared medical decision-making, this approach empowers patients with personalized guidance, making it stand out from standard care options that may not fully address individual patient needs or preferences.

What evidence suggests that this decision-making tool is effective for ovarian cancer?

Research has shown that tools for shared decision-making can help patients with ovarian cancer make informed choices about their care. In this trial, participants will either receive usual care or use a Decision Support Tool with provider guidance. For example, one study tested a decision aid that helped patients compare different chemotherapy options. Such tools empower patients to better understand their treatment choices, potentially leading to better outcomes. By improving communication between patients and doctors, these tools help patients make decisions that align with their values and preferences. Although not a treatment itself, the tool can significantly enhance the quality of care patients receive. ^{1 6 7 8 9}

Who Is on the Research Team?

Larissa A. Meyer

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking individuals over 18 with advanced ovarian, fallopian tube, or primary peritoneal cancer who have had or are undergoing platinum-based chemotherapy and may receive maintenance therapy. Participants must understand Spanish. Eligible clinicians include MD Anderson gynecologic oncologists and providers at specific Houston locations.

Inclusion Criteria

Clinicians must be 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)

I can understand, speak, or read Spanish.

I am 18 or older with advanced ovarian, fallopian tube, or peritoneal cancer and have completed or am receiving platinum-based chemotherapy.

Exclusion Criteria

Patients must have inability or unwillingness to sign informed consent

Clinicians must have inability or unwillingness to sign informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-testing and cognitive interviews

Pre-testing and cognitive interviews for the Decision Support Tool

4-8 weeks

Intervention

Participants utilize the Decision Support Tool with Provider guidance

Variable, up to 2 years

Follow-up

Participants are monitored for decision-making quality and decisional regret

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Engaging Patients in Decision Making
• Literacy Spanish Language
• Shared Medical Decision Tool

Trial Overview

The study aims to develop a tool that helps Spanish-speaking patients engage in shared decision-making regarding their maintenance therapy after initial treatment for ovarian cancer. It focuses on improving patient literacy and involvement in medical decisions.

How Is the Trial Designed?

Group I: Study Phase 2 Experimental Treatment 3 Interventions

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

Group II: Study Phase 1 Experimental Treatment 3 Interventions

Pre-testing and cognitive interviews for the Decision Support Tool

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

A web-based tool was developed to assist women with ovarian cancer in advance care planning, focusing on advance healthcare directives and palliative care, and was tested in a pilot study with 53 participants.

While the tool did not significantly increase the completion rates of advance healthcare directives or palliative care consultations, it did help reduce decisional conflict and improve user satisfaction with the information provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot of an advance care planning website for women with ovarian cancer: a randomized controlled trial. Vogel, RI., Petzel, SV., Cragg, J., et al.[2021]

A new online decision aid was developed for patients with advanced epithelial ovarian cancer, based on input from both patients and clinicians, to improve shared decision-making regarding treatment options.

The decision aid addresses a significant need for reliable information, as 90% of patients reported not being offered a choice of treatment, and it includes personalized summaries to facilitate discussions with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a decision aid for primary treatment of patients with advanced-stage ovarian cancer. den Ouden, JE., The, R., Myren, BJ., et al.[2021]

The study successfully developed a Spanish version of the CollaboRATE measure for shared decision-making, ensuring it was understandable to Spanish-speaking patients through extensive cognitive interviews with 26 participants.

In a pilot test with 1,230 patients, both the English and Spanish versions of CollaboRATE showed the same high level of satisfaction, with 86% of respondents giving the best score possible, indicating the effectiveness of the translation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Pilot Testing a Spanish Translation of CollaboRATE for Use in the United States. Forcino, RC., Bustamante, N., Thompson, R., et al.[2018]

In a study of 511 breast cancer patients, higher health literacy in healthcare and disease prevention was linked to a greater perception of shared decision making (SDM) during consultations, while lower health literacy in health promotion was associated with lower perceived SDM.

The relationship between health literacy and perceived SDM varied by age and education level, suggesting that clinicians should tailor their communication strategies based on a patient's health literacy to enhance shared decision making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between health literacy and perceived shared decision making in patients with breast cancer. Shen, HN., Lin, CC., Hoffmann, T., et al.[2019]

Spanish-speaking breast cancer patients demonstrated lower health literacy and health numeracy compared to English-speaking patients, which may impact their understanding of radiation therapy.

Despite no significant difference in overall radiation knowledge scores between language groups, lower education and health literacy were linked to poorer identification of long-term side effects of radiotherapy, highlighting the need for improved communication strategies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and Understanding of Radiation Therapy Among Patients With Breast Cancer From Culturally Diverse Backgrounds at a Safety-Net Hospital. Vassantachart, A., Ragab, O., Miller, K., et al.[2023]

Women with advanced epithelial ovarian cancer understood the risks and benefits of their treatment options but often felt overwhelmed and pressured in the decision-making process due to their illness and treatment effects.

The treatment decision-making process was largely physician-directed, with women feeling they had limited choices, highlighting the need for physicians to create an environment that encourages shared decision-making when patients desire it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's perceptions about treatment decision making for ovarian cancer. Elit, L., Charles, C., Gold, I., et al.[2022]

A study involving 20 Latino men with newly diagnosed prostate cancer revealed that language preference significantly influences health information-seeking behaviors and preferences for decision aids, with English speakers favoring self-guided digital tools and Spanish speakers preferring family-involved, paper-based aids.

English-speaking participants demonstrated higher digital technology proficiency and education levels, suggesting that tailored approaches are necessary to effectively prepare both English and Spanish speakers for shared decision-making in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Shared Decision Making in Latino Men With Prostate Cancer: A Thematic Analysis. Michel, J., Ballon, J., Connor, SE., et al.[2022]

Among Latinas with breast cancer, only 63% reported congruency between their preferred and actual involvement in medical decision-making, compared to 76% of non-Latina White women, highlighting a potential gap in communication and decision-making satisfaction.

Greater use of English among Latinas was associated with improved communication effectiveness, which in turn was linked to higher treatment satisfaction and better quality of life outcomes, suggesting that enhancing language skills could be beneficial in medical contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer treatment decision making among Latinas and non-Latina Whites: a communication model predicting decisional outcomes and quality of life. Yanez, B., Stanton, AL., Maly, RC.[2022]

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