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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Engaging Patients in Decision Making, Literacy Spanish Language, Shared Medical Decision Tool, Lynparza for ovarian cancer?

Research shows that shared decision-making tools, especially those tailored to language and literacy needs, can improve patient understanding and involvement in their treatment choices, which is crucial for effective cancer care. Additionally, studies indicate that decision aids can help patients feel more prepared and satisfied with their treatment decisions, which may enhance their overall treatment experience. ^{1 2 3 4 5}

How does the Decision-Making Tool for Ovarian Cancer differ from other treatments?

The Decision-Making Tool for Ovarian Cancer is unique because it is an evidence-based online decision aid designed to improve shared decision-making between patients with advanced ovarian cancer and their medical team, rather than a traditional medical treatment. ^{1 3 6 7 8}

Research Team

Larissa A. Meyer

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

I can understand, speak, or read Spanish.

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 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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Women's perceptions about treatment decision making for ovarian cancer. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

The relationship between health literacy and perceived shared decision making in patients with breast cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Shared Decision Making in Latino Men With Prostate Cancer: A Thematic Analysis. [2022]

4. United States 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. [2022]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Development of a decision aid for primary treatment of patients with advanced-stage ovarian cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Development and pilot of an advance care planning website for women with ovarian cancer: a randomized controlled trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Developing and Pilot Testing a Spanish Translation of CollaboRATE for Use in the United States. [2018]