Collaborative Agenda-Setting for Ovarian Cancer

Recruiting at1 trial location

Overseen by Rachel Pozzar, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Age under 18, unable to consent

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians. The name of the intervention in this research study is: -Collaborative Agenda-Setting Intervention (CASI)

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 is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Collaborative Agenda-Setting Intervention for ovarian cancer?

The study 'Bridging the Gap: A Priorities Assessment Tool to Support Shared Decision Making' highlights the importance of patient-physician communication in treatment decisions for women with ovarian cancer, suggesting that tools enhancing communication and shared decision-making can increase patient satisfaction, which is a key component of the Collaborative Agenda-Setting Intervention. ^{1 2 3 4 5}

How is the Collaborative Agenda-Setting Intervention treatment for ovarian cancer different from other treatments?

The Collaborative Agenda-Setting Intervention is unique because it focuses on improving patient engagement and decision-making by involving patients in setting their treatment goals and priorities, which is different from traditional treatments that may not emphasize patient collaboration in the decision-making process. ^{3 4 5 6 7}

Research Team

Rachel Pozzar, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for English-speaking adults with advanced ovarian cancer (stage III, IV, or recurrent) who are scheduled for chemotherapy. It includes caregivers and clinicians involved in their care. Participants must be willing to use a communication tool and be audio recorded. Caregivers should discuss the patient's care with them and clinicians should see at least 4 such patients monthly.

Inclusion Criteria

Caregiver: Able to speak, understand, and respond to questions written in English

Participant: Be signed up or willing to sign up for Patient Gateway

I am a caregiver and I am at least 18 years old.

Exclusion Criteria

I am unable to give consent by myself.

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Collaborative Agenda-Setting Intervention (CASI) or usual oncology care over three visits

12 weeks

3 visits (in-person), additional virtual interactions for CASI group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up for clinicians

Clinicians continue to be monitored for up to 52 weeks

52 weeks

Treatment Details

Interventions

• Collaborative Agenda-Setting Intervention (Behavioral Intervention)

Trial Overview The study tests a new communication method called Collaborative Agenda-Setting Intervention (CASI). It aims to improve discussions between patients with ovarian cancer, their caregivers, and healthcare providers during treatment planning.

Participant Groups

Group I: Arm 1: CASI Intervention Experimental Treatment 1 Intervention

Enrolled patients and caregivers will complete: * Audio recorded baseline visit * CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 1 * Audio recorded CASI visit 1 * CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 2 * Audio recorded CASI visit 2 * CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 3 * Audio recorded CASI visit 3 * End of study visit For each enrolled patient, enrolled clinicians will complete: * Audio recorded baseline visit * Audio recorded CASI visit 1 * Audio recorded CASI visit 2 * Audio recorded CASI visit 3 Enrolled clinicians will also complete: * Baseline visit, one time * End of study visit, one time

Group II: Arm 2: Control Active Control 1 Intervention

Enrolled patients and caregivers will complete: * Audio recorded baseline visit * Audio recorded visit 1 will proceed according to usual, oncology care * Audio recorded visit 2 will proceed according to usual, oncology care * Audio recorded visit 3 will proceed according to usual, oncology care * End of study visit For each enrolled patient, enrolled clinicians will complete: * Audio recorded baseline visit * Audio recorded visit 1 will proceed according to usual, oncology care * Audio recorded visit 2 will proceed according to usual, oncology care * Audio recorded visit 3 will proceed according to usual, oncology care Enrolled clinicians will also complete: * Baseline visit, one time * End of study visit, one time

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Findings from Research

A study of 7987 patients with advanced epithelial ovarian cancer (EOC) showed that centralization of care and changes in treatment sequence significantly improved surgical outcomes, with optimal cytoreduction rates increasing from 55% in 2004 to 87% in 2013.

Overall survival rates also improved, with a 3% annual reduction in the risk of death observed from 2004 to 2013, indicating that the new treatment approaches are effective in enhancing patient survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved outcomes due to changes in organization of care for patients with ovarian cancer in the Netherlands. Eggink, FA., Mom, CH., Kruitwagen, RF., et al.[2017]

A patient-centered priorities assessment tool was developed for women with ovarian cancer, combining symptom assessment and quality-of-life priorities, and was found to be easy to understand and comprehensive by participants.

In a pilot study with 36 women, the tool helped 69.4% of participants identify changing goals since diagnosis, enhancing their comfort in shared decision-making with healthcare providers, which could lead to improved patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap: A Priorities Assessment Tool to Support Shared Decision Making, Maximize Appointment Time, and Increase Patient Satisfaction in Women With Ovarian Cancer. Frey, MK., Ellis, A., Shyne, S., et al.[2021]

This study identified key components necessary for high-quality care delivery in ovarian cancer treatment, emphasizing the importance of care coordination, patient education, and addressing unmet medical needs.

A multidisciplinary expert committee developed comprehensive recommendations to improve ovarian cancer care, highlighting the need for collaboration among healthcare providers to overcome implementation challenges and enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations. Temkin, SM., Smeltzer, MP., Dawkins, MD., et al.[2022]

A systematic review of 33 high-quality studies identified several factors influencing whether women with ovarian cancer receive guideline care, including race, socioeconomic status, insurance type, and geographic location.

The decision-making process for treatment among women with ovarian cancer is influenced by personal factors such as the desire to prolong survival, the patient-provider relationship, and individual values, highlighting the need for more patient-centered research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered research priorities in ovarian cancer: A systematic review of potential determinants of guideline care. Pozzar, RA., Berry, DL.[2022]

In a study of 41 multidisciplinary team (MDT) meetings focused on advanced ovarian cancer, decision-making was primarily influenced by clinical presentation, patient factors, chair's direction, and input from other specialties, highlighting the importance of comprehensive case information.

Patient factors were often underrepresented in discussions, suggesting a need to empower nurses to contribute more actively, as their involvement can enhance the consideration of patient perspectives in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision-Making in Gynaecological Oncology Multidisciplinary Team Meetings: A Cross-Sectional, Observational Study of Ovarian Cancer Cases. Scott, R., Hawarden, A., Russell, B., et al.[2020]

Treatment by gynecologic oncologists (GOs) significantly improves overall survival rates for women with ovarian cancer, highlighting the importance of specialized care.

The review identified five strategic categories to promote GO treatment, including increasing awareness of GOs' roles, improving care models and payment structures, and expanding the GO workforce, although evidence of their effectiveness in the U.S. is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Strategies to Increase Gynecologic Oncologist Treatment for Ovarian Cancer. Stewart, SL., Mezzo, JL., Nielsen, D., et al.[2023]

A pilot study involving six nurses showed that a structured training program for nurse-led decision coaching is feasible and can effectively prepare nurses to support BRCA1/2 mutation carriers in making informed preventive health decisions.

The training program was adapted to a virtual format due to the COVID-19 pandemic, indicating flexibility in delivery methods, and highlights the need for further research to assess the effectiveness and acceptability of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study. Berger-Höger, B., Vitinius, F., Fischer, H., et al.[2022]

References

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

Improved outcomes due to changes in organization of care for patients with ovarian cancer in the Netherlands. [2017]

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

Bridging the Gap: A Priorities Assessment Tool to Support Shared Decision Making, Maximize Appointment Time, and Increase Patient Satisfaction in Women With Ovarian Cancer. [2021]

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

Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations. [2022]

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

Patient-centered research priorities in ovarian cancer: A systematic review of potential determinants of guideline care. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Decision-Making in Gynaecological Oncology Multidisciplinary Team Meetings: A Cross-Sectional, Observational Study of Ovarian Cancer Cases. [2020]

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

Potential Strategies to Increase Gynecologic Oncologist Treatment for Ovarian Cancer. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study. [2022]