112 Participants Needed

Collaborative Agenda-Setting for Ovarian Cancer

Recruiting at 1 trial location
RP
Overseen ByRachel Pozzar, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.34567

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)

Research Team

RP

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
Clinician: Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant
See 8 more

Exclusion Criteria

I am unable to give consent by myself.
I am under 18 years old.

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
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: CASI InterventionExperimental Treatment1 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: ControlActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

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.
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.
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.
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]

References

Improved outcomes due to changes in organization of care for patients with ovarian cancer in the Netherlands. [2017]
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]
Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations. [2022]
Patient-centered research priorities in ovarian cancer: A systematic review of potential determinants of guideline care. [2022]
Decision-Making in Gynaecological Oncology Multidisciplinary Team Meetings: A Cross-Sectional, Observational Study of Ovarian Cancer Cases. [2020]
Potential Strategies to Increase Gynecologic Oncologist Treatment for Ovarian Cancer. [2023]
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]
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