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Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer

Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer

Recruiting
18 years and older
Female
Phase N/A

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Overview

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)

Description

This two-arm, parallel group-randomized research study is to test a new communication tool (CASI) for people with ovarian cancer, caregivers, and clinicians. This is a pilot feasibility study, which means this is the first time researchers are studying CASI. Clinicians will be randomized into one of the two study groups, Arm 1 or Arm 2, and patients and caregivers will be enrolled in the study arm to which their clinician has been randomized.

The research study procedures include screening for eligibility, audio recorded clinic visits, and questionnaires.

Participation in this research study is expected to last for up to 12 weeks for patients and caregivers, and for up to 52 weeks for clinicians.

It is expected that up to 112 people will take part in this research study, including up to 50 patients, 50 caregivers, and 12 clinicians (six dyads).

The National Institute for Nursing Research is supporting this research by providing funding.

Eligibility

Participant Inclusion Criteria:

  • At least 18 years old
  • Able to speak, understand, and respond to questions written in English
  • Willing to be audio recorded
  • Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)
  • Be under the care of a participating clinician dyad
  • Be scheduled for chemotherapy during the recruitment period
  • Be signed up or willing to sign up for Patient Gateway

Caregiver Inclusion Criteria:

  • At least 18 years old
  • Able to speak, understand, and respond to questions written in English
  • Willing to be audio recorded
  • Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care

Clinician Inclusion Criteria:

  • Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant
  • Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting

Participant Exclusion Criteria:

  • Age of <18 years
  • Unable to consent

Study details
    Ovarian Cancer
    Ovarian Neoplasms
    Ovarian Carcinoma

NCT06543537

Dana-Farber Cancer Institute

28 August 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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