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Behavioral Intervention

Collaborative Agenda-Setting for Ovarian Cancer

N/A

Waitlist Available

Led By Rachel Pozzar, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant: At least 18 years old

Participant: Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)

Must not have

Participant: Age of <18 years

Participant: Unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new communication tool called Collaborative Agenda-Setting Intervention (CASI) for people with ovarian cancer, caregivers, and clinicians.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since CASI is a communication tool rather than a medical treatment, it does not have physical side effects like drugs do. However, participants may experience emotional or psychological impacts from discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My condition is advanced ovarian cancer (stage III, IV, or recurrent).

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I am scheduled for chemotherapy during the recruitment period.

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I treat at least 4 patients monthly with advanced ovarian cancer in an outpatient setting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment Rate

Secondary study objectives

Acceptability of Intervention

Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)

Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 6Eligibility criteria met