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

Dana-Farber Cancer Institute

Status: Not yet enrolling

Conditions: Ovarian Neoplasms; Ovarian Carcinoma; Ovarian Cancer

Treatments: Behavioral: Collaborative Agenda-Setting Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06543537

K23NR020219 (U.S. NIH Grant/Contract)

24-358

Details and patient eligibility

About

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)

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 2 patient groups

Arm 1: CASI Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Collaborative Agenda-Setting Intervention

Arm 2: Control

No Intervention group

Description:

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