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Trial Title:
Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
NCT ID:
NCT06543537
Condition:
Ovarian Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Ovarian Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Collaborative Agenda-Setting Intervention
Description:
A collaborative agenda-setting intervention (CASI) to promote patient-centered
communication, set agendas for discussion at in-clinic visits, increase discussion of
psychosocial concerns, and reduce clinician burden. The intervention is integrated into
the patient portal and electronic health record. Prior to a clinic visit, the
intervention elicits patients' and caregivers' preferences and concerns, then
communicates this information to clinicians. Patients, caregivers, and clinicians receive
communication resources, while patients and caregivers receive tailored educational
materials and navigation to supportive care services.
Arm group label:
Arm 1: CASI Intervention
Other name:
CASI
Summary:
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)
Detailed 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.
Criteria for eligibility:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Rachel Pozzar, PhD
Phone:
857-215-0743
Email:
Rachel_Pozzar@dfci.harvard.edu
Investigator:
Last name:
Rachel Pozzar, PhD
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Rachel Pozzar, PhD
Phone:
857-215-0743
Email:
Rachel_Pozzar@dfci.harvard.edu
Investigator:
Last name:
Rachel Pozzar, PhD
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Institute of Nursing Research (NINR)
Agency class:
NIH
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06543537
