Clinical trial NCT06543537: Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
Official title: Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Keywords: Ovarian Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-08-09
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: Enrollment Rate
timeFrame: Pre-consent
Secondary outcomes:
measure: Acceptability of Intervention
timeFrame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
measure: Proportion of Participant-Rated Intervention Helpfulness
timeFrame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
measure: Proportion of Participant-Rated Intervention Burden
timeFrame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
measure: Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1)
timeFrame: Baseline and 12 weeks after enrollment
measure: Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)
timeFrame: Baseline and 12 weeks after enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rachel Pozzar, PhD
role: PRINCIPAL_INVESTIGATOR
References: