Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collaborative Agenda-Setting Intervention.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
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.
Interventions
- Behavioral Collaborative Agenda-Setting Intervention
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 c
Primary outcome measures
- Enrollment Rate [Time frame: Pre-consent]
Secondary outcome measures (5)
- Acceptability of Intervention [Time frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment]
- Proportion of Participant-Rated Intervention Helpfulness [Time frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment]
- Proportion of Participant-Rated Intervention Burden [Time frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment]
- Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1) [Time frame: Baseline and 12 weeks after enrollment]
- Change in FACT-G Score from Baseline to 12 Weeks (Arm 2) [Time frame: Baseline and 12 weeks after enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06543537 · 24-358 · K23NR020219