Ovarian CancerNCT06543537
Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
A study testing Collaborative Agenda-Setting Intervention in people with Ovarian Cancer and Ovarian Neoplasms, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
- What is being tested?
- Collaborative Agenda-Setting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Rachel Pozzar, PhD, 857-215-0743, Rachel_Pozzar@dfci.harvard.edu
Rachel Pozzar, PhD
About this study
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)
Read the 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.
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
- Being tested
- Collaborative Agenda-Setting Intervention
- Keywords
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Agenda-Setting InterventionBehavioural
Also called CASI
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CASI Intervention | Experimental | 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 Receives: Behavioral: Collaborative Agenda-Setting Intervention |
| Arm 2: Control | No 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
Measured: Pre-consent
Secondary outcomes (5)
Acceptability of Intervention
Feasibility of an efficacy trial is defined as a mean Acceptability of Intervention Measure score of ≥4.0 among participants in the intervention group. The Acceptability of Intervention Measure is a four-item questionnaire rated on a 5 point Likert-type scale from 5 "Strongly Agree" to "1 Strongly Disagree" with a total scores range of 4 to 20. A higher score represents greater intervention acceptability.
Measured: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Proportion of Participant-Rated Intervention Helpfulness
Feasibility of an efficacy trial is defined as ≥60% of participants in the intervention group agreeing with the survey item "the CASI was helpful to me."
Measured: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Proportion of Participant-Rated Intervention Burden
Feasibility of an efficacy trial is defined as ≤20% of participants in the intervention group agreeing with the survey item "the CASI placed a considerable burden on me."
Measured: 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)
Defined as the numeric proportion of participants that experience a clinically meaningful improvement in health-related quality of life from baseline to follow-up. A clinically meaningful improvement is defined as an increase of ≥4 points in the Functional Assessment of Cancer Therapy - General (FACT-G) total score. The FACT-G is a 27-item questionnaire rated on a 5 point Likert-type scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. A higher score represents greater participant well-being.
Measured: Baseline and 12 weeks after enrollment
Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)
Defined as the numeric proportion of patient participants that experience a clinically meaningful improvement in health-related quality of life from baseline to follow-up. A clinically meaningful improvement is defined as an increase of ≥4 points in the FACT-G total score.
Measured: Baseline and 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start17 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rachel Pozzar, Dana-Farber Cancer Institute
- Investigators
- Rachel Pozzar, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543537
- Sponsor's protocol ID
- 24-358
- Other IDs
- K23NR020219
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06543537
- Acronym / sponsor ID
- 24-358
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
- Keywords
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CASI Intervention | Experimental | Behavioral: Collaborative Agenda-Setting InterventionEnrolled 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 |
| Arm 2: Control | No 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Agenda-Setting InterventionAlso: CASIA 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. | Behavioural | Arm 1: CASI Intervention |
Primary outcome
Enrollment Rate
Time frame: Pre-consent
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Pozzar, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Agenda-Setting Intervention in people with Ovarian Cancer and Ovarian Neoplasms, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Pozzar, PhD (857-215-0743, Rachel_Pozzar@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Pre-consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.