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

NCT06543537RecruitingNAINTERVENTIONAL

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)

Key Facts

Lead Sponsor

Dana-Farber Cancer Institute

Enrollment

112

Start Date

2025-01-17

Completion Date

2026-05-31

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Collaborative Agenda-Setting Intervention

Conditions

Ovarian CancerOvarian NeoplasmsOvarian Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Enrollment Rate

The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.

Time frame: Pre-consent

Secondary Outcomes

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.

Time frame: 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."

Time frame: 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."

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)

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.

Time frame: 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.

Time frame: Baseline and 12 weeks after enrollment

Locations

Dana-Farber Cancer Institute, Boston, United States

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.