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NCT Number: NCT06543537

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

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)

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Rachel Pozzar, PhD

CONTACT

[email protected]

857-215-0743

Rachel Pozzar, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Agenda-Setting Intervention

Behavioral

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.

Other names: CASI

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acceptability of Intervention

    Time frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment

    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.

  2. Proportion of Participant-Rated Intervention Helpfulness

    Time frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment

    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."

  3. Proportion of Participant-Rated Intervention Burden

    Time frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment

    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."

  4. 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

    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.

  5. Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)

    Time frame: Baseline and 12 weeks after enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Pozzar, PhD

CONTACT

[email protected]

857-215-0743

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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