Ovarian Cancer, Ovarian Carcinoma, Ovarian Neoplasms
Conditions
Keywords
Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
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.
Interventions
BEHAVIORALCollaborative 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 communication resources, while patients and caregivers receive tailored educational materials and navigation to supportive care services.
Sponsors
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Pre-consent | The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | 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. |
| Proportion of Participant-Rated Intervention Helpfulness | 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." |
| Proportion of Participant-Rated Intervention Burden | 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." |
| Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1) | 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. |
| Change in FACT-G Score from Baseline to 12 Weeks (Arm 2) | 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. |
Countries
United States
Contacts
CONTACTRachel Pozzar, PhD
PRINCIPAL_INVESTIGATORRachel Pozzar, PhD
Dana-Farber Cancer Institute
Outcome results
None listed