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| ID | Type | Description | Link |
|---|---|---|---|
| K23NR020219 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: CASI Intervention | Experimental | Enrolled patients and caregivers will complete:
For each enrolled patient, enrolled clinicians will complete:
Enrolled clinicians will also complete:
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| Arm 2: Control | No Intervention | Enrolled patients and caregivers will complete:
For each enrolled patient, enrolled clinicians will complete:
Enrolled clinicians will also complete:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants. | Pre-consent |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Participant Inclusion Criteria:
Caregiver Inclusion Criteria:
Clinician Inclusion Criteria:
Participant Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Pozzar, PhD | Contact | 857-215-0743 | Rachel_Pozzar@DFCI.HARVARD.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Pozzar, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| 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." | 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." | 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. | 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. | Baseline and 12 weeks after enrollment |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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