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The purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies is primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.
This pilot study focuses on an intervention (freelisting) designed to elicit supportive oncology communication intentions among the patient-caregiver-provider triad prior to an outpatient oncology encounter. The goal is to shape communication behaviors during the encounter to improve outcomes of the encounter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group triads | No Intervention | ||
| Intervention group triads | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group triads | Behavioral | The intervention consists of a rapid (less than 10-minute) communication intention elicitation exercise (via Freelisting), which is conducted independently with the patient, caregiver, and provider immediately prior to the outpatient oncology encounter. Patients, caregivers, and providers will not be instructed to endorse the Freelist responses that were generated by the intervention prior to the outpatient encounter-leaving the decision to discuss elicited communication intentions during the encounter up to individuals as the conversation naturally occurs. As with the control group, post-encounter survey data will also be collected independently from the patient, caregiver, and the provider, followed by a post-encounter qualitative interview conducted jointly with the patient and caregiver. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate overall recruitment rates. | PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration). | Once all surveys in the sample size are completed, 9 months anticipated |
| Evaluate overall participant satisfaction surveys. | PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire. | Once all surveys in the sample size are completed, 9 months anticipated |
| Explore group differences in communication behaviors during the audio-recorded encounters. | The intervention group will demonstrate increased communication behaviors during the encounter (i.e., breadth of supportive oncology domains discussed) and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication. | Once all encounters in the sample size are completed and transcribed, 9 months anticipated |
| Explore group differences in exit interview outcomes following the encounters. | The intervention group will demonstrate increased communication behaviors and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication. | Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated |
| Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes | Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods. |
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Inclusion Criteria:
patients will:
caregivers will:
providers will:
Exclusion Criteria:
patients and/or caregivers will be excluded if either one or both demonstrate:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center | Carmel | Indiana | 46032 | United States | ||
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center |
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| Once all surveys in the sample size are completed, 9 months anticipated |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| D014625 | Vaginal Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014591 | Uterine Diseases |
| D014623 | Vaginal Diseases |
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