Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntervention group triads
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.
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients will: 1. be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease), 2. not be receiving specialty palliative care or hospice, 3. read/speak English, and 4. be able to provide written informed consent. * caregivers will: 1. identify as the individual who is primarily involved in the patient's care, 2. be able to attend the oncology encounter, 3. read/speak English, and 4. be able to provide written informed consent. * providers will: 1. specialize in gynecologic oncology, and 2. provide outpatient care at IUSCCC gynecologic oncology clinic.
Exclusion criteria
patients and/or caregivers will be excluded if either one or both demonstrate: 1. cognitive impairment, or 2. speech/hearing difficulties precluding participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate overall recruitment rates. | Once all surveys in the sample size are completed, 9 months anticipated | PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration). |
| Evaluate overall participant satisfaction surveys. | Once all surveys in the sample size are completed, 9 months anticipated | PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire. |
| Explore group differences in communication behaviors during the audio-recorded encounters. | Once all encounters in the sample size are completed and transcribed, 9 months anticipated | 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. |
| Explore group differences in exit interview outcomes following the encounters. | Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated | 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. |
| Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes | Once all surveys in the sample size are completed, 9 months anticipated | Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods. |
Countries
United States
Outcome results
None listed