A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Patient perceptions about the nature of their therapy and diagnosis
Study Overview
Brief Summary
This pilot research trial studies communication effectiveness in cancer treatment. Studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy.
SECONDARY OBJECTIVES:
I. To explore possible correlation between various patient satisfaction indicators and discrepant patient perceptions about their care.
II. To gather exploratory data on patient characteristics that might correlate with discrepant patient perceptions about their care.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a diagnosis of cancer
- •Patients must have been in active therapy for cancer for at least one month or have a scheduled surgical treatment of their cancer
- •Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Patient perceptions about the nature of their therapy and diagnosis
Time Frame: Baseline
The precision of agreement between patient's and doctor's responses about the intent of therapy will be assessed. The level of agreement between the questions as answered by the patient on the Prognosis Instrument and by the doctor on the Doctor Questionnaire will be assessed. Agreement will be measured as either "yes" (meaning the doctor and patient responses match exactly) or "no" (any other combination, if both doctor and patient responded). The primary measure of agreement will be the Kappa statistic; the Kappa and its corresponding 95% confidence interval (CI) will be reported.
Feasibility, as assessed by accrual rate
Time Frame: Up to 5 years
Accrual will be estimated as the number of patients accrued divided by the months of accrual. A 95% confidence interval for the monthly accrual will be calculated based on the Poisson distribution.
Feasibility, as assessed by participation rate
Time Frame: Up to 5 years
The participation rate will be estimated as the number of patients who are participants divided by the number eligible. This estimate will be calculated separately by cancer type to see what cancer types are more or less likely to participate. An exact 95% CI will be calculated for this estimate of each cancer type.
Secondary Outcomes
- Incidence of discrepancies between patient perceptions and the clinical record(Baseline)