Communication Effectiveness in Cancer Treatment

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. OUTLINE: Patients complete questionnaires, including the Functional Assessment of Cancer Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary. After completion of study, patients are followed up for 5 years.

Official Title
-----------------
A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Other: medical chart review


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (communication in oncology treatment)<br>Patients complete questionnaires, including the FACIT-TS-G, the FACIT-Sp12, the MOS-SSS, and the DT. Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary. | Other: questionnaire administration<br>* Ancillary studies<br>Other: medical chart review<br>* Ancillary studies<br>* Other names: chart review;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perceptions about the nature of their therapy and diagnosis | 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. | Baseline | 
| Feasibility, as assessed by accrual rate | 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. | Up to 5 years | 
| Feasibility, as assessed by participation rate | 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. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of discrepancies between patient perceptions and the clinical record | The FACIT-TS-G, FACIT-Sp12, MOS-SSS, and DT instruments will be used to see if there might be a relationship between the observed scores and discrepancies in the answers provided by patients and the clinical record. Patient characteristics will be assessed for differences between the two records. Means, standard deviations, and medians will be calculated for each of the scores, stratified by discrepancy type for those who do not match and those who match perfectly. These data will be analyzed by analysis of variance. | Baseline |