Overview

This trial is active, not recruiting.

Condition malignant neoplasm
Treatments questionnaire administration, medical chart review
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date July 2014
End date March 2016
Trial size 100 participants
Trial identifier NCT02197091, CCCWFU #99514, CCCWFU 99514, IRB00028889, NCI-2014-01478, P30CA012197

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
questionnaire administration
Ancillary studies
medical chart review chart review
Ancillary studies

Primary Outcomes

Measure
Patient perceptions about the nature of their therapy and diagnosis
time frame: Baseline
Feasibility, as assessed by accrual rate
time frame: Up to 5 years
Feasibility, as assessed by participation rate
time frame: Up to 5 years

Secondary Outcomes

Measure
Incidence of discrepancies between patient perceptions and the clinical record
time frame: Baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment
Principal investigator Katharine Duckworth, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in August 2016.