Communication Effectiveness in Cancer Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: questionnaire administration; Other: medical chart review

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults receiving cancer treatment

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (communication in oncology treatment); 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; Ancillary studies; Other: medical chart review; Ancillary studies; 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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katharine Duckworth, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB00028889; P30CA012197 (U.S. NIH Grant/Contract); NCI-2014-01478 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU #99514 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No