Communication Effectiveness in Cancer Treatment

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197091
• Other study ID #: IRB00028889
• Secondary ID: NCI-2014-01478IR
• Status: Completed
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• questionnaire administration
Ancillary studies
• medical chart review
Ancillary studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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