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Completed

NCT Number: NCT02197091

Communication Effectiveness in Cancer 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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

medical chart review

Other

Ancillary studies

Other names: chart review

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Incidence of discrepancies between patient perceptions and the clinical record

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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