Communication Effectiveness in Cancer Treatment

NCT02197091 | Completed

• 4 other identifiers: IRB00028889NCI-2014-01478CCCWFU #99514P30CA012197
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Incidence of discrepancies between patient perceptions and the clinical record

  Baseline

Study Arms (1)

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; Other: medical chart review

Interventions

questionnaire administration OTHER

Ancillary studies

Observational (communication in oncology treatment)

medical chart review OTHER

Ancillary studies

Also known as: chart review

Observational (communication in oncology treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults receiving cancer treatment

You may qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Katharine Duckworth, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)