RCT of QPS vs General Information Sheet

A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer

This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.

Study Overview

• Status: Active, not recruiting
• Conditions: Caregiver; Advanced Malignant Neoplasm; Physician
• Intervention / Treatment: Other: Questionnaire Administration; Other: Informational Intervention; Other: Informational Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).

SECONDARY OBJECTIVES:

I. To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.

II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.

III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.

IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.

V. To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.

VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.

VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.

VIII. To explore the factors underlying patients' preferences for the QPS or GIS.

OUTLINE: Participants are randomized into 1 of 2 groups.

GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• (Patient participation) First outpatient consultation visit with a palliative care specialist
• (Patient participation) Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, as determined by the patient's physician
• (Patient participation) Ability to read and communicate in English
• (Patient participation) Diagnosis of advanced cancer
• (Patient participation) Signed written informed consent form
• (Caregiver participation) accompanied the patient to the clinic visit
• (Caregiver participation) is identified by the patient as someone who is actively involved in their overall care
• (Caregiver participation) is able to read and communicate in English
• (Caregiver participation) is willing to participate in the study and able to complete the questionnaires
• (Physician participation) a palliative medicine specialist
• (Physician participation) seeing the patient in consultation on the day of the study
• (Physician participation) willing to participate in the study

Exclusion Criteria:

• Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (QPS); Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive QPS; Other: Informational Intervention; Receive GIS
Active Comparator: Group II (GIS); Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive QPS; Other: Informational Intervention; Receive GIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit	Standard statistics including mean, standard deviation, median, range, frequency and percentage will be summarized for variables of interest, such as patients' demographics, clinical characteristics, anxiety state, patients'/caregivers' views about the information material, patients' satisfaction, physicians' views about the information material and consultation, patients' preferences for information, patient preferences for level of involvement in decision-making and patients' overall preference between the question prompt sheet (QPS) and the general information sheet (GIS) at the follow-up visit. Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare continuous variables of interest between the QPS and the GIS. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between categorical variables and helpfulness of information material.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers' perception of helpfulness in communicating with their physicians	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.	Up to 3 years
Patients'/caregivers' overall satisfaction with the consultation	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.	Up to 3 years
Physician's view/overall satisfaction about the information material	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.	Up to 3 years
Change in patient anxiety state scores before and after consultation between the QPS and the GIS	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.	Baseline up to 6 weeks
Average speaking time of patient or physician during the consultation visit affected by QPS	Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare the average speaking time of patient or physician during the consultation visit. Also, general linear model will be applied to assess the effect of QPS on the average speaking time adjusting for clinically and/or statistically important factors.	Up to 3 years
Demographic and clinical predictors of patients' perception of helpfulness of a QPS	Univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on patients' perception of helpfulness of QPS when dichotomizing the answer to the question 3 in the Patient/Caregiver Assessment Questionnaire ("Agree/Strongly Agree"=Helpful versus the rest).	Up to 3 years
Overall patients' preference between the QPS and GIS in an open label phase	Will estimate the preference of information material with 95% confidence intervals. Also, univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on overall patients' preference between QPS and GIS.	Up to 3 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Joseph A Arthur, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2017-0028 (Other Identifier: M D Anderson Cancer Center); NCI-2018-01052 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No