RCT of QPS vs General Information Sheet

Not Applicable

Active, not recruiting

• Conditions: Caregiver; Advanced Malignant Neoplasm; Physician
• Interventions: Other: Informational Intervention; Other: Questionnaire Administration

• Registration Number: NCT03287492
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Study Start: 2017-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (GIS)	Questionnaire Administration	Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Group II (GIS)	Informational Intervention	Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Group I (QPS)	Questionnaire Administration	Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Group I (QPS)	Informational Intervention	Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.

Primary Outcome Measures

Name	Time	Method
Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit	Up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Caregivers' perception of helpfulness in communicating with their physicians	Up to 3 years	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Patients'/caregivers' overall satisfaction with the consultation	Up to 3 years	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Change in patient anxiety state scores before and after consultation between the QPS and the GIS	Baseline up to 6 weeks	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Overall patients' preference between the QPS and GIS in an open label phase	Up to 3 years	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.
Average speaking time of patient or physician during the consultation visit affected by QPS	Up to 3 years	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.
Demographic and clinical predictors of patients' perception of helpfulness of a QPS	Up to 3 years	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).
Physician's view/overall satisfaction about the information material	Up to 3 years	Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States