RCT of QPS vs General Information Sheet
A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer
2 other identifiers
interventional
207
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
January 20, 2026
January 1, 2026
10.3 years
September 15, 2017
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Caregivers' perception of helpfulness in communicating with their physicians
Up to 3 years
Patients'/caregivers' overall satisfaction with the consultation
Up to 3 years
Physician's view/overall satisfaction about the information material
Up to 3 years
Average speaking time of patient or physician during the consultation visit affected by QPS
Up to 3 years
Overall patients' preference between the QPS and GIS in an open label phase
Up to 3 years
- +2 more secondary outcomes
Study Arms (2)
Group I (QPS)
EXPERIMENTALParticipants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Group II (GIS)
ACTIVE COMPARATORParticipants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Interventions
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Arthur J, Pawate V, Lu Z, Yennurajalingam S, Azhar A, Reddy A, Epner D, Hui D, Tanco K, Delgado Guay MO, Vidal M, Chen M, Bruera E. Helpfulness of Question Prompt Sheet for Patient-Physician Communication Among Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311189. doi: 10.1001/jamanetworkopen.2023.11189.
PMID: 37129892DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph A Arthur
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 19, 2017
Study Start
September 25, 2017
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
January 20, 2026
Record last verified: 2026-01