Clinical trial NCT03287492: RCT of QPS vs General Information Sheet
Official title: A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Malignant Neoplasm
Caregiver
Physician
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-19
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit
timeFrame: Up to 3 years
Secondary outcomes:
measure: Caregivers' perception of helpfulness in communicating with their physicians
timeFrame: Up to 3 years
measure: Patients'/caregivers' overall satisfaction with the consultation
timeFrame: Up to 3 years
measure: Physician's view/overall satisfaction about the information material
timeFrame: Up to 3 years
measure: Change in patient anxiety state scores before and after consultation between the QPS and the GIS
timeFrame: Baseline up to 6 weeks
measure: Average speaking time of patient or physician during the consultation visit affected by QPS
timeFrame: Up to 3 years
measure: Demographic and clinical predictors of patients' perception of helpfulness of a QPS
timeFrame: Up to 3 years
measure: Overall patients' preference between the QPS and GIS in an open label phase
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Joseph A Arthur
role: PRINCIPAL_INVESTIGATOR
References: