RCT of QPS vs General Information Sheet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Malignant Neoplasm Caregiver Physician

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I (QPS)

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

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive QPS

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (GIS)

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

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive GIS

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Informational Intervention

Receive QPS

Intervention Type OTHER

Informational Intervention

Receive GIS

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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