RCT of QPS vs General Information Sheet

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Physician; Caregiver; Advanced Malignant Neoplasm

Treatments: Other: Informational Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03287492

NCI-2018-01052 (Registry Identifier)

2017-0028 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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207 participants in 2 patient groups

Group I (QPS)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention

Other: Informational Intervention

Group II (GIS)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention

Other: Informational Intervention