A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 207
- Locations
- 2
- Primary Endpoint
- Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group I (QPS)
Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Intervention: Informational Intervention (Other)
Group I (QPS)
Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Intervention: Questionnaire Administration (Other)
Group II (GIS)
Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Intervention: Informational Intervention (Other)
Group II (GIS)
Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit
Time Frame: 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 Outcomes
- Change in patient anxiety state scores before and after consultation between the QPS and the GIS(Baseline up to 6 weeks)
- 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)
- Demographic and clinical predictors of patients' perception of helpfulness of a QPS(Up to 3 years)
- Overall patients' preference between the QPS and GIS in an open label phase(Up to 3 years)
- 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)
- Change in patient anxiety state scores before and after consultation between the QPS and the GIS(Baseline up to 6 weeks)
- Demographic and clinical predictors of patients' perception of helpfulness of a QPS(Up to 3 years)