The Impact of a Patient Education Intervention for Ambulatory Oncology Patients
Primary Purpose
Gastro-intestinal Cancer, Lung Cancer, Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Instructed to read patient education pamphlets
Sponsored by
About this trial
This is an interventional supportive care trial for Gastro-intestinal Cancer focused on measuring Odette Cancer Centre at Sunnybrook Health Sciences Centre, Toronto, Ontario
Eligibility Criteria
Inclusion Criteria:
- receiving treatment at the Odette Cancer Centre or Breast Cancer Centre at Sunnybrook Hospital
- over the age of 18
- English-speaking and able to read and complete a survey in English
Exclusion Criteria (patients will be withdrawn from study in the event that...):
- The patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
- The patient wishes to discontinue the study
- The patient is noted to be cognitively impaired during the course of the study such that he cannot complete a questionnaire reliably or physically impaired such that it is too burdensome
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Instructed to read pamphlets
Arm Description
This group will be instructed to read patient education pamphlets.
Outcomes
Primary Outcome Measures
Impact of Patient Pamphlets on knowledge
Participants who are asked to read patient education pamphlets on symptoms will complete our survey subsequent to reading which test their knowledge about pamphlets. We will be about to conclude later whether reading the pamphlets was correlated with greater knowledge when compared to the control group who did not read the pamphlets.
Secondary Outcome Measures
Impact of patient education pamphlets on health-related quality of life (HRQoL)
This study will also assess whether the intervention group (that read the pamphlets) differed from the control group (who did not read the pamphlets) in terms of health-related quality of life.
Full Information
NCT ID
NCT02038114
First Posted
November 25, 2013
Last Updated
September 5, 2014
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02038114
Brief Title
The Impact of a Patient Education Intervention for Ambulatory Oncology Patients
Official Title
The Impact of a Patient Education Intervention on Knowledge, Self-efficacy, Symptom Burden, Health Related Quality of Life and Satisfaction With the Experience of Care for Oncology Ambulatory Patients Post Completion of the Edmonton Screening Assessment System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will test the impact of newly created and available symptom management patient education brochures on symptom burden [measured via the Edmonton Symptom Assessment System (ESAS)], health-related quality of life [measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are designed for oncology patients in order to provide a response to symptom screening and are now a standard part of care. Symptom screening occurs at each visit as patients are required to fill out ESAS, that asks about their experience with the occurence and severity of symptoms. The intent of the patient brochures are to acknowledge the screen, validate the symptom and provide knowledge of self-management strategies for symptoms. The brochures also provide information to patients about when and how to seek further help from their oncology team. The hope is that patients will experience a useful response to their screen with all levels of symptoms-from 0-10 in severity
It is hypothesized that the addition of patient education symptom management pamphlets on 7 of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety, fatigue, dyspnea and pain) will provide new and meaningful information which will build knowledge, validate the patient's experience of the symptom, lead to increased satisfaction with care, improved self efficacy in managing and accessing help for the symptom and therefore improved health related quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-intestinal Cancer, Lung Cancer, Head and Neck Cancer, Breast Cancer
Keywords
Odette Cancer Centre at Sunnybrook Health Sciences Centre, Toronto, Ontario
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Instructed to read pamphlets
Arm Type
Experimental
Arm Description
This group will be instructed to read patient education pamphlets.
Intervention Type
Behavioral
Intervention Name(s)
Instructed to read patient education pamphlets
Intervention Description
The intervention in this study is the administration of patient education pamphlets and instructions to read them. Half of all patients who participate in this study will be required to read pamphlets on symptoms that are relevant to them (i.e. symptoms that they are experiencing). Subsequent to reading pamphlets, patients will complete study questionnaires to assess their impact.
Primary Outcome Measure Information:
Title
Impact of Patient Pamphlets on knowledge
Description
Participants who are asked to read patient education pamphlets on symptoms will complete our survey subsequent to reading which test their knowledge about pamphlets. We will be about to conclude later whether reading the pamphlets was correlated with greater knowledge when compared to the control group who did not read the pamphlets.
Time Frame
approx. 6 months for data collection
Secondary Outcome Measure Information:
Title
Impact of patient education pamphlets on health-related quality of life (HRQoL)
Description
This study will also assess whether the intervention group (that read the pamphlets) differed from the control group (who did not read the pamphlets) in terms of health-related quality of life.
Time Frame
approx. 6 months for data collection
Other Pre-specified Outcome Measures:
Title
Impact of patient pamphlets on self-efficacy
Description
This study will assess whether the intervention group (who read the patient education pamphlets) differed from the control group (that did not read the pamphlets) in terms of self-efficacy. More specifically, this study will evaluate self-efficacy in terms of patient confidence in managing their symptoms.
Time Frame
approx 6 months for data collection
Title
Impact of patient education pamphlets on patient satisfaction with care
Description
This study will evaluate whether the intervention group (who read patient education pamphlets) differed from the control group (who did not), in terms of patient satisfaction with care. We predict that patients who read the education pamphlets will be more satisfied with their care.
Time Frame
approx. 6 months for data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
receiving treatment at the Odette Cancer Centre or Breast Cancer Centre at Sunnybrook Hospital
over the age of 18
English-speaking and able to read and complete a survey in English
Exclusion Criteria (patients will be withdrawn from study in the event that...):
The patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
The patient wishes to discontinue the study
The patient is noted to be cognitively impaired during the course of the study such that he cannot complete a questionnaire reliably or physically impaired such that it is too burdensome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Harth
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Impact of a Patient Education Intervention for Ambulatory Oncology Patients
We'll reach out to this number within 24 hrs