The Impact of a Patient Education Intervention for Ambulatory Oncology Patients

September 5, 2014 updated by: Sunnybrook Health Sciences Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Instructed to read pamphlets
This group will be instructed to read patient education pamphlets.
Behavioral: Instructed to read patient education pamphlets
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Patient Pamphlets on knowledge
Time Frame: approx. 6 months for data collection
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.
approx. 6 months for data collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of patient education pamphlets on health-related quality of life (HRQoL)
Time Frame: approx. 6 months for data collection
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.
approx. 6 months for data collection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of patient pamphlets on self-efficacy
Time Frame: approx 6 months for data collection
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.
approx 6 months for data collection
Impact of patient education pamphlets on patient satisfaction with care
Time Frame: approx. 6 months for data collection
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.
approx. 6 months for data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Tamara Harth, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 340-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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