Clinical trial NCT02038114: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-intestinal Cancer
Lung Cancer
Head and Neck Cancer
Breast Cancer
Keywords: Odette Cancer Centre at Sunnybrook Health Sciences Centre
Toronto
Ontario
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Impact of Patient Pamphlets on knowledge
timeFrame: approx. 6 months for data collection
Secondary outcomes:
measure: Impact of patient education pamphlets on health-related quality of life (HRQoL)
timeFrame: approx. 6 months for data collection
Other outcomes:
measure: Impact of patient pamphlets on self-efficacy
timeFrame: approx 6 months for data collection
measure: Impact of patient education pamphlets on patient satisfaction with care
timeFrame: approx. 6 months for data collection
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Tamara Harth
role: PRINCIPAL_INVESTIGATOR
References: