The Impact of a Patient Education Intervention for Ambulatory Oncology Patients

NCT02038114 | Completed DMC

• 1 other identifier: 340-2011
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-intestinal Cancer; Lung Cancer; Head and Neck Cancer; Breast Cancer

Keywords

Odette Cancer Centre at Sunnybrook Health Sciences Centre; Toronto; Ontario

Outcome Measures

Primary Outcomes (1)

• 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.

  approx. 6 months for data collection

Secondary Outcomes (1)

• Impact of patient education pamphlets on health-related quality of life (HRQoL)

  approx. 6 months for data collection

Other Outcomes (2)

• Impact of patient pamphlets on self-efficacy

  approx 6 months for data collection

• Impact of patient education pamphlets on patient satisfaction with care

  approx. 6 months for data collection

Study Arms (1)

Instructed to read pamphlets

EXPERIMENTAL

This group will be instructed to read patient education pamphlets.

Behavioral: Instructed to read patient education pamphlets

Interventions

Instructed to read patient education pamphlets BEHAVIORAL

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.

Instructed to read pamphlets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tamara Harth

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: January 16, 2014
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

CA (1)