Effectiveness of an Individualized Symptom Education Program (ISEP)

May 25, 2006 updated by: University of Toronto

Effectiveness of an Individualized Symptom Education Program (ISEP) on the Symptom Distress of Women Receiving Radiation for Gynecological Cancer.

The purpose of this study is to examine whether an Individualized Symptom Education Program (ISEP) is helpful to women to manage their symptoms when they are receiving radiation therapy for gynecological cancer.

It is expected that women who participate in the ISEP program will be better able to manage their symptoms and exprience less distress than women who receive usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who have radiation therapy for gynecological cancer may experience a number of symptoms including fatigue, pain, nausea, pelvic symptoms (urgent and frequent urination and bowel movements, vaginal discharge, vaginal itching, skin irritation), anxiety and depression. We know that individualized education programs have helped people with other types of cancer to better manage their symptoms, and we would like to find out whether such interventions are helpful to women with gynecological cancers.

This study will compare two types of education: 1) the symptom education program currently in place (usual care), and 2) an individualized symptom education program (ISEP). This study is being conducted because we do not know if one type of education in patients who receive radiation for gynecological cancers is better than the other. Both types of education are are described below.

Usual care: Usual symptom education during radiation treatment consists of receiving verbal and written education from a radiation oncologist, nurse and radiation therapist, and other members of the interdisciplinary team. The radiation therapist will see the patient everyday during her radiation treatment and her doctor and nurse will see her on a weekly basis. The patient will also see other members of the team, such as a dietitian and social worker as required.

Individualized symptom education: Individualized symptom education will include usual symptom education and also an education program that focuses on symptom management. The patient will meet with an advanced practice nurse on a weekly basis for six sessions of about 30 minutes each. The advanced practice nurse will ask about the symptoms the paient is experiencing and those that are most bothersome to her. She will be given information about specific strategies to manage those symptoms, including written education materials. These strategies will be based on published best practice guidelines.

Data on symptom experience will be collected at 3 points: at baseline, after completion of the education program (end of external beam treatment), and at 3 months following completion of the education program (3 months following completion of external radiation treatment).

Study Type

Interventional

Enrollment

144

Phase

  • Phase 2

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
        • Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer 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

Female

Description

Inclusion Criteria:

  • First time diagnosis of cancer of the uterus, cervix, vagina, or vulva
  • Beginning first time radical radiation therapy to the pelvis of at least 4000cGy (with or without brachytherapy after external beam treatment and with or without concurrent chemotherapy)
  • At least 18 years of age and over
  • Able to speak and understand English

Exclusion Criteria:

  • Receiving palliative cancer treatment
  • Receiving split course radiation treatment
  • Ovarian cancer

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Symptom distress - measured by the Symptom Distress Scale (SDS) at baseline, end of treatment, and three (3) months post treatment.

Secondary Outcome Measures

Outcome Measure
All secondary outcomes measured at baseline, end of treatment, and three (3) months post treatment.
Pain - measured by the Brief Pain Inventory-Short Form (BPI-SF)
Fatigue - measured by the Brief Fatigue Inventory (BFI).
Nausea - measured by the nausea subscale (items 4, 5, 7) on the Rhodes Index of Nausea and Vomiting (INVR)
Mood symptoms - measured by the Hospital Anxiety and Depression Scale (HADS).
Pelvic symptoms - measured by the Pelvic Symptom Index (PSI)

Collaborators and Investigators

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

Sponsor

University of Toronto

Collaborators

Canadian Cancer Trials Group

Investigators

  • Principal Investigator: Karima Velji, RN, MSc, AOCN, PhD(C), University of Toronto

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

July 1, 2003

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Estimate)

May 26, 2006

Last Update Submitted That Met QC Criteria

May 25, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9848
  • 14927
  • 014144
  • 12048
  • 266-2003
  • 03-0487-CE

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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