ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effectiveness of an Individualized Symptom Education Program (ISEP)

This study has been completed.

Sponsors and Collaborators: University of Toronto
National Cancer Institute of Canada
Information provided by: University of Toronto
ClinicalTrials.gov Identifier: NCT00275353
  Purpose

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.


Condition Intervention Phase
Uterine Cancer
Cervical Cancer
Vaginal Cancer
Vulvar Cancer
Behavioral: Individualized Symptom Education
Phase II

MedlinePlus related topics:   Cancer    Cervical Cancer    Nausea and Vomiting    Uterine Cancer    Vaginal Cancer    Vulvar Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Effectiveness of an Individualized Symptom Education Program (ISEP) on the Symptom Distress of Women Receiving Radiation for Gynecological Cancer.

Further study details as provided by University of Toronto:

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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment:   144
Study Start Date:   July 2003
Estimated Study Completion Date:   February 2006

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275353

Locations
Canada, Ontario
Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer Centre    
      Toronto, Ontario, Canada

Sponsors and Collaborators
University of Toronto
National Cancer Institute of Canada

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


Study ID Numbers:   9848, 014144, 14927, 12048, 266-2003, 03-0487-CE
First Received:   January 10, 2006
Last Updated:   May 25, 2006
ClinicalTrials.gov Identifier:   NCT00275353
Health Authority:   Canada: Health Canada

Study placed in the following topic categories:
Vaginal Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Vaginal cancer
Urogenital Neoplasms
Vaginal Diseases
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Vulvar Neoplasms
Uterine Neoplasms
Vulvar Diseases
Vulvar cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers