Effectiveness of an Individualized Symptom Education Program (ISEP)
Primary Purpose
Uterine Cancer, Cervical Cancer, Vaginal Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Individualized Symptom Education
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cancer
Eligibility 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
Sites / Locations
- Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer Centre
Outcomes
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)
Full Information
NCT ID
NCT00275353
First Posted
January 10, 2006
Last Updated
May 25, 2006
Sponsor
University of Toronto
Collaborators
Canadian Cancer Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT00275353
Brief Title
Effectiveness of an Individualized Symptom Education Program (ISEP)
Official Title
Effectiveness of an Individualized Symptom Education Program (ISEP) on the Symptom Distress of Women Receiving Radiation for Gynecological Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
Collaborators
Canadian Cancer Trials Group
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cancer, Cervical Cancer, Vaginal Cancer, Vulvar Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
144 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Individualized Symptom Education
Primary Outcome Measure Information:
Title
Symptom distress - measured by the Symptom Distress Scale (SDS) at baseline, end of treatment, and three (3) months post treatment.
Secondary Outcome Measure Information:
Title
All secondary outcomes measured at baseline, end of treatment, and three (3) months post treatment.
Title
Pain - measured by the Brief Pain Inventory-Short Form (BPI-SF)
Title
Fatigue - measured by the Brief Fatigue Inventory (BFI).
Title
Nausea - measured by the nausea subscale (items 4, 5, 7) on the Rhodes Index of Nausea and Vomiting (INVR)
Title
Mood symptoms - measured by the Hospital Anxiety and Depression Scale (HADS).
Title
Pelvic symptoms - measured by the Pelvic Symptom Index (PSI)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karima Velji, RN, MSc, AOCN, PhD(C)
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
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Effectiveness of an Individualized Symptom Education Program (ISEP)
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