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.
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Symptom distress - measured by the Symptom Distress Scale (SDS) at baseline, end of treatment, and three (3) months post treatment.
Secondary Outcome
All secondary outcomes measured at baseline, end of treatment, and three (3) months post treatment.
Condition
Uterine Cancer
Intervention
Individualized Symptom Education
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
144
Start Date
July 2003
Completion Date
February 2006
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
Gender
Female
Ages
18 Years - 0 Years
Accepts Healthy Volunteers
No
Contacts
Karima Velji, RN, MSc, AOCN, PhD(C), ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00275353
Organization ID
9848
Secondary IDs
014144
Study Sponsor
University of Toronto
Collaborators
Canadian Cancer Trials Group
Study Sponsor
Karima Velji, RN, MSc, AOCN, PhD(C), Principal Investigator, University of Toronto
Verification Date
January 2006