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

Phase 2
18 Years
Not Enrolling
Uterine Cancer, Cervical Cancer, Vaginal Cancer, Vulvar Cancer

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Trial Information

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

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

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).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Karima Velji, RN, MSc, AOCN, PhD(C)

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Toronto


Canada: Health Canada

Study ID:




Start Date:

July 2003

Completion Date:

February 2006

Related Keywords:

  • Uterine Cancer
  • Cervical Cancer
  • Vaginal Cancer
  • Vulvar Cancer
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms