Effectiveness of an Individualized Symptom Education Program (ISEP)

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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 - N/A

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