Effectiveness of an Individualized Symptom Education Program (ISEP)

Learn more about:
Related Clinical Trial
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer Retrospective Study of Brachytherapy Groningen International Study on Sentinel Nodes in Vulvar Cancer-III Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study Education, Immigration and HPV Vaccination: an Informational Randomized Trial Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Serial MRI Scans During Radiation Therapy A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Cisplatin+Pembrolizumab+RT in Vulvar Cancer Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery MR-HIFU for Recurrent Gynaecological Cancer Pelvic Floor Disorders in Survivors of Gynecologic Malignancies Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Validation of a Nutrition Screening Tool A Survivorship Care Plan for Gynaecological Cancer Patients Self-Advocacy Serious Game in Advanced Cancer Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) Chemoradiation-Induced Nausea and Emesis: Quality of Life A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies ChemoFx® PRO – A Post-Market Data Collection Study Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Image-Guided Gynecologic Brachytherapy Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer Topical Imiquimod in Treating Patients With Recurrent Paget’s Disease of the Vulva Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence CaptHPV : Validation of the Method “CaptHPV” for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers Effectiveness of an Individualized Symptom Education Program (ISEP) A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer OCT-AF Imaging of Pre-cancers of Vulva and Cervix Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer Sentinel Node Extended in Squamous Cell Vulvar Cancer Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

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

      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


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.


Uterine Cancer


Individualized Symptom Education


* 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


Estimated Enrollment


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

          -  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




18 Years - 0 Years

Accepts Healthy Volunteers



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

Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

University of Toronto


 Canadian Cancer Trials Group

Study Sponsor

Karima Velji, RN, MSc, AOCN, PhD(C), Principal Investigator, University of Toronto

Verification Date

January 2006