NCT00275353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 26, 2006

Status Verified

January 1, 2006

First QC Date

January 10, 2006

Last Update Submit

May 25, 2006

Conditions

Uterine CancerCervical CancerVaginal CancerVulvar Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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).

  • +1 more secondary outcomes

Interventions

Individualized Symptom EducationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Receiving palliative cancer treatment
  • Receiving split course radiation treatment
  • Ovarian cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Uterine NeoplasmsUterine Cervical NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine Cervical DiseasesVaginal DiseasesVulvar Diseases

Study Officials

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

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

July 1, 2003

Study Completion

February 1, 2006

Last Updated

May 26, 2006

Record last verified: 2006-01

Locations

CA(1)