Effectiveness of an Individualized Symptom Education Program (ISEP)
Effectiveness of an Individualized Symptom Education Program (ISEP) on the Symptom Distress of Women Receiving Radiation for Gynecological Cancer.
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.
研究概览
详细说明
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).
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大
- Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
研究衡量的是什么?
主要结果指标
结果测量 |
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Symptom distress - measured by the Symptom Distress Scale (SDS) at baseline, end of treatment, and three (3) months post treatment.
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次要结果测量
结果测量 |
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All secondary outcomes measured at baseline, end of treatment, and three (3) months post treatment.
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Pain - measured by the Brief Pain Inventory-Short Form (BPI-SF)
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Fatigue - measured by the Brief Fatigue Inventory (BFI).
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Nausea - measured by the nausea subscale (items 4, 5, 7) on the Rhodes Index of Nausea and Vomiting (INVR)
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Mood symptoms - measured by the Hospital Anxiety and Depression Scale (HADS).
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Pelvic symptoms - measured by the Pelvic Symptom Index (PSI)
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合作者和调查者
调查人员
- 首席研究员:Karima Velji, RN, MSc, AOCN, PhD(C)、University of Toronto
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Individualized Symptom Education的临床试验
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne主动,不招人