Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer

Study Overview
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Brief Summary
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The goal of this study is gathering informations about patients' quality of life after combined modality treatment of rectal cancer to evaluate how combined modality treatment for rectal cancer affects patients' quality of life. The findings of this study may provide us important information that can be used in treatment decision and to develop programs to improve quality of life of patients with rectal cancer.

Detailed Description
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Over the last two decades, rectal cancer research has lead to better understanding of disease behaviour, resulting in more efficient treatments and higher prevalence of cancer survivors.Due to aggressive therapy, rectal cancer survivors can exhibit late sequelae of treatment, most common being impaired bowel, voiding, sexual malfunctioning and quality of life impairment. In order to determine the impact of rectal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals evaluating their physical symptoms, physical and social functioning and overall quality of life.Medical and sociodemographic factors that might be predictive will be tested.

Official Title
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Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Behavioral: questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically verified adenocarcinoma of the rectum, clinical stage II or III (IUCC TNM classification 2002); no prior radiotherapy and/or chemotherapy; World Health Organisation (WHO) performance status < 2; age at diagnosis of 18 or older; and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease) mentally fit to complete questionnaires Exclusion Criteria: a history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix rendered the patient ineligible.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rectal cancer patients<br> | Behavioral: questionnaires<br>* Quality of life assessment using questionnaires EORTC QLQ C30 and 38 at baseline, one year and two years after the surgery of rectal cancer, treated with preoperative capecitabine based radiochemotherapy<br>* Other names: EORTC QLQ C30, EORTC QLQ C38;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prospectively evaluate the quality of life of patients one year after rectal cancer resection |  | one year after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prospectively evaluate the quality of life of patients at baseline | consecutive patients treated winh capecitabine-based radiochemotherapy | before treatment (at baseline) | 
| To prospectively evaluate the quality of life of patients two years after rectal cancer resection |  | two years after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, rectal cancer