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

• Conditions: Rectal Cancer
• Interventions: Behavioral: questionnaires

• Registration Number: NCT01152164
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rectal cancer patients	questionnaires	-

Primary Outcome Measures

Name	Time	Method
To prospectively evaluate the quality of life of patients one year after rectal cancer resection	one year after the operation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Oncology; 🇸🇮 Ljubljana, Slovenia