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Clinical Trials/NCT01152164
NCT01152164
Unknown
Not Applicable

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

Institute of Oncology Ljubljana1 site in 1 country167 target enrollmentJanuary 2008
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Institute of Oncology Ljubljana
Enrollment
167
Locations
1
Primary Endpoint
To prospectively evaluate the quality of life of patients one year after rectal cancer resection
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
September 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

To prospectively evaluate the quality of life of patients one year after rectal cancer resection

Time Frame: one year after the operation

Secondary Outcomes

  • To prospectively evaluate the quality of life of patients at baseline(before treatment (at baseline))
  • To prospectively evaluate the quality of life of patients two years after rectal cancer resection(two years after the operation)

Study Sites (1)

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