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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01152164
Enrollment
167
Registered
2010-06-29
Start date
2008-01-31
Completion date
2012-09-30
Last updated
2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

quality of life, rectal cancer

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.

Interventions

BEHAVIORALquestionnaires

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

Sponsors

Institute of Oncology Ljubljana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To prospectively evaluate the quality of life of patients one year after rectal cancer resectionone year after the operation

Secondary

MeasureTime frameDescription
To prospectively evaluate the quality of life of patients at baselinebefore treatment (at baseline)consecutive patients treated winh capecitabine-based radiochemotherapy
To prospectively evaluate the quality of life of patients two years after rectal cancer resectiontwo years after the operation

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026