Clinical trial NCT01152164: Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
Official title: Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: quality of life
rectal cancer
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients with rectal cancer stage II and III, treated with capecitabine-based preoperative radiochemotherapy from 1.1.2008 till 31.12.2009.

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.

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.

Primary outcomes:
measure: To prospectively evaluate the quality of life of patients one year after rectal cancer resection
timeFrame: one year after the operation
Secondary outcomes:
measure: To prospectively evaluate the quality of life of patients at baseline
timeFrame: before treatment (at baseline)
measure: To prospectively evaluate the quality of life of patients two years after rectal cancer resection
timeFrame: two years after the operation
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology
Study officials:
References:
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
citation: Sprangers MA, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999 Feb;35(2):238-47. doi: 10.1016/s0959-8049(98)00357-8.
citation: Moriya Y. Function preservation in rectal cancer surgery. Int J Clin Oncol. 2006 Oct;11(5):339-43. doi: 10.1007/s10147-006-0608-z.
citation: Rauch P, Miny J, Conroy T, Neyton L, Guillemin F. Quality of life among disease-free survivors of rectal cancer. J Clin Oncol. 2004 Jan 15;22(2):354-60. doi: 10.1200/JCO.2004.03.137.
citation: Parker PA, Baile WF, de Moor Cd, Cohen L. Psychosocial and demographic predictors of quality of life in a large sample of cancer patients. Psychooncology. 2003 Mar;12(2):183-93. doi: 10.1002/pon.635.
citation: Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139.