Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer - Full Text View

Purpose

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.

Condition	Intervention
Rectal Cancer	Behavioral: questionnaires

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Institute of Oncology Ljubljana:

Primary Outcome Measures:

To prospectively evaluate the quality of life of patients one year after rectal cancer resection [ Time Frame: one year after the operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To prospectively evaluate the quality of life of patients at baseline [ Time Frame: before treatment (at baseline) ] [ Designated as safety issue: No ]
consecutive patients treated winh capecitabine-based radiochemotherapy
To prospectively evaluate the quality of life of patients two years after rectal cancer resection [ Time Frame: two years after the operation ] [ Designated as safety issue: No ]

Enrollment:	167
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
rectal cancer patients	Behavioral: questionnaires 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 Other Name: EORTC QLQ C30, EORTC QLQ C38

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152164

Locations

Slovenia
Institute of Oncology
Ljubljana, Slovenia, 1000

Sponsors and Collaborators

Institute of Oncology Ljubljana

More Information

Publications:

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.

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.

Moriya Y. Function preservation in rectal cancer surgery. Int J Clin Oncol. 2006 Oct;11(5):339-43. Review.

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.

Parker PA, Baile WF, de Moor C, Cohen L. Psychosocial and demographic predictors of quality of life in a large sample of cancer patients. Psychooncology. 2003 Mar;12(2):183-93.

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.

Responsible Party:	Proff.assist. Vaneja Velenik, MD, PhD, Institute of Oncology
ClinicalTrials.gov Identifier:	NCT01152164 History of Changes
Other Study ID Numbers:	125/08
Study First Received:	June 25, 2010
Last Updated:	March 23, 2012
Health Authority:	Slovenia: Ethics Committee

Keywords provided by Institute of Oncology Ljubljana:

quality of life
rectal cancer

Additional relevant MeSH terms:

Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013