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

NCT01152164 | Unknown

• 1 other identifier: 125/08
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

quality of life; rectal cancer

Outcome Measures

Primary Outcomes (1)

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

  one year after the operation

Secondary Outcomes (2)

• 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 Arms (1)

rectal cancer patients

Behavioral: questionnaires

Interventions

questionnaires BEHAVIORAL

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

Also known as: EORTC QLQ C30, EORTC QLQ C38

rectal cancer patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• a history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix rendered the patient ineligible.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology

Ljubljana, Slovenia, 1000, Slovenia

Location

Related Publications (6)

• 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.

  PMID: 8433390 BACKGROUND

• 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.

  PMID: 10448266 BACKGROUND

• 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.

  PMID: 17058130 BACKGROUND

• 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.

  PMID: 14722043 BACKGROUND

• 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.

  PMID: 12619150 BACKGROUND

• 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.

  PMID: 9440735 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: January 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

SL (1)