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

NCT ID: NCT01152164

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

rectal cancer patients

questionnaires

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

EORTC QLQ C30, EORTC QLQ C38

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Oncology Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Institute of Oncology

Locations

Institute of Oncology

Ljubljana, Slovenia, Slovenia

Countries

Slovenia

References

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.

Reference Type: BACKGROUND

PMID: 8433390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10448266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17058130 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14722043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12619150 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9440735 (View on PubMed)

Other Identifiers

125/08

Identifier Type: -

Identifier Source: org_study_id