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Trial record 28 of 1547 for:    rectal cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01152164
Recruitment Status : Unknown
Verified March 2012 by Institute of Oncology Ljubljana.
Recruitment status was:  Active, not recruiting
First Posted : June 29, 2010
Last Update Posted : March 26, 2012
Information provided by:
Institute of Oncology Ljubljana

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.

Condition or disease Intervention/treatment
Rectal Cancer Behavioral: questionnaires

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.

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Study Type : Observational
Actual Enrollment : 167 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
Study Start Date : January 2008
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. To prospectively evaluate the quality of life of patients one year after rectal cancer resection [ Time Frame: one year after the operation ]

Secondary Outcome Measures :
  1. To prospectively evaluate the quality of life of patients at baseline [ Time Frame: before treatment (at baseline) ]
    consecutive patients treated winh capecitabine-based radiochemotherapy

  2. To prospectively evaluate the quality of life of patients two years after rectal cancer resection [ Time Frame: two years after the operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01152164

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Institute of Oncology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana

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Responsible Party: Proff.assist. Vaneja Velenik, MD, PhD, Institute of Oncology Identifier: NCT01152164     History of Changes
Other Study ID Numbers: 125/08
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by Institute of Oncology Ljubljana:
quality of life
rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases