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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Institute of Oncology Ljubljana.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier:
NCT01152164
First received: June 25, 2010
Last updated: March 23, 2012
Last verified: March 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 19, 2014