Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00414232
First received: December 20, 2006
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.


Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Quality of Life (QoL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment of Quality of Life of Patients post standard of care radiation therapy


Enrollment: 13
Study Start Date: November 2006
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

STUDY PLAN

  1. Only the principal investigator, sub-investigators, and research nurse will be approaching potential participants. The above listed also will be the only consentors for the study. The recruitment process will occur during the outpatient visits being held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health Insurance Portability and Accountability Act ) and guidelines and good clinical practice will be followed at all times to ensure that the privacy of participants included in the recruitment process are strictly guarded.
  2. Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained.
  3. The EORTC (European Organization for Research and Treatment of Cancer)QLQ- C30 (Quality of Life Questionnaire), QLQ-CR38 (Quality of Life Questionnaire), and QLQ-CR29 (Quality of Life Questionnaire) forms will be completed by patients at the following time point:

    1. Within 3 weeks prior to start of radiotherapy
    2. During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
    3. Approximately one month after completion of radiotherapy during a follow-up visit
  4. The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse or other healthcare provider will be available to help the patient with any questions regarding the QOL forms.
  5. The symptom inventory will be collected in an interview by a nurse or other healthcare provider at the following time points: d. Within 3 weeks prior to start of radiotherapy e. Once weekly during radiotherapy f. Approximately one month after completion of radiotherapy during a follow-up visit.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males or females greater than or equal to 18 years of age with a working diagnosis of rectal cancer.

Criteria

Inclusion Criteria:

  • All of the following questions must be answered "yes" for a patient to be eligible for this protocol.

    1. Is there a working diagnosis of rectal cancer? YES NO
    2. Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO
    3. Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO
    4. Is the patient ≥ 18 years of age? YES NO
    5. Can the patient give informed consent? YES NO

Exclusion Criteria:

  • All of the following questions must be answered "no" for a patient to be eligible for this protocol.

    1. Has there been prior radiation to the pelvis? YES NO
    2. Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO
  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: NCT00414232

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
University of Michigan
Investigators
Principal Investigator: Joseph Herman, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00414232     History of Changes
Other Study ID Numbers: J-06109, NA_00004324
Study First Received: December 20, 2006
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Rectal Cancer
Chemoradiation
Rectal Cancer receiving chemoradiation.

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 September 16, 2014