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


N/A
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Quality of Life (QoL)

Outcome Description:

Assessment of Quality of Life of Patients post standard of care radiation therapy

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Joseph Herman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J-06109

NCT ID:

NCT00414232

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Rectal Cancer
  • Chemoradiation
  • Rectal Cancer receiving chemoradiation.
  • Rectal Neoplasms

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins UniversityBaltimore, Maryland  21231