Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00648635
First received: March 27, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The goal of this study is to learn how the treatment given to patients with recurrent rectal cancer affects their well being and quality of life.


Condition Intervention
Rectal Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study for Prospective Discovery of Possible Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations in Patients Undergoing Treatment for Locally Recurrent Rectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Quality of Life (QOL) Survey Responses [ Time Frame: Baseline and QOL at 6-month intervals for 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PET + QOL
Survey of how recurrent rectal cancer treatment affects well being + QOL
Behavioral: Questionnaire
Questionnaires taking 30-60 minutes to complete every 3 months.
Other Name: Survey

Detailed Description:

If you agree to take part in this study, you will complete 4 questionnaires at each of your regularly scheduled doctor's visits (about every 6 months). Someone will help you to go through the questionnaires when you are given your first packet. If you are unable to complete the questionnaires while at your study visit, you may choose to take some or all of the questionnaires home. If you take the questionnaires home, you will be given a self-addressed stamped envelope so that you can return them to the study coordinator. If you choose, you may also complete the questionnaires over the phone.

The questionnaires will ask you about how you feel about the cancer treatment, how treatment for rectal cancer has affected your health and lifestyle, what you expect during and after your treatment, and about any pain you are experiencing and if the pain management is working for you. It should take about 30-60 minutes to complete the questionnaires each time.

If you will not be in the clinic for more than 6 months, the questionnaires will be mailed to you. You will return them in a self-addressed stamped envelope. If you have not completed the questionnaires within 2 weeks of receiving them, a research staff member will call you to remind you to complete the questionnaires, and to assist you with completing them (if necessary). If you have not completed the questionnaires by the time you come for your next follow-up visit, a research staff member will assist you with completing them at your visit (if necessary).

If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive mental health screening.

At each of your appointments or between your appointments (if needed) researchers will collect study related information for your medical record.

Researchers will also review the images of the positron emission tomography (PET) scans or other diagnostic tests that you take as part of your standard of care. By viewing PET scan images or diagnostic tests, researchers hope to be able to discover whether there is any connection between the images on the PET scan or diagnostic tests and the symptoms that you are having. The PET scan or other diagnostic tests is are part of your standard treatment for your recurrent rectal cancer, and you will not have to have any special tests or scans just to participate in this study.

The data researchers collect will also be used to form a database of patients with recurrent rectal cancer. The database will be located on a password protected Surgical Oncology computer and it will be available only to the study doctor and the research staff that need to complete the study. The database will include information about each participant on the study. It will include information about the participant's name, medical record number, age, gender, diagnosis, the study questionnaires, and information about the disease.

Length of Study:

You will remain on study for up to 5 years.

This is an investigational study.

Up to 164 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with recurrent rectal cancer.

Criteria

Inclusion Criteria:

  1. All patients who have had previous surgical treatment of rectal adenocarcinoma, regardless of age, with locally recurrent (pelvic) rectal adenocarcinoma are eligible, if a period of at least 3 months exists between initial treatment and disease recurrence.
  2. Patients may have local recurrence alone, or concurrent distant metastatic disease. Patients must have recurrent rectal cancer present in the bony pelvis.
  3. Patients must be conversant in English in order to complete appropriate questions.
  4. Patients must understand the test and questionnaire parameters, including the need for PET testing to assess the correlation between perceived symptoms and PET or other diagnostic results. Patients must be able and willing to complete all scheduled appointments and complete and return all study questionnaires.

Exclusion Criteria:

  1. Patients must not have non-adenocarcinoma pathology, i.e., squamous cell carcinoma of the anus, cloacogenic tumors, etc.
  2. Patients must not have any concurrent pelvic malignancy in addition to rectal carcinoma.
  3. Patients must not have ONLY distant metastases. Recurrence must be present within the bony pelvis.
  4. Patients must not have a history of either a documented pelvic pain syndrome or a preoperative documented diagnosis of chronic constipation (defined as < 1 BM per 48 hours, unrelated to rectal cancer or mechanical obstruction) preceding the cancer diagnosis.
  5. Patient must not have had solely non-operative therapies in treatment of their primary rectal carcinoma.
  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: NCT00648635

Contacts
Contact: John Skibber, MD 713-792-6940

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: John Skibber, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: John Skibber, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00648635     History of Changes
Other Study ID Numbers: 2007-0322
Study First Received: March 27, 2008
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Rectal Cancer
Recurrent Rectal Adenocarcinoma
Quality of Life
QOL
Questionnaire
Survey

ClinicalTrials.gov processed this record on September 16, 2014