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

February 17, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with recurrent rectal cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QOL) Survey Responses
Time Frame: Baseline and QOL at 6-month intervals for 5 years
Primary endpoint of QOL assessed using EORTC QLQ-CR29 survey form. Change of QOL defined as the difference between the baseline and the QOL at 6-month intervals.
Baseline and QOL at 6-month intervals for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: George J Chang, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2008

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimated)

April 1, 2008

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0322
  • NCI-2020-07464 (Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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