Rectal CancerNCT00648635
Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations
An observational study of Rectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2008to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with recurrent rectal cancer.
Who may be able to join
- 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.
- Patients may have local recurrence alone, or concurrent distant metastatic disease. Patients must have recurrent rectal cancer present in the bony pelvis.
- Patients must be conversant in English in order to complete appropriate questions.
- 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.
Who cannot join
- Patients must not have non-adenocarcinoma pathology, i.e., squamous cell carcinoma of the anus, cloacogenic tumors, etc.
- Patients must not have any concurrent pelvic malignancy in addition to rectal carcinoma.
- Patients must not have ONLY distant metastases. Recurrence must be present within the bony pelvis.
- 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.
- Patient must not have had solely non-operative therapies in treatment of their primary rectal carcinoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Questionnaire
- Keywords
- Rectal Cancer, Recurrent Rectal Adenocarcinoma, Quality of Life, QOL, Questionnaire, Survey
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 30-60 minutes to complete every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| PET + QOL | Survey of how recurrent rectal cancer treatment affects well being + QOL Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QOL) Survey Responses
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.
Measured: Baseline and QOL at 6-month intervals for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study start12 Mar 2008
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George J Chang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648635
- Sponsor's protocol ID
- 2007-0322
- Other IDs
- NCI-2020-07464
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2008
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00648635
- Acronym / sponsor ID
- 2007-0322
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, Recurrent Rectal Adenocarcinoma, Quality of Life, QOL, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Mar 2008 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET + QOL | – | Behavioral: QuestionnaireSurvey of how recurrent rectal cancer treatment affects well being + QOL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with recurrent rectal cancer.
Key inclusion criteria (4 listed)
- 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.
- Patients may have local recurrence alone, or concurrent distant metastatic disease. Patients must have recurrent rectal cancer present in the bony pelvis.
- Patients must be conversant in English in order to complete appropriate questions.
- 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.
Key exclusion criteria (5 listed)
- Patients must not have non-adenocarcinoma pathology, i.e., squamous cell carcinoma of the anus, cloacogenic tumors, etc.
- Patients must not have any concurrent pelvic malignancy in addition to rectal carcinoma.
- Patients must not have ONLY distant metastases. Recurrence must be present within the bony pelvis.
- 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.
- Patient must not have had solely non-operative therapies in treatment of their primary rectal carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires taking 30-60 minutes to complete every 3 months. | Behavioural | PET + QOL |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George J Chang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QOL) Survey Responses (time frame: Baseline and QOL at 6-month intervals for 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.