Rectal AdenocarcinomaNCT02107105
Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
An observational study of Rectal Adenocarcinoma and Stage I Rectal Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma, Stage I Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8
- What is being tested?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2014to 31 May 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with stave I-IV rectal adenocarcinoma at the Colorectal Clinic at M D Anderson Cancer Center
Who may be able to join
- Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
- Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English
Who cannot join
- Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
- Patient has a concurrent cancer diagnosis at the time of consent
- Patient has recurrent disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
George J. Chang, 713-792-6940
George J. Chang
About this study
Official title: Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.
SECONDARY OBJECTIVES:
- To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.
II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.
III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.
IV. To identify gaps in preoperative counseling for pelvic exenteration by eliciting in-depth insights into patient values, expectations, and lived experiences through qualitative interviews with patients who have undergone surgery for locally advanced or recurrent rectal cancer.
- To identify themes, communication strategies, and informational content used during preoperative counseling for pelvic exenteration through qualitative interviews with providers.
OUTLINE:
Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.
- Conditions
- Rectal Adenocarcinoma, Stage I Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life questionnaire
Questionnaire AdministrationOther
Complete quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire) | Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health state utilities
A health state utility is the degree of preference that individuals or society has for a particular health state or condition.
Measured: At 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start16 May 2014
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George J Chang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107105
- Sponsor's protocol ID
- 2013-0631
- Other IDs
- NCI-2020-07835, 2013-0631, K07CA133187
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2014
- Last updated
- 31 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT02107105
- Acronym / sponsor ID
- 2013-0631
- Conditions
- Rectal Adenocarcinoma, Stage I Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 May 2014 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 8 Apr 2014 (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.
This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.
Detailed description
PRIMARY OBJECTIVE:
- To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.
SECONDARY OBJECTIVES:
- To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.
II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.
III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.
IV. To identify gaps in preoperative counseling for pelvic exenteration by eliciting in-depth insights into patient values, expectations, and lived experiences through qualitative interviews with patients who have undergone surgery for locally advanced or recurrent rectal cancer.
- To identify themes, communication strategies, and informational content used during preoperative counseling for pelvic exenteration through qualitative interviews with providers.
OUTLINE:
Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with stave I-IV rectal adenocarcinoma at the Colorectal Clinic at M D Anderson Cancer Center
Key inclusion criteria (2 listed)
- Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
- Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English
Key exclusion criteria (3 listed)
- Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
- Patient has a concurrent cancer diagnosis at the time of consent
- Patient has recurrent disease
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life questionnaire | Other | Observational (questionnaire) |
| Questionnaire AdministrationComplete quality of life questionnaire | Other | Observational (questionnaire) |
Primary outcome
Health state utilities
Time frame: At 24 months post-surgery
A health state utility is the degree of preference that individuals or society has for a particular health state or condition.
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 31 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
George J Chang 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 Adenocarcinoma and Stage I Rectal Cancer AJCC v8, 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 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?
Contact George Chang (713-792-6940, GChang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health state utilities (time frame: At 24 months post-surgery). 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 31 Aug 2026.