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

NCT00648635 | Active Not Recruiting

• 2 other identifiers: 2007-0322NCI-2020-07464
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Recurrent Rectal Adenocarcinoma; Quality of Life; QOL; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and QOL at 6-month intervals for 5 years

Study Arms (1)

PET + QOL

Survey of how recurrent rectal cancer treatment affects well being + QOL

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaires taking 30-60 minutes to complete every 3 months.

Also known as: Survey

PET + QOL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent rectal cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• George J Chang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: March 12, 2008
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)