Active — Not RecruitingNot Applicable

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

United States116 participantsStarted 2008-03-12

Plain-language 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.

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Quality of Life (QOL) Survey Responses

Timeframe: Baseline and QOL at 6-month intervals for 5 years

NCT IDNCT00648635

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-30

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.