Clinical trial · Observational
Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations
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
NCT00648635CI-TRIAL-00121347active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET + QOL
- description
- Survey of how recurrent rectal cancer treatment affects well being + QOL
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Quality of Life (QOL) Survey Responses
- timeFrame
- Baseline and QOL at 6-month intervals for 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.