Colorectal Cancer Clinical Trial
Official title:
Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy
Verified date | May 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
RATIONALE: Gathering information about patients' quality of life during radiation therapy
for cancer may help doctors plan the best treatment.
PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing
radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.
Status | Completed |
Enrollment | 144 |
Est. completion date | July 27, 2015 |
Est. primary completion date | September 15, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Primary lung cancer - Head and neck cancer - Gastrointestinal cancer - No evidence of distant metastasis - Receiving = 5 weeks of definitive or adjuvant radiotherapy at Mayo Clinic Arizona PATIENT CHARACTERISTICS: - Able to complete computer based questionnaires - Able to complete quality of life questionnaires in English - Willing and able to comprehend and provide informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA | 7 Weeks | ||
Secondary | Component QOL domains reported on the five numerical analogue items (physical, intellectual, emotional, spiritual, and social QOL), average pain item and fatigue reported in the LASA | 7 Weeks | ||
Secondary | Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment | 7 Weeks | ||
Secondary | Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment | 7 Weeks | ||
Secondary | Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews | One month post study | ||
Secondary | Proportion of cases for which the clinical team indicates that the clinical pathways contributed positively to patient management, the number of cases which the clinicians report referrals were generated, and the qualitative data derived from the pos ... | One month post study | ||
Secondary | Average physician rating of the patient-physician relationships for the two treatment groups | 7 Weeks | ||
Secondary | Average duration of the weekly on treatment visit for the two treatment groups | 7 Weeks | ||
Secondary | Percentage of patients for which physician reports indicate that availability | 7 Weeks |
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