Overview

This trial is active, not recruiting.

Conditions anal cancer, colorectal cancer, esophageal cancer, extrahepatic bile duct cancer, gallbladder cancer, gastric cancer, head and neck cancer, liver cancer, lung cancer, pancreatic cancer, small intestine cancer
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date January 2009
End date September 2011
Trial size 132 participants
Trial identifier NCT00836992, 08-005566, CDR0000629594, MCS1065, P30CA015083

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patient's QOL assessments data is not shared with the physician, nurse, and/or nurse practitioner and the patient
Patient's QOL assessments data is shared with the physician, nurse, and/or nurse practitioner and the patient immediately prior to the on-treatment visit.

Primary Outcomes

Measure
Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA
time frame: 7 Weeks

Secondary Outcomes

Measure
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
time frame: 7 Weeks
Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment
time frame: 7 Weeks
Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment
time frame: 7 Weeks
Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews
time frame: One month post study
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 ...
time frame: One month post study
Average physician rating of the patient-physician relationships for the two treatment groups
time frame: 7 Weeks
Average duration of the weekly on treatment visit for the two treatment groups
time frame: 7 Weeks
Percentage of patients for which physician reports indicate that availability
time frame: 7 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy
Principal investigator Michele Yvette Halyard, M.D.
Description OBJECTIVES: - To determine if patient-reported quality of life (QOL) can be improved by the real-time use of QOL data in patients with primary lung, head and neck, or gastrointestinal cancer undergoing radiotherapy. - To obtain preliminary estimates for effect sizes on differences in key QOL domains between patients receiving real time QOL data and those not receiving QOL data. - To obtain preliminary estimates of differences in patient satisfaction between patients receiving real time QOL data and those not receiving QOL data. - To determine whether the availability of real-time QOL assessments in a radiation oncology practice increases the acceptance and utilization of QOL data by a clinical oncology team. - To evaluate clinician attitudes towards the incorporation of real-time QOL data into oncology patient management. - To evaluate the use of a set of clinical pathways for the incorporation of real time QOL data into oncology patient management. - To evaluate the potential impact on the quality of the patient-physician relationship with real-time use of QOL data compared to interactions where quality of life data are not utilized. - To obtain preliminary estimates of whether the real-time use of QOL data in a radiation oncology practice significantly increases the duration of the weekly on treatment visit. OUTLINE: Patients are randomized to 1 of 2 groups. - Group 1 (control): Patients complete QOL assessments (e.g., the Linear Analog Self Assessment [LASA]) at weeks 1, 3, and 5 during treatment and the last week of treatment. They also complete the Interpersonal Patient-Provider Relationship Scale (IPPRS) and Was it Worth It (WIW) questionnaires on the final day of treatment. Data is not shared with the physician, the patient, or any other clinical assistant that may be supporting the physician (e.g. nurse, or nurse practitioner). - Group 2 (active): Patients complete QOL assessments (e.g., LASA) and the IPPRS and WIW questionnaires as in group 1. Information from the questionnaires is shared with the physician, nurse, and/or nurse practitioner and the patient immediately prior to the on-treatment visit.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.