Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer
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|ClinicalTrials.gov Identifier: NCT00836992|
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : May 24, 2017
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.
|Condition or disease|
|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|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||144 participants|
|Official Title:||Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy|
|Actual Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 15, 2011|
|Actual Study Completion Date :||July 27, 2015|
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.
- Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA [ Time Frame: 7 Weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836992
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|Principal Investigator:||Michele Yvette Halyard, M.D.||Mayo Clinic|