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2009-01
2011-09-15
2015-07-27
144
NCT00836992
Mayo Clinic
Mayo Clinic
OBSERVATIONAL
Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-02-03 | N/A | 2017-05-23 |
2009-02-03 | N/A | 2017-05-24 |
2009-02-04 | N/A | 2017-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Control Patient's QOL assessments data is not shared with the physician, nurse, and/or nurse practitioner and the patient | |
| : Active 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA | 7 Weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | |
| Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment | 7 Weeks | |
| Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment | 7 Weeks | |
| Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews | 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 ... | One month post study | |
| Average physician rating of the patient-physician relationships for the two treatment groups | 7 Weeks | |
| Average duration of the weekly on treatment visit for the two treatment groups | 7 Weeks | |
| Percentage of patients for which physician reports indicate that availability | 7 Weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
