Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-07 @ 1:46 PM
Study NCT ID:
NCT00595218
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2008-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preference Survey for Radiation Oncologists
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
How Can Radiation Oncologists Better Serve Their Patients? A Randomized Study to Determine Whether Radiation Oncologists Can Improve Patient Satisfaction by Attempting to Meet Their Patients' Preferences
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Limited data exists for the cancer patients' preferences on their patient-doctor interaction with their radiation oncologist. These physicians have the opportunity to develop intimate relationships with their patients since these patients typically require daily radiation treatments anywhere from one to seven weeks. Thus, by having a greater understanding of the individual patient preferences, the radiation oncologists will be able to better serve their patients leading to improved patient satisfaction with their physician and healthier outlook on life. This is the premise and the hypothesis of this study.
Detailed Description:
An instrument, a questionnaire, previously developed by our group (IRB# 0512075) will be used to determine these cancer patient/subjects' preferences for the following six categories (see Appendix 1)
1. How should the radiation oncologist address them (by their first name or Mr/Mrs)?
2. Should the radiation oncologists wear a white coat?
3. Should the radiation oncologist discuss their prognosis and survival with them?
4. Should the radiation oncologist have physical contact with their patient (hold hand or hug the patient.)?
5. Should the radiation oncologist inquire about their religious beliefs to help cope with their cancer?
6. Should the radiation oncologist use basic, lay language or more technical terminology when describing the radiation treatment?
This research study will consist of a randomized study of breast, prostate, and lung cancer patients/subjects receiving radiation therapy at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers who will complete this questionnaire. Radiation therapy can be either for definitive or palliative therapy. This creates six distinct cohorts in the study (definitive breast, prostate, and lung cancer, palliative breast, prostate, and lung cancer) that provide an adequate representation of the cancer patient/subject cohorts that receive radiation therapy.
Patients/subjects will answer this questionnaire at the time of the initial consultation with the radiation oncologist (before meeting the radiation oncologist), once midway during radiation therapy, and at the completion of the radiation treatment. At completion, there will be additional questions used from a modified version of an established validated instrument currently being used at the University of Pittsburgh Cancer Institute to assess patient/subject satisfaction. (Appendix 2). Participants will rate the importance of each item on a 5-point scale: strongly disagree, disagree, neither agree nor disagree, agree, or strongly agree. They will also use a parallel ranking from 0-100 on each item to more finely assess the satisfaction differences for the survey in Appendix 2 only.
After subjects answer the questionnaire at time of initial consultation, the subject will then be randomized to either an experimental or control group. In the experimental group, the radiation oncologist participants will read their patient's responses to this questionnaire prior to their initial consultation and try to adapt to the subject's (patient's) preferences. In the control group, the radiation oncologist participant will be blinded to the results of their patient's questionnaire. At the end of treatment, the radiation oncologists who viewed their patient preferences will have to answer the following question according to the 5 point scale system: "Did knowledge of your patient's preferences influence your behavior?" The radiation oncologist participant will not have access to the patient satisfaction survey.
The duration of study per patient participant will the duration of the radiation treatment which has an average length of 4 weeks. A subject accrual of 500 patient participants and 30 radiation oncologist participants is expected at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers, consisting of 19 Radiation Oncology centers across Western Pennsylvania. The expected duration of the entire study is 1 year. The data will be collected through these instruments to generate a database collected in our database management system. The data will be coded and maintained by the clinical study coordinator.
1. How should the radiation oncologist address them (by their first name or Mr/Mrs)?
2. Should the radiation oncologists wear a white coat?
3. Should the radiation oncologist discuss their prognosis and survival with them?
4. Should the radiation oncologist have physical contact with their patient (hold hand or hug the patient.)?
5. Should the radiation oncologist inquire about their religious beliefs to help cope with their cancer?
6. Should the radiation oncologist use basic, lay language or more technical terminology when describing the radiation treatment?
This research study will consist of a randomized study of breast, prostate, and lung cancer patients/subjects receiving radiation therapy at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers who will complete this questionnaire. Radiation therapy can be either for definitive or palliative therapy. This creates six distinct cohorts in the study (definitive breast, prostate, and lung cancer, palliative breast, prostate, and lung cancer) that provide an adequate representation of the cancer patient/subject cohorts that receive radiation therapy.
Patients/subjects will answer this questionnaire at the time of the initial consultation with the radiation oncologist (before meeting the radiation oncologist), once midway during radiation therapy, and at the completion of the radiation treatment. At completion, there will be additional questions used from a modified version of an established validated instrument currently being used at the University of Pittsburgh Cancer Institute to assess patient/subject satisfaction. (Appendix 2). Participants will rate the importance of each item on a 5-point scale: strongly disagree, disagree, neither agree nor disagree, agree, or strongly agree. They will also use a parallel ranking from 0-100 on each item to more finely assess the satisfaction differences for the survey in Appendix 2 only.
After subjects answer the questionnaire at time of initial consultation, the subject will then be randomized to either an experimental or control group. In the experimental group, the radiation oncologist participants will read their patient's responses to this questionnaire prior to their initial consultation and try to adapt to the subject's (patient's) preferences. In the control group, the radiation oncologist participant will be blinded to the results of their patient's questionnaire. At the end of treatment, the radiation oncologists who viewed their patient preferences will have to answer the following question according to the 5 point scale system: "Did knowledge of your patient's preferences influence your behavior?" The radiation oncologist participant will not have access to the patient satisfaction survey.
The duration of study per patient participant will the duration of the radiation treatment which has an average length of 4 weeks. A subject accrual of 500 patient participants and 30 radiation oncologist participants is expected at the University of Pittsburgh Cancer Institute and UPMC Cancer Centers, consisting of 19 Radiation Oncology centers across Western Pennsylvania. The expected duration of the entire study is 1 year. The data will be collected through these instruments to generate a database collected in our database management system. The data will be coded and maintained by the clinical study coordinator.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ASTRO grant | None | None | View |