Breast CancerNCT00595218
Patient Preference Survey for Radiation Oncologists
A study testing Physician behavior related to Patient Preference Survey and Patient Preference Results in people with Breast Cancer and Prostate Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- Physician behavior related to Patient Preference Survey and Patient Preference Results
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient/subject under age 18 If subject previously underwent this study, even if the previous study was for a different diagnosis. Subjects can only undergo this study once.
- Patients/subjects who do not have the functional and mental capacity to independently answer the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- How should the radiation oncologist address them (by their first name or Mr/Mrs)?
- Should the radiation oncologists wear a white coat?
- Should the radiation oncologist discuss their prognosis and survival with them?
- Should the radiation oncologist have physical contact with their patient (hold hand or hug the patient.)?
- Should the radiation oncologist inquire about their religious beliefs to help cope with their cancer?
- 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.
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer
- Being tested
- Physician behavior related to Patient Preference Survey, Patient Preference Results
- Keywords
- Patient Preferences, Patient Satisfaction, Patient-Doctor Relationship
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Patient Preference, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician behavior related to Patient Preference SurveyBehavioural
Access to initial Patient preference survey results
Patient Preference ResultsOther
Knowledge of Patient Preference Results
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Patients whose radiation oncologist are blinded to their patient preference survey results |
| 2 | Active comparator | Patients whose radiation oncologist are not blinded to their patient preference survey results Receives: Behavioral: Physician behavior related to Patient Preference Survey; Other: Patient Preference Results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Did knowledge of patient preference improve patient satisfaction
Measured: Length of radiation treatment
Secondary outcomes (1)
Patient preferences regarding their radiation oncologists
Measured: Length of radiation treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dwight Heron, University of Pittsburgh
- Investigators
- Ajay Bhatnagar, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595218
- Sponsor's protocol ID
- PittRadOnc
- Other IDs
- ASTRO grant
- Status last verified
- Jul 2017
- First submitted
- 4 Jan 2008
- Last updated
- 25 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00595218
- Acronym / sponsor ID
- PittRadOnc
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer
- Keywords
- Patient Preferences, Patient Satisfaction, Patient-Doctor Relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- How should the radiation oncologist address them (by their first name or Mr/Mrs)?
- Should the radiation oncologists wear a white coat?
- Should the radiation oncologist discuss their prognosis and survival with them?
- Should the radiation oncologist have physical contact with their patient (hold hand or hug the patient.)?
- Should the radiation oncologist inquire about their religious beliefs to help cope with their cancer?
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Patients whose radiation oncologist are blinded to their patient preference survey results |
| 2 | Active comparator | Behavioral: Physician behavior related to Patient Preference Survey, Other: Patient Preference ResultsPatients whose radiation oncologist are not blinded to their patient preference survey results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patient/subject under age 18 If subject previously underwent this study, even if the previous study was for a different diagnosis. Subjects can only undergo this study once.
- Patients/subjects who do not have the functional and mental capacity to independently answer the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician behavior related to Patient Preference SurveyAccess to initial Patient preference survey results | Behavioural | 2 |
| Patient Preference ResultsKnowledge of Patient Preference Results | Other | 2 |
Primary outcome
Did knowledge of patient preference improve patient satisfaction
Time frame: Length of radiation treatment
1 secondary outcome
Patient preferences regarding their radiation oncologists
Time frame: Length of radiation treatment course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Bhatnagar, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician behavior related to Patient Preference Survey and Patient Preference Results in people with Breast Cancer and Prostate Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Did knowledge of patient preference improve patient satisfaction (time frame: Length of radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.