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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.
PRIMARY OBJECTIVE:
I. To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.
SECONDARY OBJECTIVE:
II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive printed materials describing the technical aspects of their treatment.
ARM II: Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (printed materials) | Active Comparator | Patients receive printed materials describing the technical aspects of their treatment. |
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| Arm II (printed materials, physicist interaction) | Experimental | Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive printed materials |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups. | 4 months |
| Distress | Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient treatment adherence | Will be assessed using 2-sided unpaired t-test. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Burmeister, PhD | Barbara Ann Karmanos Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling | Other | Receive direct physicist interactions to describe the technical aspects of the treatment |
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| Questionnaire Administration | Other | Ancillary studies |
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| D005159 | Health Care Facilities Workforce and Services |