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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01259 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| OS-15-15 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies how well ringing a bell on the final day of radiation therapy works in improving the memory of distress in cancer patients. Ringing a bell on the final day of radiation therapy may improve the memory of how painful the treatment was.
PRIMARY OBJECTIVES:
I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.
SECONDARY OBJECTIVES:
I. To measure the severity of patients' memory of distress from cancer treatment.
II. To assess the relationship between anxiety to actual distress and to remembered distress.
III. To assess the relationship between optimism-pessimism personality to actual distress and to remembered distress.
IV. To assess patient's cognitive dissonance reduction to actual distress and to remembered distress.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A (No bell ringing): Patients undergo standard of care radiation therapy with or without chemotherapy.
GROUP B (Bell ringing): On the final day of standard of care radiation therapy, patients ring a bell in the clinic.
After completion of study, patients are followed up for 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (no bell after final radiation) | Active Comparator | Patients undergo standard of care radiation therapy with or without chemotherapy. |
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| Group B (ring bell after final radiation treatment) | Experimental | On the final day of standard of care radiation therapy, patients ring a bell in the clinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memory Intervention | Other | Ring bell after final radiation treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Distress memory scales as assessed by the 11-point Numeric Rating Scale | Patient baseline characteristics and treatment will be summarized in groups A and B. Repeated measures analysis of variance (ANOVA) will be used to compare distress memory scales between patients in group A and group B. A mixed regression model will be used to examine the effect of ringing the bell on the last day of radiotherapy on distress memory scales when considering covariates such as baseline patient characteristics, cancer type, radiotherapy total dose and duration, baseline distress scale, analgesic medication, disease recurrence status, optimism/pessimism personality and anxiety. | Up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level as assessed by Generalized Anxiety Disorder 7 scale | Repeated measures ANOVA will be used to compare anxiety levels between patients in group A and group B. All p values will be two-sided at a significance level of 0.05. | Up to 7 months |
| Optimism-pessimism scores as assessed by the Life Orientation Test-Revised |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Williams | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Questionnaire Administration | Other | Ancillary studies |
|
Repeated measures ANOVA will be used to compare optimisim-pessimism scores between patients in group A and group B. All p values will be two-sided at a significance level of 0.05. |
| Up to 7 months |