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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02563 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14286 | Other Identifier | City of Hope Medical Center |
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No accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.
PRIMARY OBJECTIVES:
I. To pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy.
SECONDARY OBJECTIVES:
I. To describe preliminary effect of the intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.
OUTLINE: Participants are enrolled sequentially to 1 of 2 cohorts.
COHORT I: Participants receive standard post-operative care.
COHORT II: Participants receive a 2-page educational brochure after surgery and prior to discharge home.
After completion of study, participants are followed up for approximately 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I (standard care) | Active Comparator | Participants receive standard post-operative care. |
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| Cohort II (educational brochure) | Experimental | Participants receive a 2-page educational brochure after surgery and prior to discharge home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive educational brochure |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention | Descriptive statistics will be presented through summary statistics of data from the satisfaction tools. | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean survey scores | Data will be summarized using descriptive statistics. Statistics will be tabulated for each sequentially enrolled cohort. | Baseline up to 4 weeks |
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Inclusion Criteria:
Patients will be accrued using the following inclusion criteria:
Informal Caregivers will be accrued using the following inclusion criteria:
All participants must have the ability to understand the willingness to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Standard Follow-Up Care | Procedure | Receive standard post-operative care |
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| Quality-of-Life Assessment | Procedure | Ancillary studies |
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|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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