Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy

Conditions
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Anxiety, Gastric Carcinoma, Stress

Intervention / Treatment
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* Other: Educational Intervention
* Procedure: Standard Follow-Up Care
* Procedure: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be accrued using the following inclusion criteria: Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer Able to read and understand English Informal Caregivers will be accrued using the following inclusion criteria: The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery Able to read and understand English All participants must have the ability to understand the willingness to provide informed consent Exclusion Criteria: Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort I (standard care)<br>Participants receive standard post-operative care. | Procedure: Standard Follow-Up Care<br>* Receive standard post-operative care<br>Procedure: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Experimental: Cohort II (educational brochure)<br>Participants receive a 2-page educational brochure after surgery and prior to discharge home. | Other: Educational Intervention<br>* Receive educational brochure<br>* Other names: Intervention, Educational;Procedure: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver