Anxiety, Gastric Carcinoma, Stress
Conditions
Keywords
Caregiver
Brief summary
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
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.
Interventions
OTHEREducational Intervention
Receive educational brochure
PROCEDUREStandard Follow-Up Care
Receive standard post-operative care
PROCEDUREQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention | Up to 2 months | Descriptive statistics will be presented through summary statistics of data from the satisfaction tools. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean survey scores | Baseline up to 4 weeks | Data will be summarized using descriptive statistics. Statistics will be tabulated for each sequentially enrolled cohort. |
Countries
United States
Outcome results
None listed