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

Not Applicable

Withdrawn

• Conditions: Stress; Anxiety; Gastric Carcinoma
• Interventions: Other: Educational Intervention; Procedure: Standard Follow-Up Care; Procedure: Quality-of-Life Assessment

• Registration Number: NCT02334332
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-08
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort II (educational brochure)	Educational Intervention	Participants receive a 2-page educational brochure after surgery and prior to discharge home.
Cohort I (standard care)	Quality-of-Life Assessment	Participants receive standard post-operative care.
Cohort I (standard care)	Standard Follow-Up Care	Participants receive standard post-operative care.
Cohort II (educational brochure)	Quality-of-Life Assessment	Participants receive a 2-page educational brochure after surgery and prior to discharge home.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States