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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02334332
• Other study ID #: 14286
• Secondary ID: NCI-2014-0256314
• Status: Withdrawn
• Phase: N/A
• First received: January 6, 2015
• Last updated: September 23, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Gastric Carcinoma
• Stomach Neoplasms
• Stress

Intervention

Other:
• Educational Intervention
Receive educational brochure

Procedure:
• Standard Follow-Up Care
Receive standard post-operative care
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No