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

Primary Purpose

Anxiety, Gastric Carcinoma, Stress

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Standard Follow-Up Care
Quality-of-Life Assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Caregiver

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cohort I (standard care)

Cohort II (educational brochure)

Arm Description

Participants receive standard post-operative care.

Participants receive a 2-page educational brochure after surgery and prior to discharge home.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in mean survey scores
Data will be summarized using descriptive statistics. Statistics will be tabulated for each sequentially enrolled cohort.

Full Information

First Posted
January 6, 2015
Last Updated
September 23, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02334332
Brief Title
Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery
Official Title
Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Gastric Carcinoma, Stress
Keywords
Caregiver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort I (standard care)
Arm Type
Active Comparator
Arm Description
Participants receive standard post-operative care.
Arm Title
Cohort II (educational brochure)
Arm Type
Experimental
Arm Description
Participants receive a 2-page educational brochure after surgery and prior to discharge home.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Receive educational brochure
Intervention Type
Procedure
Intervention Name(s)
Standard Follow-Up Care
Intervention Description
Receive standard post-operative care
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention
Description
Descriptive statistics will be presented through summary statistics of data from the satisfaction tools.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Change in mean survey scores
Description
Data will be summarized using descriptive statistics. Statistics will be tabulated for each sequentially enrolled cohort.
Time Frame
Baseline up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Sun
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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