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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02334332
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location
2
Arms
8
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Procedure: Standard Follow-Up Care
  • Procedure: Quality-of-Life Assessment
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cohort I (standard care)

Participants receive standard post-operative care.

Procedure: Standard Follow-Up Care
Receive standard post-operative care

Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    		•
    Experimental: Cohort II (educational brochure)

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

    Other: Educational Intervention
    Receive educational brochure
    Other Names:
  • Education for Intervention
  • Intervention, Educational

    • Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Virginia Sun, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT02334332
    Other Study ID Numbers:
    • 14286
    • NCI-2014-02563
    • 14286
    First Posted:
    Jan 8, 2015
    Last Update Posted:
    Sep 25, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by City of Hope Medical Center
    Caregiver
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Sep 25, 2015