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

NCT ID: NCT02334332

Last Updated: 2015-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Anxiety Gastric Carcinoma Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cohort I (standard care)

Participants receive standard post-operative care.

Group Type ACTIVE_COMPARATOR

Standard Follow-Up Care

Intervention Type PROCEDURE

Receive standard post-operative care

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Cohort II (educational brochure)

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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive educational brochure

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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Educational Intervention

Receive educational brochure

Intervention Type OTHER

Standard Follow-Up Care

Receive standard post-operative care

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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Education for Intervention Intervention, Educational Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer
* Able to read and understand English

* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia Sun

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2014-02563

Identifier Type: REGISTRY

Identifier Source: secondary_id

14286

Identifier Type: OTHER

Identifier Source: secondary_id

14286

Identifier Type: -

Identifier Source: org_study_id

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