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

City of Hope

Status: Withdrawn

Conditions: Gastric Carcinoma; Anxiety; Stress

Treatments: Other: Educational Intervention; Procedure: Quality-of-Life Assessment; Procedure: Standard Follow-Up Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02334332

14286 (Other Identifier)

NCI-2014-02563 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cohort I (standard care)

Active Comparator group

Description:

Participants receive standard post-operative care.

Treatment:

Procedure: Standard Follow-Up Care

Procedure: Quality-of-Life Assessment

Cohort II (educational brochure)

Experimental group

Description:

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

Treatment:

Procedure: Quality-of-Life Assessment

Other: Educational Intervention