Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (HOPE)

HOPE Program: Quality of Life Enhancement and Survivorship Care

RATIONALE: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies.

PURPOSE: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface malignancies.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population.

SECONDARY OBJECTIVES:

I. Reduce pre-treatment distress and anxiety. II. Improve pre-treatment self-efficacy. III. Provide educational material delivered by the SRB. IV. Improve overall post-operative QOL ratings at 3 months, relative to discharge.

OUTLINE:

Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. . After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks, and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion

  • Patients who undergo CS and HIPEC for peritoneal surface malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month.
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
Other Names:
  • orientation
Weekly psychosocial support via phone from Survivorship Navigator for 3 weeks prior to HIPEC; Inpatient consults occurring 3 to 4 days post-HIPEC and biweekly for 2 weeks and weekly until hospital discharge; Post-Hospital Discharge consults via phone twice per month for one month
Other Names:
  • Consultation
Questionnaires Completed at 4 time points: T1 pre-HIPEC orientation, T2 with in 1 week of orientation, T3 1 month post HIPEC and T4 3 months post HIPEC. Questionnaires include Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population
Time Frame: Baseline to 3 months post discharge
Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)
Baseline to 3 months post discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce pre-treatment distress and anxiety
Time Frame: Pre-HIPEC to Day 0
Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
Pre-HIPEC to Day 0
Improve pre-treatment self-efficacy
Time Frame: Pre-HIPEC to Day 0
Mean scores on the distress thermometer will be compared as well as individual patient changes.
Pre-HIPEC to Day 0
Provide educational material delivered by the SRB
Time Frame: Pre-HIPEC to Day 0
Form to assess utility of the Survivorship Resource Book
Pre-HIPEC to Day 0
Improve overall post-operative QOL ratings at 3 months, relative to discharge
Time Frame: 3 months post discharge
Improve post-operative QOL ratings at 3 months, relative to discharge. Repeated measures analysis of covariance (ANCOVA) will be utilized with the FACT scales.
3 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard McQuellon, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (ESTIMATE)

May 19, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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