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Clinical Trials/NCT01126346
NCT01126346
Completed
Not Applicable

HOPE Program: Quality of Life Enhancement and Survivorship Care

Wake Forest University Health Sciences1 site in 1 country10 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Malignant Mesothelioma
Sponsor
Wake Forest University Health Sciences
Enrollment
10
Locations
1
Primary Endpoint
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
October 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Provide educational material delivered by the SRB(Pre-HIPEC to Day 0)
  • Improve overall post-operative QOL ratings at 3 months, relative to discharge(3 months post discharge)
  • Reduce pre-treatment distress and anxiety(Pre-HIPEC to Day 0)
  • Improve pre-treatment self-efficacy(Pre-HIPEC to Day 0)

Study Sites (1)

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