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

Not Applicable

Completed

• Conditions: Advanced Malignant Mesothelioma; Carcinoma of the Appendix; Stage III Ovarian Germ Cell Tumor; Ovarian Sarcoma; Recurrent Malignant Mesothelioma; Stage IV Colon Cancer; Pseudomyxoma Peritonei; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Stage IV Ovarian Epithelial Cancer
• Interventions: Behavioral: HIPEC Orientation; Behavioral: Consultation with Survivorship Navigator; Other: Questionnaires

• Registration Number: NCT01126346
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2011-04
• Study Completion: 2013-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Consultation with Survivorship Navigator	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.
Arm I	HIPEC Orientation	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.
Arm I	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population	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 Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States