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

Study Overview
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Brief Summary
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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
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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.

Official Title
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HOPE Program: Quality of Life Enhancement and Survivorship Care

Conditions
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Advanced Malignant Mesothelioma, Carcinoma of the Appendix, Ovarian Sarcoma, Ovarian Stromal Cancer, Pseudomyxoma Peritonei, Recurrent Colon Cancer, Recurrent Malignant Mesothelioma, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Stage III Colon Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage IV Colon Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: HIPEC Orientation
* Behavioral: Consultation with Survivorship Navigator
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Patients who undergo CS and HIPEC for peritoneal surface malignancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Behavioral: HIPEC Orientation<br>* Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session<br>* Other names: orientation;Behavioral: Consultation with Survivorship Navigator<br>* 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<br>* Other names: Consultation;Other: Questionnaires<br>* 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)<br>|

What is the study measuring?
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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 | 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 | Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale). | Pre-HIPEC to Day 0 | 
| Improve pre-treatment self-efficacy | 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 | 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 | 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 |