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

Wake Forest University (WFU)

Status: Completed

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

Treatments: Behavioral: Consultation with Survivorship Navigator; Other: Questionnaires; Behavioral: HIPEC Orientation

Study type: Interventional

Funder types: Other

Identifiers

NCT01126346

NCI-2010-00980

IRB00013172

CCCWFU 97110 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Patients who undergo CS and HIPEC for peritoneal surface malignancy

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Behavioral: HIPEC Orientation

Other: Questionnaires

Behavioral: Consultation with Survivorship Navigator