NCT01126346

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

HOPE Program: Quality of Life Enhancement and Survivorship Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
BEHAVIORAL	HIPEC Orientation	Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
BEHAVIORAL	Consultation with Survivorship Navigator	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	Questionnaires	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)

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-04-01
• Completion: 2013-10-01
• First posted: 2010-05-19
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States