Clinical trial NCT01126346: Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Official title: HOPE Program: Quality of Life Enhancement and Survivorship Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion

* Patients who undergo CS and HIPEC for peritoneal surface malignancy

Primary outcomes:
measure: Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population
timeFrame: Baseline to 3 months post discharge
Secondary outcomes:
measure: Reduce pre-treatment distress and anxiety
timeFrame: Pre-HIPEC to Day 0
measure: Improve pre-treatment self-efficacy
timeFrame: Pre-HIPEC to Day 0
measure: Provide educational material delivered by the SRB
timeFrame: Pre-HIPEC to Day 0
measure: Improve overall post-operative QOL ratings at 3 months, relative to discharge
timeFrame: 3 months post discharge
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Richard McQuellon
role: PRINCIPAL_INVESTIGATOR
References: