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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

— HOPE  

Official title:

HOPE Program: Quality of Life Enhancement and Survivorship Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126346
• Other study ID #: IRB00013172
• Secondary ID: NCI-2010-00980CC
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion

• Patients who undergo CS and HIPEC for peritoneal surface malignancy

Related Conditions & MeSH terms

• Advanced Malignant Mesothelioma
• Appendiceal Neoplasms
• Carcinoma of the Appendix
• Colonic Neoplasms
• Germinoma
• Lung Neoplasms
• Mesothelioma
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• 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

Behavioral:
• HIPEC Orientation
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
• 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)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Provide educational material delivered by the SRB	Form to assess utility of the Survivorship Resource Book	Pre-HIPEC to Day 0
Secondary	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