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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01126346

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: HIPEC Orientation Behavioral: Consultation with Survivorship Navigator Other: Questionnaires	N/A

Detailed Description

PRIMARY OBJECTIVES:

Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population.

SECONDARY OBJECTIVES:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

HOPE Program: Quality of Life Enhancement and Survivorship Care

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I 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 Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session Other Names: orientation 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 Names: Consultation 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)

Arm

Intervention/Treatment

Experimental: Arm I

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

Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session

Other Names:

orientation

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 Names:

Consultation

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)

Outcome Measures

Primary Outcome Measures

Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population [Baseline to 3 months post discharge]
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)

Secondary Outcome Measures

Reduce pre-treatment distress and anxiety [Pre-HIPEC to Day 0]
Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
Improve pre-treatment self-efficacy [Pre-HIPEC to Day 0]
Mean scores on the distress thermometer will be compared as well as individual patient changes.
Provide educational material delivered by the SRB [Pre-HIPEC to Day 0]
Form to assess utility of the Survivorship Resource Book
Improve overall post-operative QOL ratings at 3 months, relative to discharge [3 months post 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.