Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (HOPE)
Primary Purpose
Advanced Malignant Mesothelioma, Carcinoma of the Appendix, Ovarian Sarcoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIPEC Orientation
Consultation with Survivorship Navigator
Questionnaires
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Malignant Mesothelioma
Eligibility Criteria
Inclusion
- Patients who undergo CS and HIPEC for peritoneal surface malignancy
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm I
Arm 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Reduce pre-treatment distress and anxiety
Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
Improve pre-treatment self-efficacy
Mean scores on the distress thermometer will be compared as well as individual patient changes.
Provide educational material delivered by the SRB
Form to assess utility of the Survivorship Resource Book
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.
Full Information
NCT ID
NCT01126346
First Posted
May 13, 2010
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01126346
Brief Title
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Acronym
HOPE
Official Title
HOPE Program: Quality of Life Enhancement and Survivorship Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
HIPEC Orientation
Other Intervention Name(s)
orientation
Intervention Description
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
Intervention Type
Behavioral
Intervention Name(s)
Consultation with Survivorship Navigator
Other Intervention Name(s)
Consultation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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)
Primary Outcome Measure Information:
Title
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population
Description
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)
Time Frame
Baseline to 3 months post discharge
Secondary Outcome Measure Information:
Title
Reduce pre-treatment distress and anxiety
Description
Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
Time Frame
Pre-HIPEC to Day 0
Title
Improve pre-treatment self-efficacy
Description
Mean scores on the distress thermometer will be compared as well as individual patient changes.
Time Frame
Pre-HIPEC to Day 0
Title
Provide educational material delivered by the SRB
Description
Form to assess utility of the Survivorship Resource Book
Time Frame
Pre-HIPEC to Day 0
Title
Improve overall post-operative QOL ratings at 3 months, relative to discharge
Description
Improve post-operative QOL ratings at 3 months, relative to discharge. Repeated measures analysis of covariance (ANCOVA) will be utilized with the FACT scales.
Time Frame
3 months post discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Patients who undergo CS and HIPEC for peritoneal surface malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard McQuellon
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
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