Clinical Trial: Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: HOPE Program: Quality of Life Enhancement and Survivorship 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 Summary:
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.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome: Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population [ Time Frame: Baseline to 3 months post discharge ]
Original Primary Outcome:
- Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population [ Time Frame: T1, Baseline/pre-HIPEC orientation, Day 0 ]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)
- Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population [ Time Frame: T2, after HIPEC orientation, Day 0 ]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)
- Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population [ Time Frame: T3, 1 month post HIPEC, Average Day 30 ]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)
- Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population [ Time Frame: T4, 3 months post HIPEC, Average Day 90 ]Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Dep
Current Secondary Outcome:
- Reduce pre-treatment distress and anxiety [ Time Frame: Pre-HIPEC to Day 0 ]Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
- Improve pre-treatment self-efficacy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome:
- Reduce pre-treatment distress and anxiety [ Time Frame: Pre-HIPEC, Day 0 ]Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
- Improve pre-treatment self-efficacy [ Time Frame: Pre-HIPEC, Day 0 ]Mean scores on the distress thermometer will be compared as well as individual patient changes.
- Provide educational material delivered by the SRB [ Time Frame: Pre-HIPEC, Day 0 ]Form to assess utility of the Survivorship Resource Book
- 4) Improve overall post-operative QOL ratings at 3 months, relative to discharge [ Time Frame: T4, 3 months post discharge, Average Day 90 ]Improve post-operative QOL ratings at 3 months, relative to discharge. Repeated measures analysis of covariance (ANCOVA) will be utilized with the FACT scales.
Information By: Wake Forest University Health Sciences
Dates:
Date Received: May 13, 2010
Date Started: May 2010
Date Completion:
Last Updated: January 17, 2017
Last Verified: July 2014
- Reduce pre-treatment distress and anxiety [ Time Frame: Pre-HIPEC to Day 0 ]