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 ]

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)


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