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

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.

Tracking Information
First Received DateMay 13, 2010
Last Changed DateMay 25, 2017
Start DateMay 2010
Actual Primary Completion DateApril 2011
Primary Outcome Measures

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]

Secondary Outcome Measures

Reduce pre-treatment distress and anxiety [Time Frame: Pre-HIPEC to Day 0]

Improve pre-treatment self-efficacy [Time Frame: Pre-HIPEC to Day 0]

Provide educational material delivered by the SRB [Time Frame: Pre-HIPEC to Day 0]

Improve overall post-operative QOL ratings at 3 months, relative to discharge [Time Frame: 3 months post discharge]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • 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
Intervention
  • Behavioral: HIPEC Orientation
  • Behavioral: Consultation with Survivorship Navigator
  • Other: Questionnaires
Study Arms / Comparison Groups1 / 0
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment10
GenderAll
AgesN/A - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion

- Patients who undergo CS and HIPEC for peritoneal surface malignancy

Administrative Information
NCTIDNCT01126346
Responsible Party,
SponsorWake Forest University Health Sciences
Verification DateJuly 2014
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