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HOPE Program: Quality of Life Enhancement and Survivorship Care


N/A
N/A
N/A
Open (Enrolling)
Both
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

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Trial Information

HOPE Program: Quality of Life Enhancement and Survivorship Care


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.

Inclusion Criteria


Inclusion

- Patients who undergo CS and HIPEC for peritoneal surface malignancy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome 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)

Outcome Time Frame:

Baseline to 3 months post discharge

Safety Issue:

No

Principal Investigator

Richard McQuellon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 97110

NCT ID:

NCT01126346

Start Date:

May 2010

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Colonic Neoplasms
  • Mesothelioma
  • Pseudomyxoma Peritonei
  • Neoplasms, Germ Cell and Embryonal
  • Germinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Sarcoma

Name

Location
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157