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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01126346
First received: May 13, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
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
Behavioral: HIPEC Orientation
Behavioral: Consultation with Survivorship Navigator
Other: Questionnaires

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: HOPE Program: Quality of Life Enhancement and Survivorship Care

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-HIPEC to Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Improve post-operative QOL ratings at 3 months, relative to discharge. Repeated measures analysis of covariance (ANCOVA) will be utilized with the FACT scales.


Enrollment: 10
Study Start Date: May 2010
Study Completion Date: October 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Behavioral: HIPEC Orientation
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
Other Name: orientation
Behavioral: Consultation with Survivorship Navigator
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
Other Name: Consultation
Other: Questionnaires
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)
Other Name: Questionnaires

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Patients who undergo CS and HIPEC for peritoneal surface malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126346

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Richard McQuellon Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01126346     History of Changes
Other Study ID Numbers: CCCWFU 97110, NCI-2010-00980
Study First Received: May 13, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Colonic Neoplasms
Mesothelioma
Pseudomyxoma Peritonei
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adenoma
Neoplasms, Mesothelial
Neoplasms, Cystic, Mucinous, and Serous
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014