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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126346
First Posted: May 19, 2010
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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: Intervention Model: Single Group Assignment
Masking: None (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 Wake Forest University Health Sciences:

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 ]
    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 ]
    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.


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)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Patients who undergo CS and HIPEC for peritoneal surface malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126346


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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01126346     History of Changes
Other Study ID Numbers: CCCWFU 97110
NCI-2010-00980
First Submitted: May 13, 2010
First Posted: May 19, 2010
Last Update Posted: May 30, 2017
Last Verified: July 2014

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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