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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
May 13, 2010
May 19, 2010
May 30, 2017
May 2010
April 2011   (Final data collection date for primary outcome measure)
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)
  • 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-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)
Complete list of historical versions of study NCT01126346 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
HOPE Program: Quality of Life Enhancement and Survivorship Care

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • 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
    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)
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.
Interventions:
  • Behavioral: HIPEC Orientation
  • Behavioral: Consultation with Survivorship Navigator
  • Other: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2013
April 2011   (Final data collection date for primary outcome measure)

Inclusion

  • Patients who undergo CS and HIPEC for peritoneal surface malignancy
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01126346
CCCWFU 97110
NCI-2010-00980
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
Not Provided
Principal Investigator: Richard McQuellon Wake Forest University Health Sciences
Wake Forest University Health Sciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP