Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (HOPE)
This study is ongoing, but not recruiting participants.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01126346
First received: May 13, 2010
Last updated: January 31, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2010 |
| 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
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 University |
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: | January 31, 2013 |
| 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 May 22, 2013