- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126346
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (HOPE)
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.
Study Overview
Status
Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Pseudomyxoma Peritonei
- Stage IV Ovarian Epithelial Cancer
- Stage IV Ovarian Germ Cell Tumor
- Ovarian Sarcoma
- Recurrent Ovarian Epithelial Cancer
- Stage IV Colon Cancer
- Recurrent Colon Cancer
- Carcinoma of the Appendix
- Ovarian Stromal Cancer
- Recurrent Ovarian Germ Cell Tumor
- Stage III Colon Cancer
- Stage III Ovarian Epithelial Cancer
- Stage III Ovarian Germ Cell Tumor
- Recurrent Malignant Mesothelioma
- Advanced Malignant Mesothelioma
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion
- Patients who undergo CS and HIPEC for peritoneal surface malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
Other Names:
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 Names:
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline to 3 months post discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Pre-HIPEC to Day 0
|
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.
|
Pre-HIPEC to Day 0
|
Provide educational material delivered by the SRB
Time Frame: Pre-HIPEC to Day 0
|
Form to assess utility of the Survivorship Resource Book
|
Pre-HIPEC to Day 0
|
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.
|
3 months post discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard McQuellon, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Adenocarcinoma, Mucinous
- Neoplasms, Germ Cell and Embryonal
- Lung Neoplasms
- Recurrence
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Colonic Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Pseudomyxoma Peritonei
- Germinoma
Other Study ID Numbers
- IRB00013172
- NCI-2010-00980
- CCCWFU 97110 (OTHER: Wake Forest University Health Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Childhood Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
Children's Cancer and Leukaemia GroupUnknownUnspecified Childhood Solid Tumor, Protocol SpecificIreland, United Kingdom
Clinical Trials on HIPEC Orientation
-
University of Sao PauloCompletedOsteoarthritis HandBrazil
-
Universidade Federal do ParanáCompletedAdolescent Behavior
-
VA Office of Research and DevelopmentYale UniversityCompletedVeterans' Disability ClaimsUnited States
-
University of California, San DiegoRecruitingColorectal Cancer | Ovarian Carcinoma | Peritoneal Metastases | Appendix CancerUnited States
-
Ma ZheCompleted
-
IRCCS Eugenio MedeaCompleted
-
Universidade Federal FluminenseUnknown
-
PEDRO VILLAREJO CAMPOSUniversity of Castilla-La Mancha; Hospital General de Ciudad RealUnknownEpithelial Ovarian CancerSpain
-
Ottawa Hospital Research InstituteRecruitingHip Osteoarthritis | Hip ArthritisCanada
-
Central Hospital, Nancy, FranceUnknownTemporomandibular Disorder | Pathophysiology | TherapyFrance