Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
— HOPEOfficial title:
HOPE Program: Quality of Life Enhancement and Survivorship Care
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2013 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion - Patients who undergo CS and HIPEC for peritoneal surface malignancy |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population | 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 | Reduce pre-treatment distress and anxiety | Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale). | Pre-HIPEC to Day 0 | |
Secondary | Improve pre-treatment self-efficacy | Mean scores on the distress thermometer will be compared as well as individual patient changes. | Pre-HIPEC to Day 0 | |
Secondary | Provide educational material delivered by the SRB | Form to assess utility of the Survivorship Resource Book | Pre-HIPEC to Day 0 | |
Secondary | Improve overall post-operative QOL ratings at 3 months, relative to 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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