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
Conditions
Brief summary
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.
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.
Interventions
BEHAVIORALHIPEC Orientation
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
BEHAVIORALConsultation 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
OTHERQuestionnaires
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)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Inclusion * Patients who undergo CS and HIPEC for peritoneal surface malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduce pre-treatment distress and anxiety | Pre-HIPEC to Day 0 | Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale). |
| Improve pre-treatment self-efficacy | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed