Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Wounds and Injuries

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Carcinoma, Ovarian Epithelial

Sarcoma

Recurrence

Hyperthermia

Fever

Mesothelioma

Mesothelioma, Malignant

Pseudomyxoma Peritonei

Colonic Neoplasms

Neoplasms, Germ Cell and Embryonal

Germinoma

Ovarian Neoplasms

Lung Neoplasms

Disease Attributes

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Adenocarcinoma

Adenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Malignant Mesothelioma

Ovarian Germ Cell Tumor

Central Nervous System Germinoma

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

HIPEC Orientation

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

Consultation with Survivorship Navigator

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)

Questionnaires

Richard McQuellon

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.

Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

HOPE Program: Quality of Life Enhancement and Survivorship Care

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)

Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).

Mean scores on the distress thermometer will be compared as well as individual patient changes.

Form to assess utility of the Survivorship Resource Book

Improve post-operative QOL ratings at 3 months, relative to discharge. Repeated measures analysis of covariance (ANCOVA) will be utilized with the FACT scales.

Wake Forest University Health Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)	NCT01126346	Advanced Malign... Carcinoma of th... Ovarian Sarcoma Ovarian Stromal... Pseudomyxoma Pe... Recurrent Colon... Recurrent Malig... Recurrent Ovari... Recurrent Ovari... Stage III Colon... Stage III Ovari... Stage III Ovari... Stage IV Colon ... Stage IV Ovaria... Stage IV Ovaria... Unspecified Chi...	HIPEC Orientati... Consultation wi... Questionnaires	-	Wake Forest University Health Sciences
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)	NCT01126346	Advanced Malign... Carcinoma of th... Ovarian Sarcoma Ovarian Stromal... Pseudomyxoma Pe... Recurrent Colon... Recurrent Malig... Recurrent Ovari... Recurrent Ovari... Stage III Colon... Stage III Ovari... Stage III Ovari... Stage IV Colon ... Stage IV Ovaria... Stage IV Ovaria... Unspecified Chi...	HIPEC Orientati... Consultation wi... Questionnaires	-	Wake Forest University Health Sciences
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)	NCT01126346	Advanced Malign... Carcinoma of th... Ovarian Sarcoma Ovarian Stromal... Pseudomyxoma Pe... Recurrent Colon... Recurrent Malig... Recurrent Ovari... Recurrent Ovari... Stage III Colon... Stage III Ovari... Stage III Ovari... Stage IV Colon ... Stage IV Ovaria... Stage IV Ovaria... Unspecified Chi...	HIPEC Orientati... Consultation wi... Questionnaires	-	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for consultation with survivorship navigator