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Completed

NCT Number: NCT01126346

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

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.

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Key information

Conditions

Advanced Malignant Mesothelioma Adenocarcinoma Adenocarcinoma, Mucinous Adenoma Adnexal Diseases Appendiceal Neoplasms Carcinoma Carcinoma of the Appendix Carcinoma, Ovarian Epithelial Cecal Diseases Cecal Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Ovarian Diseases Ovarian Neoplasms Ovarian Sarcoma Ovarian Stromal Cancer Pleural Neoplasms Pseudomyxoma Peritonei Recurrent Colon Cancer Recurrent Malignant Mesothelioma Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Thoracic Neoplasms Unspecified Childhood Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • Patients who undergo CS and HIPEC for peritoneal surface malignancy

Treatment and study plan

HIPEC Orientation

Behavioral

Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session

Other names: orientation

Consultation with Survivorship Navigator

Behavioral

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: Consultation

questionnaires

Other

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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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.

  3. Provide educational material delivered by the SRB

    Time frame: Pre-HIPEC to Day 0

    Form to assess utility of the Survivorship Resource Book

  4. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

HOPE Program: Quality of Life Enhancement and Survivorship Care

Acronym: HOPE

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
May 19, 2010
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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