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Completed

NCT Number: NCT00804258

Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

RATIONALE: Palliative care may help improve the quality of life of patients with ovarian cancer who are undergoing intraperitoneal chemotherapy.

PURPOSE: This clinical trial is studying palliative care in patients with ovarian cancer who are undergoing intraperitoneal chemotherapy.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

OBJECTIVES:

  • Describe symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and the impact of these symptoms/concerns on the quality of life (QOL) of patients with ovarian cancer undergoing IP chemotherapy. (Part I)
  • Analyze care received and resource utilization of these patients, including length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters. (Part I)
  • Develop palliative care assessment measures and interventions that apply to IP chemotherapy. (Part II)
  • Implement a palliative care intervention in a pilot of 6 patients. (Part II)
  • Describe the impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed. (Part II)

OUTLINE: This is a two-part study.

  • Part I (retrospective portion): Patients who have undergone intraperitoneal (IP) chemotherapy within the past 6-12 months undergo a retrospective interview and chart audit to identify their needs and experiences.
  • Part I (prospective portion): Patients are followed monthly for up to 6 months during IP chemotherapy to provide information about usual care and to identify needs and palliative care concerns. Patients also complete a quality-of-life (QOL) questionnaire (COH QOL Ovarian tool) and undergo a prospective interview.
  • Part II (intervention): Patients undergo comprehensive palliative care assessment, a patient teaching session prior to the initiation of IP chemotherapy, and a palliative care intervention during IP chemotherapy. Patients also complete a QOL questionnaire and undergo an interview. Patients are followed monthly for up to 6 months during IP chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian cancer
  • Under the care of the Medical Oncology Department at the City of Hope National Medical Center
  • Undergoing intraperitoneal chemotherapy

PATIENT CHARACTERISTICS:

  • Life expectancy > 6 months
  • Speaks English or Spanish

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

intraperitoneal chemotherapy

Drug

Educational Intervention

Other

medical chart review

Other

Questionnaire Administration

Other

assessment of therapy complications

Procedure

end-of-life treatment/management

Procedure

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. Symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and their impact on quality of life (QOL)

    Time frame: 6 months from study entry

  2. Length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters

    Time frame: 6 months from study entry

  3. Development of palliative care assessment measures and interventions that apply to IP chemotherapy

    Time frame: 6 months from study start

  4. Implementation of a palliative care intervention

    Time frame: 6 months from study entry

  5. Impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed

    Time frame: 6 months from study entry

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Integration of Palliative Care in Use of Intra-Peritoneal Chemotherapy for Ovarian Cancer

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2008
Registry last updated
Nov 6, 2015

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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