Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

July 26, 2016 updated by: University of Pittsburgh
Assessments (survey data) in this study are designed to sample the symptom burden of patients undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in the treatment plan for these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh, Hillman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Soft tissue sarcoma patients treated with the adjuvant and neoadjuvant chemotherapy protocol of doxorubicin plus ifosfamide (AI)

Description

Inclusion Criteria:

  • Patients who are receiving doxorubicin plus ifosfamide (AI)

Exclusion Criteria:

  • There is no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sarcoma Subjects
Soft tissue sarcoma patients treated with the adjuvant and neoadjuvant chemotherapy protocol of doxorubicin plus ifosfamide (AI)
Other: Questionnaires

Subjects will be given a series of questionnaires to assess the effect of AI chemotherapy, and the possible role of tumor load, on the amount of symptoms. The extent of nausea, vomiting, fatigue, anxiety, sleep disturbance, and cognitive changes will be measured. In adjuvant chemotherapy patients, we will also assess the relationship between tumor size and amount of chemotherapy-induced symptoms. These questionnaires will involve the following assessments:

Demographic & health Trait anxiety Quality of life Nausea Expectations Anxiety & total mood disturbance Nausea & vomiting Multiple symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the extent of symptom burden and quality of life in sarcoma patients receiving AI chemotherapy.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Hussein Tawbi, MD, University of Pittsburgh
  • Principal Investigator: Charles Horn, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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