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

NCT ID: NCT01136824

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Sarcoma

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Sarcoma Subjects

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

Questionnaires

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are receiving doxorubicin plus ifosfamide (AI)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hussein Tawbi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Charles Horn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh, Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10-046

Identifier Type: -

Identifier Source: org_study_id

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