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

NCT01136824 | Completed DMC

• 1 other identifier: 10-046
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue Sarcoma

Keywords

Sarcoma; questionnaire; doxorubicin plus ifosfamide (AI)

Outcome Measures

Primary Outcomes (1)

• To determine the extent of symptom burden and quality of life in sarcoma patients receiving AI chemotherapy.

  2 years

Study Arms (1)

Sarcoma Subjects

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

Other: Questionnaires

Interventions

Questionnaires 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

Sarcoma Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who are receiving doxorubicin plus ifosfamide (AI)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh, Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hussein Tawbi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Charles Horn, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

US (1)