Symptom Inventory for Gastrointestinal Stromal Tumors

NCT01178307 | Unknown

• 1 other identifier: 2010-0267
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to better understand the symptoms experienced by patients with GIST. There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year. You are being asked to take part in Part 3 of the study.

Conditions

Gastrointestinal Stromal Tumors

Keywords

GI cancers; GIST; Symptom Severity; Quality of Life; Questionnaire; M.D. Anderson Symptom Inventory; MDASI-GIST; patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors

  Descriptive statistics used to assess the distributional characteristics and demographics of the study population and to report how patients rate symptom severity and interference with function.

  Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.

Study Arms (3)

Part 1

Patient interview and developmental questionnaires

Behavioral: Questionnaires; Behavioral: Interview

Part 2

Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development

Behavioral: Questionnaires

Part 3

Patient MDASI-GIST Questionnaire

Behavioral: MDASI-GIST Questionnaire

Interventions

Questionnaires BEHAVIORAL

10 minutes to complete 3 questionnaires for development of MDASI-GIST

Also known as: survey

Part 1; Part 2

Interview BEHAVIORAL

Each interview will take approximately 30 minutes.

Part 1

MDASI-GIST Questionnaire BEHAVIORAL

Every 4 weeks for one year

Also known as: survey

Part 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UT MD Anderson Cancer Center Sarcoma and Surgical Oncology Clinics GIST Patients, their caregivers, doctors and nurses who are 18 years or older.

You may qualify if:

• years of age or older (Patient and family caregiver only)
• Ability to speak and read English (All participants)
• Residing where IVR service is available (Part 3, Patient only)
• Diagnosis of GIST confirmed by pathological analysis (Patient only)
• Starting new treatment (either surgical or medical) and planning to be followed at M.D. Anderson Cancer Center (Part 3, Patient only)
• Written consent to participate (All participants)
• At least 3 months from start of initial treatment (surgical or medical) for GIST (Part 2, Patient only)
• Family caregiver also willing to receive packet for expert panel participation (Part 2, Patient only)
• Physician or nurse with at least 5 years experience caring for patients with GIST (Professional expert only)
• At least one publication in the last 5 years dealing with GIST (Physician professional expert only)
• Identification as a family caregiver by a patient with GIST (Family caregiver only)
• Patient also willing to receive packet for expert panel participation (Family caregiver only)

You may not qualify if:

• Medical condition or impaired performance status that would preclude participation in the study (Patient only)
• Diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (Patient only)
• Active treatment (systemic drug therapy or radiation therapy) for a second malignancy (Patient only)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

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

• Loretta A. Williams, PhD, MSN

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 10, 2010
• Study Start: July 29, 2010
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)