Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)
Study Overview
Brief Summary
This study investigates how the MD Anderson Symptom Inventory questionnaire modified for use with adolescents performs in adolescent patients with cancer. Conducting interviews with adolescents about the MD Anderson Symptom Inventory may help researchers improve the questionnaire to better understand the symptoms experienced by 13-17 year old patients with cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. To examine how the MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version) performs in adolescent patients who have various cancer types, who have undergone various treatments, and who have varying levels of symptom burden.
SECONDARY OBJECTIVES:
I. To explore the feasibility of various methods for collecting MDASI (adolescent version) data (for example, paper-and-pencil forms, face-to-face and telephone interviews, electronic data capture methods such as electronic tablets or automated telephone systems.
II. To evaluate the MDASI (adolescent version) as an estimate of functional status and quality of life in adolescent cancer patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to speak and read English
- •Diagnosis of cancer, confirmed pathologically or clinically
- •Being seen by a healthcare provider at MD Anderson Cancer Center
- •Written assent by subject and written consent by parent/guardian for participation
- •Starting a cycle of chemotherapy, starting radiation therapy, or starting preparative regimen for stem cell transplantation (Part 2 only)
Exclusion Criteria
- •Medical condition, as determined by the attending physician, that would preclude participation in the study
- •Diagnosis of active psychosis, developmental delay, or severe cognitive impairment documented by primary physician in medical record
Outcomes
Primary Outcomes
Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)
Time Frame: Up to 3 months
Data analysis for the cognitive debriefing portion of the study will be qualitative in nature. Construct validity will be determined using factor analysis. Internal consistency reliability will be assessed using Cronbach coefficient alphas.
Secondary Outcomes
- Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life(Up to 3 months)
- Feasibility of collection methods(Up to 3 months)