Malignant Solid Neoplasm Clinical Trial
Official title:
Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)
Verified date | April 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 41 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version) | 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. | Up to 3 months | |
Secondary | Feasibility of collection methods | Patient cognitive debriefing responses about ease of completion based on method and preference for method of completion as well as percentage of successful completions by method during longitudinal assessment in Part 2 will be used to determine the feasibility of the collection methods. | Up to 3 months | |
Secondary | Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life | The European Quality of Life Five Dimension Questionnaire (EuroQol EQ-5D) and a single-item quality of life question will be compared to MDASI (adolescent version) symptom severity and interference to establish concurrent validity. | Up to 3 months |
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