M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT02515383
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.
This study is active but is not currently recruiting participants.
13 year–17 year
All sexes
Observational
Houston, Texas, 77030, United States
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.
OUTLINE:
Part 1: Patients complete the MDASI questionnaire and then complete a cognitive debriefing interview regarding its comprehensibility, the acceptability of each item, and whether any important symptoms are missing from the questionnaire.
Part 2: Patients complete the MDASI questionnaire twice (1-7 days apart). Approximately 1 week after beginning standard of care treatment, patients complete the MDASI questionnaire at 4 additional time points, each 1 week apart. Patients may also complete a cognitive debriefing interview regarding its comprehensibility, the acceptability of each item, and whether any important symptoms are missing from the questionnaire.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Complete cognitive debriefing interview
Ancillary studies
Other names: Quality of Life Assessment
Complete MDASI questionnaire
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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.
M.D. Anderson Cancer Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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