Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)
NCT ID: NCT02515383
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
41 participants
OBSERVATIONAL
2016-11-09
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Part 1 (MDASI questionnaire, interview)
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.
Interview
Complete cognitive debriefing interview
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete MDASI questionnaire
Part 2 (MDASI questionnaires, interview)
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.
Interview
Complete cognitive debriefing interview
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete MDASI questionnaire
Interventions
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Interview
Complete cognitive debriefing interview
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete MDASI questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosis of active psychosis, developmental delay, or severe cognitive impairment documented by primary physician in medical record
13 Years
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Rhonda Robert
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-07335
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0271
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0271
Identifier Type: -
Identifier Source: org_study_id