Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Interview
Complete cognitive debriefing interview
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: 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. |
Other: Interview
Complete cognitive debriefing interview
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Complete MDASI questionnaire
|
Outcome Measures
Primary Outcome Measures
- Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version) [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 Outcome Measures
- Feasibility of collection methods [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.
- Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to speak and read English
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Diagnosis of cancer, confirmed pathologically or clinically
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Being seen by a healthcare provider at MD Anderson Cancer Center
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Written assent by subject and written consent by parent/guardian for participation
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Starting a cycle of chemotherapy, starting radiation therapy, or starting preparative regimen for stem cell transplantation (Part 2 only)
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Lori Williams, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2015-0271
- NCI-2020-07335
- 2015-0271