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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07335 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-1021 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Complete cognitive debriefing interview |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents diagnosed with cancer being seen at MD Anderson Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| Rhonda Robert | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Complete MDASI questionnaire |
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| 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |