Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Detailed description
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.
Interventions
OTHERInterview
Complete cognitive debriefing interview
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Complete MDASI questionnaire
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRhonda Robert
M.D. Anderson Cancer Center
Outcome results
None listed