Clinical trial NCT02515383: Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)
Official title: Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-04
Enrollment: 41
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents diagnosed with cancer being seen at MD Anderson Cancer Center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Feasibility of collection methods
timeFrame: Up to 3 months
measure: Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lori Williams
role: PRINCIPAL_INVESTIGATOR
References: