Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Interview; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02515383

2015-0271 (Other Identifier)

NCI-2020-07335 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Part 1 (MDASI questionnaire, interview)

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Interview

Part 2 (MDASI questionnaires, interview)

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Interview