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Clinical Trials/NCT02515383
NCT02515383Active, not recruitingNot Applicable

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

M.D. Anderson Cancer Center2 sites in 1 country41 target enrollmentStarted: November 9, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
41
Locations
2
Primary Endpoint
Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
13 Years to 17 Years (Child)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Performance of MD Anderson Symptom Inventory (MDASI) modified for use with adolescents (adolescent version)

Time Frame: 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 Outcomes

  • Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life(Up to 3 months)
  • Feasibility of collection methods(Up to 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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