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

NCT02515383 | Active Not Recruiting

• 2 other identifiers: 2015-0271NCI-2020-07335
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Feasibility of collection methods

  Up to 3 months

• Evaluation of the MDASI (adolescent version) as an estimate of functional status and quality of life

  Up to 3 months

Study Arms (2)

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.

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

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.

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

Interventions

Interview OTHER

Complete cognitive debriefing interview

Part 1 (MDASI questionnaire, interview); Part 2 (MDASI questionnaires, interview)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Part 1 (MDASI questionnaire, interview); Part 2 (MDASI questionnaires, interview)

Questionnaire Administration OTHER

Complete MDASI questionnaire

Part 1 (MDASI questionnaire, interview); Part 2 (MDASI questionnaires, interview)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents diagnosed with cancer being seen at MD Anderson Cancer Center

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rhonda Robert

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 4, 2015
• Study Start: November 9, 2016
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)