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

NCT ID: NCT02515383

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-09

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Interview

Intervention Type OTHER

Complete cognitive debriefing interview

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Complete MDASI questionnaire

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.

Interview

Intervention Type OTHER

Complete cognitive debriefing interview

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Complete MDASI questionnaire

Interventions

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Interview

Complete cognitive debriefing interview

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Complete MDASI questionnaire

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rhonda Robert

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2020-07335

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0271

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0271

Identifier Type: -

Identifier Source: org_study_id