Washington, District of Columbia 20007

  • Unspecified Childhood Solid Tumor, Protocol Specific


RATIONALE: Evaluating a planning tool that helps young patients with advanced cancer develop an advance directive may be useful in addressing end-of-life issues. PURPOSE: This clinical trial is evaluating use of the Five Wishes document to develop an advance directive in young patients with metastatic, recurrent, or progressive cancer, or HIV disease.

Study summary:

OBJECTIVES: - Determine if an advance directive document such as Five Wishes is useful in addressing end-of-life issues in adolescents and young adults with advanced cancer or HIV disease. - Develop and evaluate a modified, age-appropriate advanced care planning tool that reflects the opinions of these patients based on the Five Wishes document and the questions or other topics they feel are most useful in planning end-of-life care. OUTLINE: This is a multicenter, two-stage, pilot study. Patients are stratified according to age (16 to 19 years vs 20 to 30 years). Patients are enrolled into either stage 1 or stage 2. - Stage 1: Patients complete an advanced care planning (ACP) readiness assessment to evaluate their willingness to discuss end-of-life issues. Patients who do not meet readiness criteria are given the option of being contacted in 1 month to determine their readiness at that time. Patients who feel comfortable discussing end-of-life issues are scheduled for an interview. During the interview, patients read and discuss the Five Wishes document with the principal investigator (PI) or an associate investigator (AI). Patients assess each item in the document for applicability to themselves and to other people their age. Patients are asked to provide feedback on the perceived helpfulness of the document by commenting on which questions and statements are the most and least helpful; what questions, if any, should be added; and what materials should be removed and the reason for their removal. Based on the information provided by patients, a modified advance directive is created. - Stage 2: Patients complete an ACP readiness assessment as in stage 1. Patients who meet readiness criteria at the time of the assessment or at the 1-month re-evaluation are scheduled for an interview with the PI or AI. During the interview, patients and investigators read and discuss the original Five Wishes document as well as the modified version created in stage 1. Patients are then asked to evaluate the questions in each document and determine which version of the questions would be more helpful in discussing end-of-life issues with family and friends. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Diagnosis of cancer or HIV disease - Metastatic, recurrent, or progressive disease - Currently enrolled in an active treatment protocol at the National Institutes of Health (NIH) or participating site - Participation in this study is contingent upon consent of principal investigator or attending physician of primary treatment protocol - Newly diagnosed patients with cancer must have completed ≥ 3 courses of chemotherapy PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0-3 (patients > 18 years of age) OR Lansky/Karnofsky PS 40-100% (patients < 18 years of age) - Able to speak English or Spanish - No psychotic symptoms or severe psychological distress that would preclude study participation or compliance or interfere with study results - No previously identified cognitive impairment that would compromise a patient's ability to understand the Five Wishes document, preclude study compliance, or interfere with study results - No clinically significant systemic illness (i.e., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would preclude study compliance PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Any concurrent therapy or investigational agent received while participating in another NIH study allowed



Primary Contact:

Principal Investigator
Lori Wiener, PhD
NCI - Pediatric Oncology Branch

Backup Contact:


Location Contact:

Washington, District of Columbia 20007
United States

Clinical Trials Office - Lombardi Comprehensive Cancer Center
Phone: 202-444-0381

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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