Purpose:
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.
Criteria:
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