Advanced Care Planning Using the Five Wishes Document in Young Patients With Metastatic, Recurrent, or Progressive Cancer or HIV Disease - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00445640

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.

Condition	Intervention
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Other: counseling intervention Procedure: psychosocial assessment and care

MedlinePlus related topics: AIDS Advance Directives Cancer

U.S. FDA Resources

Study Type:	Interventional
Official Title:	An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent or Progressive Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Perceived helpfulness of the standard Five Wishes advance directive as measured by a 5-point Likert scale [ Designated as safety issue: No ]
Development of a modified, age-appropriate advanced care planning tool based on the Five Wishes advance directive that reflects patient opinions on planning end-of-life care [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	December 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	16 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445640

Locations

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lori Wiener, PhD

NCI - Pediatric Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000534414, NCI-07-C-0085
Study First Received:	March 7, 2007
Last Updated:	April 18, 2009
ClinicalTrials.gov Identifier:	NCT00445640 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

transitional care planning
psychosocial effects/treatment
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome
Recurrence

ClinicalTrials.gov processed this record on May 06, 2009