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 or HIV Infection

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01445145
First received: September 30, 2011
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

Background:

  • Few resources exist for helping adolescents and young adults with cancer or HIV disease understand their changing physical, emotional and social needs when treatment is no longer effective.
  • An advance directive document called Five Wishes has had particular success with the adult population because of the consideration of personal, emotional and spiritual needs in addition to medical and legal concerns.

Objectives:

-To learn which questions in Five Wishes are useful for adolescents and young adults and to then create a new document that reflects the issues they feel are most appropriate for people with cancer or HIV disease.

Eligibility:

-Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.

Design:

  • Stage 1: Participants go through each question in Five Wishes and respond to whether they feel the questions are useful.
  • Stage 2: Participants are asked to compare each question from Five Wishes to a newly developed document based on the feedback received during first stage of the study.
  • Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter the study.

Condition
Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
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 or HIV Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 63
Study Start Date: January 2007
Detailed Description:

Background:

  • Discussing end of life (EoL) care with adolescents and young adults can be one of the most difficult aspects of living with a life threatening disease.
  • Few established resources exist to aid this population in accepting and understanding their changing physical, emotional and social needs when treatment is no longer effective. Standards in palliative care suggest that discussion of end of life issues be routine and commence soon after diagnosis.
  • While many helpful documents exist to facilitate such conversations with adults, few address the particular concerns and needs of adolescents and young adults.
  • One advance directive (AD) document, Five Wishes, has had particular success with the adult population because of the consideration of 'personal, emotional and spiritual needs' in addition to medical and legal concerns.

Objective:

  • To determine if adolescents and young adults living with advanced cancer or HIV disease feel that an AD document, such as Five Wishes, is useful in addressing end of life issues.
  • To develop and perform a pilot evaluation of a modified age-appropriate advance care planning tool for young adults and adolescents based on Five Wishes that reflects the participants opinions on which questions they feel are most useful and additional items that might be helpful.

Eligibility:

  • Age: 16 to 30 years
  • Known metastatic, progressive or recurrent cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.

Design:

-A descriptive study of attitudes of young adults (16-30 years) with cancer or HIV disease concerning the questions contained in the AD document Five Wishes as well as a comparison between Five Wishes and a modified version of that document.

  Eligibility

Ages Eligible for Study:   16 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Age: 16 to 30 years
  • Patients at NIH or participating site must have 1) a diagnosis of metastatic, recurrent, or progressive cancer with a mean survival rate of 2 years or less or 2) a diagnosis of perinatal or early life transfusion associated HIV infection. The treatment protocol PI or attending physician must consent to have a patient entered into this protocol. Newly diagnosed patients must have completed at least three cycles of chemotherapy.
  • For patients less than 18 years of age, a legal guardian must provide informed consent and the patients must sign an assent document.
  • Patients greater than 18 years of age must give informed consent.
  • Patients less than 18 years of age must have a score of 40 or higher on Lanksy/Karnofsky, as determined by the medical team at the time of enrollment.
  • Patients greater than 18 years of age must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) at the time of enrollment.
  • Patients must be English or Spanish speaking.

EXCLUSION CRITERIA:

  • Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator, or consulting psychiatrist would compromise the patient s ability to engage in the intervention or is likely to interfere with the study procedures or results.
  • Previously identified cognitive impairment which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to understand the Five Wishes material or is likely to interfere with the study procedures or results.
  • Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the research team would compromise the patient s ability to tolerate this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445145

Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007-2197
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Lori Wiener, Ph.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01445145     History of Changes
Obsolete Identifiers: NCT00445640
Other Study ID Numbers: 070085, 07-C-0085
Study First Received: September 30, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
End-of-Life
Advance Directive
Pediatric Cancer
Adolescents
Young Adults

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 31, 2014