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Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer

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ClinicalTrials.gov Identifier: NCT02108028
Recruitment Status : Recruiting
First Posted : April 9, 2014
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

- There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful.

Objective:

- To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve communication about advanced care planning.

Eligibility:

- Adults 18 to 39 years old being treated for cancer.

Design:

  • Participants will answer questions about their age, gender, employment, religion, health, and marital status. They will also complete several brief questionnaires:

    1. General Anxiety Short Form
    2. Peace, Equanimity and Acceptance in the Cancer Experience
    3. Functional Assessment of Social Support
    4. Quality of Communication
    5. Prior Communication about Advanced Care Planning
  • Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations.
  • The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.

Condition or disease
HIV Cancer Chronic Granulomatous Disease Dock 8 Deficiency

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer and Other Chronic Illnesses
Actual Study Start Date : April 3, 2014
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2020


Group/Cohort
Cohort 1
Patients with children
Cohort 2
Patients living independently
Cohort 3
Non-Patient Participants



Primary Outcome Measures :
  1. Preceived helpfulness [ Time Frame: 2 Months ]
    To determine whether engaging in advance care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness and/or improved communication about ACP with family, friends and/or health care providers.


Secondary Outcome Measures :
  1. Helpfulness vs living & parental status [ Time Frame: 2 Months ]
    To examine the helpfulness of VMC by living status (independent living vs. with family of origin) and parental status.

  2. Benefit vs Burden [ Time Frame: 2 Months ]
    To examine the perceived benefit and burden of completing VMC.

  3. Feasibility [ Time Frame: 2 Months ]
    To assess whether further revisions are needed to VMC for use with YA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients must be diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.@@@Non-Patient participants must be family/friend and/or health care providers of patients diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
Criteria
  • ELIGIBILITY CRITERIA FOR PATIENT PARTICIPANTS (COHORT 1):

INCLUSION CRITERIA:

  • Patients must be between ages: 18 through 39 years
  • Patients must be diagnosed with cancer or other chronic illness.
  • Patients must give informed consent.
  • Patients must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS; Appendix
  • 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.
  • Cognitive impairment which in the judgment of the Principal or Associate Investigatorwould compromise the patient s ability to understand the VMC 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 or complete this study.
  • Participants who have already completed the Voicing My CHOiCES tool.

ELIGIBILITY CRITERIA FOR NON-PATIENT PARTICPANTS (COHORT 2):

INCLUSION CRITERIA:

  • Subject must be greater than or equal to 18 years of age
  • Family/friend and/or health care providers must be English or Spanish speaking.
  • Family/friend and health care providers must provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108028


Contacts
Contact: Lori Wiener, Ph.D. (240) 760-6419 lori.wiener@nih.gov

Locations
United States, California
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33647
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7030
United States, Texas
Cook Childrens Hospital Recruiting
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lori Wiener, Ph.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02108028     History of Changes
Other Study ID Numbers: 140079
14-C-0079
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 21, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Advance Care Planning Guide
End-of-Life

Additional relevant MeSH terms:
Granulomatous Disease, Chronic
Phagocyte Bactericidal Dysfunction
Leukocyte Disorders
Hematologic Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes
Immune System Diseases