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

NCT02108028 | Completed

• 2 other identifiers: 14007914-C-0079
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 9

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(TM) 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:

• 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.

Conditions

HIV; Cancer; Chronic Granulomatous Disease; Dock 8 Deficiency

Keywords

Advance Care Planning Guide; End of life; Natural History

Outcome Measures

Primary Outcomes (3)

• Perceived helpfulness

  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.

  2 months

• Improved outcomes

  To determine whether engaging in advanced 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.

  2 months

• Feasability

  To assess the helpfulness of the changes made to the original VMC as compared to the revised VMC document.

  2 months

Secondary Outcomes (3)

• Helpfullness vs living & parental status

  2 months

• Feasibility

  2 months

• Benefit vs burden

  2 months

Study Arms (7)

Cohort 1A / Initial Young Adults with Children

Young adults who have a child(ren) and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE

Cohort 1B / Comparison Young Adults with Children

Young adults who have children and are 18- 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site.

Cohort 2A / Initial Independent Young Adults

Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE

Cohort 2B / Comparison Independent Young Adults

Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site.

Cohort 3A / Initial Young Adults No Children, Not Independent

Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE

Cohort 3B / Comparison Young Adults No Children, Not Independent

Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site.

Cohort 4 / Non-patient participants

Family members, friends, or health care providers of patient participant. COMPLETE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18-39 must be diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. 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.

You may qualify if:

• 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.
• Cohorts 1B and 2B must be English speaking only.

You may not qualify if:

• 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 4):
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33647, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Rhode Island Hospital (Lifespan)

Providence, Rhode Island, 02903, United States

Location

Cook Childrens Hospital

Fort Worth, Texas, 76104, United States

Location

Related Publications (3)

• Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42. doi: 10.1016/s0031-3955(02)00035-4.

  PMID: 12430624 BACKGROUND

• Bellizzi KM, Smith A, Schmidt S, Keegan TH, Zebrack B, Lynch CF, Deapen D, Shnorhavorian M, Tompkins BJ, Simon M; Adolescent and Young Adult Health Outcomes and Patient Experience (AYA HOPE) Study Collaborative Group. Positive and negative psychosocial impact of being diagnosed with cancer as an adolescent or young adult. Cancer. 2012 Oct 15;118(20):5155-62. doi: 10.1002/cncr.27512. Epub 2012 Mar 13.

  PMID: 22415815 BACKGROUND

• Nilsson ME, Maciejewski PK, Zhang B, Wright AA, Trice ED, Muriel AC, Friedlander RJ, Fasciano KM, Block SD, Prigerson HG. Mental health, treatment preferences, advance care planning, location, and quality of death in advanced cancer patients with dependent children. Cancer. 2009 Jan 15;115(2):399-409. doi: 10.1002/cncr.24002.

  PMID: 19110677 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Granulomatous Disease, Chronic; Death

Condition Hierarchy (Ancestors)

Phagocyte Bactericidal Dysfunction; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lori S Wiener, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 9, 2014
• Study Start: April 3, 2014
• Primary Completion: August 16, 2023
• Study Completion: July 24, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (9)