Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid Tumors and High-Grade Brain Tumors

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Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid Tumors and High-Grade Brain Tumors

Study Purpose

This clinical trial studies whether educational tools work to improve early advance care planning (ACP) in adolescents and young adults (AYAs) with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and high-grade brain tumors. The incidence of AYA cancers is on the rise with approximately 90,000 new diagnoses yearly in the United States. Cancer remains the leading cause of disease-related death among AYAs, which could be due to patients having more advanced disease at presentation. It is recommended that AYAs begin ACP conversations at the start of treatment. ACP includes clarifying goals of care, discussions about end-of-life preferences, and completing a legal document that states the treatment or care a person wishes to receive or not receive if they become unable to make medical decisions (advance directive). The educational tools in this study include an early ACP educational video featuring AYAs with cancer and an ACP appointment geared for AYAs. Patients can access and watch the educational video at home prior to their scheduled ACP appointment. During the ACP appointment, a tailored ACP guide made specifically for AYAs is reviewed and questions regarding ACP are answered. This may help to introduce the importance of key ACP concepts, which may improve early ACP in AYAs with advanced solid tumors and high-grade brain tumors.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 39 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 18-39 at initial cancer diagnosis.

- Recently diagnosed (defined as 12 months or less from initial diagnosis or advance stage relapse) with either a stage III/IV solid malignancy or high-grade brain tumor.

This includes patients who have stage III/IV recurrence of previously stage I/II solid malignancy.

- Actively receiving primary oncologic care at Mayo Clinic Arizona.

- Able to read, understand, and speak English.

Exclusion Criteria:

- Age < 18 or > 39 at initial cancer diagnosis.

- Diagnosed with stage I/II solid malignancy, low-grade brain tumor, or hematologic malignancy.

- Not receiving primary oncologic care at Mayo Clinic Arizona.

- Unable to read, understand, and speak English.

- Patients > 12 months from initial diagnosis or advanced stage relapses, in survivorship or on hospice.

- No internet or computer/smart phone access

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07174661
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Allison C. Rosenthal, DO
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Malignant Solid Neoplasm, Malignant Brain Neoplasm, Recurrent Advanced Malignant Solid Neoplasm
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Supportive care (early ACP)

Patients watch a brief, on-demand early ACP educational video at baseline and then one month later attend an ACP appointment with either an AYA social worker or AYA palliative medicine physician assistant over 1 hour.

Interventions

Behavioral: - Advance Care Planning

Attend ACP appointment

Other: - Educational Intervention

Watch on-demand early ACP educational video

Other: - Electronic Health Record Review

Ancillary studies

Other: - Survey Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Scottsdale 5313457, Arizona 5551752

Status

Recruiting

Address

Mayo Clinic in Arizona

Scottsdale 5313457, Arizona 5551752, 85259

Site Contact

Sey Oloyede

[email protected]

507-538-6811