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NCT Number: NCT07174661

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

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.

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Key information

Conditions

Advanced Malignant Solid Neoplasm Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Malignant Brain Neoplasm Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Recurrent Advanced Malignant Solid Neoplasm

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-39 at initial cancer diagnosis
  • Patient <18 years of age are not included in this pilot as Mayo Clinic in Arizona (MCA) does not treat pediatric patients
  • 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
  • Those who have completed prior advanced directive documents are still eligible to participate.

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

Treatment and study plan

Advance care planning

Behavioral

Attend ACP appointment

Educational Intervention

Other

Watch on-demand early ACP educational video

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Electronic Health Record Review

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of implementing routine, early Advance Care Planning (ACP)

    Time frame: Up to 1 year

    Feasibility is achieved if 60% of participants can complete the baseline survey, view the pre-appointment educational video, and attend the hour-long ACP appointment. Baseline survey completion will be defined as answering at least 80% of the survey questions. Video viewing will be assessed via a single yes/no survey item presented after the video. Results will be analyzed descriptively.

  2. Satisfaction with each intervention component (Acceptability)

    Time frame: Up to 1 year

    Acceptability is defined as majority satisfaction with each intervention component. Participants will be asked to rate their experience with the educational ACP video and ACP appointment on a 4-point Likert scale (e.g., very helpful, somewhat helpful, a little helpful, not helpful) using 4 questions regarding each intervention's usefulness and recommendations to peers. Higher scores indicate greater satisfaction and/or greater likelihood of recommending to peers. Descriptive statistics will be utilized to broadly analyze the sample.

Secondary outcomes

  1. Advance directive completion rates

    Time frame: Up to 1 year

    Assess by review of medical record to determine whether there was an increase in advance directive completion rates within the electronic medical record, as compared to historical institutional records (control). Descriptive statistics will be utilized to broadly analyze the sample.

  2. Change in ACP readiness

    Time frame: Baseline; 4 months; 7 months

    Assessed using 4 validated multiple-choice questions. Scores range from 0-20, with higher scores indicating increased readiness. In patients indicating that they signed official advance directive paperwork, an additional yes/no question will be asked to assess if any updates were made to advance directive documents (i.e. living will or surrogate decision maker/medical power of attorney) since that time. A mixed linear effect model will be used to analyze longitudinal changes.

  3. Change in ACP anxiety

    Time frame: Baseline; 4 months; 7 months

    Assessed using a single question on a 4-point Likert scale. A mixed linear effect model will be used to analyze longitudinal changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sey Oloyede

CONTACT

[email protected]

507-538-6811

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Empowerment Through Preparedness: Improving Advance Care Planning (ACP) in Adolescents and Young Adults (AYAs) With Advanced Solid Malignancies and High-Grade Brain Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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