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

NCT07174661 | Recruiting

• 2 other identifiers: 25-007280NCI-2025-06307
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Brain Neoplasm; Recurrent Advanced Malignant Solid Neoplasm; Advanced Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

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

  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.

  Up to 1 year

• Satisfaction with each intervention component (Acceptability)

  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.

  Up to 1 year

Secondary Outcomes (3)

• Advance directive completion rates

  Up to 1 year

• Change in ACP readiness

  Baseline; 4 months; 7 months

• Change in ACP anxiety

  Baseline; 4 months; 7 months

Study Arms (1)

Supportive care (early ACP)

EXPERIMENTAL

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.

Behavioral: Advance Care Planning; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Educational Intervention OTHER

Watch on-demand early ACP educational video

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (early ACP)

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (early ACP)

Survey Administration OTHER

Ancillary studies

Supportive care (early ACP)

Advance Care Planning BEHAVIORAL

Attend ACP appointment

Supportive care (early ACP)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 advance directive documents are still eligible to participate.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Advance Care Planning; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Allison C. Rosenthal, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sey Oloyede

CONTACT

507-538-6811; oloyede.oluwaseyitan@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)