Advanced Malignant Solid NeoplasmNCT07174661
Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid Tumors and High-Grade Brain Tumors
A study testing Advance Care Planning, Educational Intervention and Electronic Health Record Review in people with Advanced Malignant Solid Neoplasm and Malignant Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Malignant Brain Neoplasm, Recurrent Advanced Malignant Solid Neoplasm
- What is being tested?
- Advance Care Planning, Educational Intervention and Electronic Health Record Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Sey Oloyede, 507-538-6811, oloyede.oluwaseyitan@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Empowerment Through Preparedness: Improving Advance Care Planning (ACP) in Adolescents and Young Adults (AYAs) With Advanced Solid Malignancies 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.
- Conditions
- Advanced Malignant Solid Neoplasm, Malignant Brain Neoplasm, Recurrent Advanced Malignant Solid Neoplasm
- Being tested
- Advance Care Planning, Educational Intervention, Electronic Health Record Review, Survey Administration
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care PlanningBehavioural
Attend ACP appointment
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Watch on-demand early ACP educational video
Electronic Health Record ReviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Advance Care Planning; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (3)
Advance directive completion rates
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.
Measured: Up to 1 year
Change in ACP readiness
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.
Measured: Baseline; 4 months; 7 months
Change in ACP anxiety
Assessed using a single question on a 4-point Likert scale. A mixed linear effect model will be used to analyze longitudinal changes.
Measured: Baseline; 4 months; 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start2 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison C. Rosenthal, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174661
- Sponsor's protocol ID
- 25-007280
- Other IDs
- NCI-2025-06307, 25-007280
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowerment Through Preparedness: Improving Advance Care Planning (ACP) in Adolescents and Young Adults (AYAs) With Advanced Solid Malignancies and High-Grade Brain Tumors
- ClinicalTrials.gov ID
- NCT07174661
- Acronym / sponsor ID
- 25-007280
- Conditions
- Advanced Malignant Solid Neoplasm, Malignant Brain Neoplasm, Recurrent Advanced Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (early ACP) | Experimental | Behavioral: Advance Care Planning, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Those who have completed prior advanced directive documents are still eligible to participate.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care PlanningAttend ACP appointment | Behavioural | Supportive care (early ACP) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalWatch on-demand early ACP educational video | Other | Supportive care (early ACP) |
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (early ACP) |
| Survey AdministrationAncillary studies | Other | Supportive care (early ACP) |
Primary outcome
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.
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.
3 secondary outcomes
Advance directive completion rates
Time frame: Up to 1 year
Change in ACP readiness
Time frame: Baseline; 4 months; 7 months
Change in ACP anxiety
Time frame: Baseline; 4 months; 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison C. Rosenthal, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning, Educational Intervention and Electronic Health Record Review in people with Advanced Malignant Solid Neoplasm and Malignant Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sey Oloyede (507-538-6811, oloyede.oluwaseyitan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing routine, early Advance Care Planning (ACP) (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.