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CancerNCT07865013

AYA Cancer Transitions Program

A study testing Transitions Program in people with Cancer and Cancer Survivorship, run by University of Kansas Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single-arm, minimal-risk, interventional behavioral clinical trial embedding structured transition support for adolescent and young adult (AYA) survivors of pediatric cancer transitioning into adult-focused survivorship care. Read more about this study

Who is it for?
Ages 18 to 24 years
What is being tested?
Transitions Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Jan 2027to Dec 2030
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 24 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18-24 years of age at recruitment
  • Referral to adult survivorship clinic
  • Primary cancer diagnosis occurred at age 21 years or younger
  • English language proficiency.

Who cannot join

  • Undergoing active treatment for cancer or recurrence

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Carolyn Bates, PhD contact

913-588-6323

cbates4@kumc.edu

Kari Streumph, PhD contact

kstruemph@kumc.edu

About this study

This is a single-arm, minimal-risk, interventional behavioral clinical trial embedding structured transition support for adolescent and young adult (AYA) survivors of pediatric cancer transitioning into adult-focused survivorship care. Aims are to improve AYA transition from pediatric to adult survivorship care and to enhance AYA access to fertility education and care.

Patient Participants will:

  1. Complete a pre-transition developmental needs assessment
  2. Receive up to 2 years of AYA nurse navigation support
Being tested
Transitions Program
Keywords
Cancer, Adolescent, Young Adult, AYA, Transitions of care, Cancer Survivorship
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transitions ProgramBehavioural

    Participants will receive:

    1. A pre-transition developmental needs assessment
    2. Up to 2 years of AYA nurse navigation support
Study groups in NCT07865013
Study groupRoleWhat they receive
Transitions ProgramExperimentalParticipants will receive: 1. A pre-transition developmental needs assessment 2. Up to 2 years of AYA nurse navigation support
Receives: Behavioral: Transitions Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome is transition success (Goal: 80% of referred)

    Medical record abstraction will be used to collect detailed information on each participant's cancer history and follow-up care. This process will include extraction of key clinical data such as cancer diagnosis, dates of treatment, treatment location, and specific treatment modalities, including radiation and chemotherapy doses. Additional information on relapse history, occurrence of secondary malignancies, and adherence to COG screening recommendations will also be obtained. Data on subspecialty referrals, scheduled appointment dates, and attendance at those appointments will be recorded to assess patterns of care and follow-up.

    Measured: Medical record abstraction at baseline and annually for 3 years.

Secondary outcomes (7)

  1. Adolescent and young adult engagement and feedback

    Semi-structured interviews with AYA patients will collect qualitative feedback focused on feasibility, acceptability, and utility of the program. For AYAs who do not participate in the program, interviews will inquire about barriers or reasons for non-participation.

    Interviews will focus on the following core topics: overall experience with pre-transition assessment and navigation, clarity and relevance of information provided, access to recommended resources and barriers, fertility education experience and referrals, self-management and transition readiness changes, suggestions to improve the program, and preferred mode/timing of contacts.

    Measured: Assessed by structured interviews at 18 & 36 mo.

  2. Adherence to Children's Oncology Group (COG) survivorship guidelines.

    Medical record abstraction will be used to collect detailed information on each participant's cancer history and follow-up care. This process will include extraction of key clinical data such as cancer diagnosis, dates of treatment, treatment location, and specific treatment modalities, including radiation and chemotherapy doses. Additional information on relapse history, occurrence of secondary malignancies, and adherence to COG screening recommendations will also be obtained. Data on subspecialty referrals, scheduled appointment dates, and attendance at those appointments will be recorded to assess patterns of care and follow-up.

    Measured: Will be assessed by medical record abstraction at baseline, and annually for 3 years.

  3. Demographic and diversity-related factors of representation

    The Behavioral Measurement-Based Care in Psychiatry (BMCP) Diversity Dimensions Measurement Tool is a checklist assessing demographic and diversity-related factors to examine representation. After baseline, we will shorten this measure by only including demographic factors that have potential to change over time.

    Measured: Will be assessed at baseline and years 1-3.

  4. Transition Readiness

    The Transition Readiness Assessment Questionnaire (TRAQ13) is a questionnaire assessing preparedness for transition to adult healthcare.

    Measured: Will be measured at baseline and years 1-3.

  5. Health-Related Quality of Life

    National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 is a tool to measure health-related quality of life.

    Measured: Will be measured at baseline and years 1-3.

  6. Reproductive Concerns

    The Reproductive Concerns after Cancer (RCAC) scale is an instrument used to measure concerns regarding fertility and parenthood among AYA cancer survivors.

    Measured: Will be measured at baseline and years 1-3.

  7. Economic Impact of Illness

    COST-FACIT instrument quantifies the economic impact of illness from a patient's perspective (particularly in cancer care).

    Measured: Will be measured at baseline and years 1-3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865013
Sponsor's protocol ID
STUDY00162219
Status last verified
Oct 2026
First submitted
17 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gorman JR, Drizin JH, Malcarne VL, Hsieh TC. Measuring the Multidimensional Reproductive Concerns of Young Adult Male Cancer Survivors. J Adolesc Young Adult Oncol. 2020 Dec;9(6):613-620. doi: 10.1089/jayao.2019.0146. Epub 2020 Apr 16.

    PubMed 32298593

  • Quinn GP, Bowman Curci M, Reich RR, Gwede CK, Meade CD; ENRICH/ECHO Working Group; Vadaparampil ST. Impact of a web-based reproductive health training program: ENRICH (Educating Nurses about Reproductive Issues in Cancer Healthcare). Psychooncology. 2019 May;28(5):1096-1101. doi: 10.1002/pon.5063. Epub 2019 Apr 5.

    PubMed 30882960

  • de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.

    PubMed 27716900

  • Siembida EJ, Reeve BB, Zebrack BJ, Snyder MA, Salsman JM. Measuring health-related quality of life in adolescent and young adult cancer survivors with the National Institutes of Health Patient-Reported Outcomes Measurement Information System(R) : Comparing adolescent, emerging adult, and young adult survivor perspectives. Psychooncology. 2021 Mar;30(3):303-311. doi: 10.1002/pon.5577. Epub 2020 Oct 30.

    PubMed 33073416

  • Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

    PubMed 20685078

  • Otth M, Denzler S, Koenig C, Koehler H, Scheinemann K. Transition from pediatric to adult follow-up care in childhood cancer survivors-a systematic review. J Cancer Surviv. 2021 Feb;15(1):151-162. doi: 10.1007/s11764-020-00920-9. Epub 2020 Jul 16.

    PubMed 32676793

  • Ehrhardt MJ, Friedman DN, Hudson MM. Health Care Transitions Among Adolescents and Young Adults With Cancer. J Clin Oncol. 2024 Feb 20;42(6):743-754. doi: 10.1200/JCO.23.01504. Epub 2024 Jan 9.

    PubMed 38194608

  • Marchak JG, Sadak KT, Effinger KE, Haardorfer R, Escoffery C, Kinahan KE, Freyer DR, Chow EJ, Mertens A. Transition practices for survivors of childhood cancer: a report from the Children's Oncology Group. J Cancer Surviv. 2023 Apr;17(2):342-350. doi: 10.1007/s11764-023-01351-y. Epub 2023 Mar 4.

    PubMed 36870037

  • Hudson MM, Bhatia S, Casillas J, Landier W; SECTION ON HEMATOLOGY/ONCOLOGY, CHILDREN'S ONCOLOGY GROUP, AMERICAN SOCIETY OF PEDIATRIC HEMATOLOGY/ONCOLOGY. Long-term Follow-up Care for Childhood, Adolescent, and Young Adult Cancer Survivors. Pediatrics. 2021 Sep;148(3):e2021053127. doi: 10.1542/peds.2021-053127.

    PubMed 34462344

  • Landier W, Armenian S, Bhatia S. Late effects of childhood cancer and its treatment. Pediatr Clin North Am. 2015 Feb;62(1):275-300. doi: 10.1016/j.pcl.2014.09.017. Epub 2014 Oct 18.

    PubMed 25435123

  • Robison LL, Armstrong GT, Boice JD, Chow EJ, Davies SM, Donaldson SS, Green DM, Hammond S, Meadows AT, Mertens AC, Mulvihill JJ, Nathan PC, Neglia JP, Packer RJ, Rajaraman P, Sklar CA, Stovall M, Strong LC, Yasui Y, Zeltzer LK. The Childhood Cancer Survivor Study: a National Cancer Institute-supported resource for outcome and intervention research. J Clin Oncol. 2009 May 10;27(14):2308-18. doi: 10.1200/JCO.2009.22.3339. Epub 2009 Apr 13.

    PubMed 19364948

  • Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185.

    PubMed 17035650

Questions about this trial

What is this clinical trial studying?

A study testing Transitions Program in people with Cancer and Cancer Survivorship, run by University of Kansas Medical Center.

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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Carolyn Bates, PhD (913-588-6323, cbates4@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome is transition success (Goal: 80% of referred) (time frame: Medical record abstraction at baseline and annually for 3 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07865013, which also lists 12 linked publications.

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 Oct 2026.

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