CClinicalTrials.gg
Not yet recruitingNCT07865013Updated Oct 8, 2026

AYA Cancer Transitions Program

An interventional study of Transitions Program in Cancer, Cancer Survivorship and Adolescent and Young Adult Cancer Survivors, sponsored by University of Kansas Medical Center. Not yet recruiting. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Supportive care

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 24 Years
Sex
All
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Study 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. 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
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Conditions studied

  • Cancer
  • Cancer Survivorship
  • Adolescent and Young Adult Cancer Survivors
  • Transitions of Care

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Keywords

  • Cancer
  • Adolescent
  • Young Adult
  • AYA
  • Transitions of care
  • Cancer Survivorship
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 484 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18-24 years of age at recruitment
  2. Referral to adult survivorship clinic
  3. Primary cancer diagnosis occurred at age 21 years or younger
  4. English language proficiency.

Exclusion criteria

Exclusion Criteria:

Undergoing active treatment for cancer or recurrence

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Transitions Program

    Participants will receive: 1. A pre-transition developmental needs assessment 2. Up to 2 years of AYA nurse navigation support

    Behavioral: Transitions Program

Interventions

  • BehavioralTransitions Program

    Participants will receive: 1. A pre-transition developmental needs assessment 2. Up to 2 years of AYA nurse navigation support

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What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

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

07

Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865013
Lead sponsor
University of Kansas Medical Center
Responsible party
Carolyn Bates, PhD (Assistant Professor, Pediatrics, University of Kansas Medical Center) — Principal investigator
First posted
Oct 8, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 8, 2026

Study contacts

Carolyn Bates, PhD
Contact
cbates4@kumc.edu
913-588-6323
Kari Streumph, PhD
Contact
kstruemph@kumc.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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