CancerNCT05706610
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
A study testing Tailored Program and Feedback Program in people with Cancer and Adherence, Medication, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
Trial summary
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Cancer, Adherence, Medication
- What is being tested?
- Tailored Program and Feedback Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Feb 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient between 15 and 24 years of age
- Patient diagnosis of cancer
- Patient prescribed oral chemotherapy or prophylactic medication
Who cannot join
- Patient is not fluent in English
- Patient evidences significant cognitive deficits per medical team
- Patient's medical status or treatment precludes participation per medical team, patient, or caregiver
- Patient demonstrates greater than or equal to 95% adherence during run-in period
- Patient declines to use electronic monitoring device
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.
Read the detailed description
The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group.
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.
Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete post-treatment questionnaires regarding program usability and acceptability as well as their adherence.
- Conditions
- Cancer, Adherence, Medication
- Being tested
- Tailored Program, Feedback Program
- Keywords
- cancer, adherence
- Medical subject headings
- Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored ProgramBehavioural
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data.
Feedback ProgramBehavioural
Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Program | Experimental | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Receives: Behavioral: Tailored Program |
| Feedback Program | Other | 8-week feedback program including 8 weekly texts Receives: Behavioral: Feedback Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Percent of approached eligible participants enrolling in the study
Measured: End of study enrollment period, approximately 12 months after enrollment initiation
Secondary outcomes (11)
Retention Rate
The percent of participants completing all procedures for which they were eligible The numerator is calculated via the following formula: (n AYAs eligible to complete at least some study procedures [n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start] - n AYAs who never started study procedures - n AYAs who did not complete at least some study procedures) The denominator (n AYAs eligible to complete at least some study procedures) is calculated via the following formula: (n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start)
Measured: From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in)
Intervention Fidelity: Contact
Percent of participants randomized to the Tailored Program who completed 4 intervention sessions
Measured: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Length
Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length
Measured: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Duration
Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period
Measured: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Content
Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist
Measured: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Assessment Completion
Percent of enrolled participants with complete data
Measured: From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks)
System Usability Scale
A 10-item rating of usability, range = 0-100, better scores indicate better usability
Measured: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
"Adjective Rating Scale" (Measure of Usability)
1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability
Measured: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater
Rating of behavioral treatment acceptability - "I would recommend this program to other adolescents and young adults"; Possible range = 1 (strongly disagree) - 5 (strongly agree), better scores represent better acceptability; Dichotomous variable created representing whether participants scored this item as 1-3 (not acceptable) or 4-5 (acceptable)
Measured: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Medical Adherence Measure
1-item self-report of missed doses
Measured: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Electronically Monitored Medication Adherence
Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.
Measured: Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start23 Feb 2023
- Primary completion30 Nov 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Seattle Children's Hospital, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Meghan E McGrady, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706610
- Sponsor's protocol ID
- R21CA268945
- Status last verified
- Oct 2025
- First submitted
- 11 Jan 2023
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGrady ME, Ketterl TG, Webster RT, Burns MMK, Bills SE, Burke M, Szulczewski L, Brock MY, Schwartz LE, Herriott JK, Hommel KA, Pai ALH, Mara CA, Norris RE. Feasibility Trial of a Tailored Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer. Pediatr Blood Cancer. 2026 Jan;73(1):e32127. doi: 10.1002/pbc.32127. Epub 2025 Oct 27.
PubMed 41146444McGrady ME, Ketterl TG, Webster RT, Schwartz LE, Brock MY, Szulczewski L, Burke M, Hommel KA, Pai ALH, Mara CA, Steele AC, Regan GG, Norris RE. Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol. Contemp Clin Trials. 2024 Apr;139:107483. doi: 10.1016/j.cct.2024.107483. Epub 2024 Feb 29.
PubMed 38431133
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT05706610
- Acronym / sponsor ID
- R21CA268945
- Conditions
- Cancer, Adherence, Medication
- Keywords
- cancer, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Seattle Children's Hospital, University of Cincinnati
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.
Detailed description
The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group.
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.
Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete post-treatment questionnaires regarding program usability and acceptability as well as their adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Program | Experimental | Behavioral: Tailored Program8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins |
| Feedback Program | Other | Behavioral: Feedback Program8-week feedback program including 8 weekly texts |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient between 15 and 24 years of age
- Patient diagnosis of cancer
- Patient prescribed oral chemotherapy or prophylactic medication
Key exclusion criteria (5 listed)
- Patient is not fluent in English
- Patient evidences significant cognitive deficits per medical team
- Patient's medical status or treatment precludes participation per medical team, patient, or caregiver
- Patient demonstrates greater than or equal to 95% adherence during run-in period
- Patient declines to use electronic monitoring device
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 |
|---|---|---|
| Tailored ProgramParticipants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | Behavioural | Tailored Program |
| Feedback ProgramParticipants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. | Behavioural | Feedback Program |
Primary outcome
Enrollment Rate
Time frame: End of study enrollment period, approximately 12 months after enrollment initiation
Percent of approached eligible participants enrolling in the study
11 secondary outcomes
Retention Rate
Time frame: From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in)
Intervention Fidelity: Contact
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Length
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Duration
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Content
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Assessment Completion
Time frame: From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks)
System Usability Scale
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
"Adjective Rating Scale" (Measure of Usability)
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Medical Adherence Measure
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Electronically Monitored Medication Adherence
Time frame: Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41146444McGrady ME, Ketterl TG, Webster RT, Burns MMK, Bills SE, Burke M, Szulczewski L, Brock MY, Schwartz LE, Herriott JK, Hommel KA, Pai ALH, Mara CA, Norris RE. Feasibility Trial of a Tailored Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer. Pediatr Blood Cancer. 2026 Jan;73(1):e32127. doi: 10.1002/pbc.32127. Epub 2025 Oct 27.
- Derived from this study: PubMed 38431133McGrady ME, Ketterl TG, Webster RT, Schwartz LE, Brock MY, Szulczewski L, Burke M, Hommel KA, Pai ALH, Mara CA, Steele AC, Regan GG, Norris RE. Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol. Contemp Clin Trials. 2024 Apr;139:107483. doi: 10.1016/j.cct.2024.107483. Epub 2024 Feb 29.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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. This study is not recruiting at the moment.
Meghan E McGrady, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Program and Feedback Program in people with Cancer and Adherence, Medication, run by Children's Hospital Medical Center, Cincinnati at 3 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: End of study enrollment period, approximately 12 months after enrollment initiation). 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 NCT05706610, which also lists 2 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 2 Dec 2025.