Solid TumorNCT06989489
Implementation of an Oral Chemotherapy Adherence Intervention
A study testing Multilevel Adherence Intervention in people with Solid Tumor and Hematologic Malignancy, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Solid Tumor, Hematologic Malignancy
- What is being tested?
- Multilevel Adherence Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to 30 Aug 2028
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥21 years-old) patients
- Diagnosed with a solid or hematologic malignancy
- Monotherapy on oral anticancer agent on treatment for at least 6 months
Who cannot join
- Patients on time-limited or intermittent therapy (non-continuous)
- Patients on comfort (end-of-life) care
- Patients enrolled on hospice
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
UNC Chapel Hill
Chapel Hill, North Carolina, 27516
Benyam Muluneh, 919-962-0070, bmuluneh@unch.unc.edu
Bethel Belayneh, bdbelay@ad.unc.edu
About this study
Official title: Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention
The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). The study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months.
This study will have two groups of participants, a pre- and post-implementation group. In the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. Similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. These patients will be administered the same survey. The results from both groups will be analyzed to see how effective the medication adherence program is.
Read the detailed description
Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. The pharmacists will review with all their patients, information including proper administration, side effects, symptom management, and treatment plans. Participants will continue to have these counseling sessions with their pharmacists, until the patient becomes stable on the oral anticancer agent.
Once stable, the participant will be placed into one of three monitoring risk categories (low risk, medium risk, high risk), by the pharmacist, based on several factors. Each of the three monitor categories will have different monitoring intervals where patients will interact with the pharmacists differently. Additionally, each patient will have follow-up appointments and will have access to further education and will be reassessed each time. Furthermore, additional help will be provided to each patient based on their needs. Depending on the monitoring category, participants may meet with their pharmacist more and communicate either through electronic surveys or in-person visits.
- Conditions
- Solid Tumor, Hematologic Malignancy
- Being tested
- Multilevel Adherence Intervention
- Keywords
- oral anticancer agent, oral chemotherapy, adherence
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Adherence InterventionBehavioural
Also called Multicomponent Adherence Intervention
Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent based on their risk-stratified monitoring category. Participants will be followed longitudinally and will receive tailored support.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care patients | No intervention | Clinical pharmacists will follow their specific standards of procedure when educating patients on oral anticancer agents. No longitudinal following or tailored patient support will be provided. This group of participants will serve as the control group of the study. |
| Intervention participants | Experimental | Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. Participants will be followed longitudinally and will receive tailored support. Receives: Behavioral: Multilevel Adherence Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Medication Adherence
Patient's medication adherence of their oral anticancer regiment will be quantified using the PROMIS- medication adherence Likert-type questionnaire, from strongly disagree to strongly agree. Score will change from 1 to 5, with a maximum of 50 and minimum of 10. A higher score reflects better adherence. These answers will help the investigators see if the program was effective in helping the patient's medication adherence.
Measured: Baseline and week 4
Acceptability
A study specific survey will be used to measure acceptability. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better acceptance. Clinicians and administrators will answer the survey to capture their acceptability of the various aspects of the intervention.
Measured: After 6 months
Appropriateness
A study specific survey will be used to measure appropriateness. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better appropriateness. the survey will capture how well the clinicians and administrators graded the various aspects of the intervention.
Measured: After 6 months
Everyday use
A study specific survey will be used to measure how applicable for everyday use. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better everyday use. The survey will capture how easy the intervention is for clinicians and administrators.
Measured: After 6 months
Secondary outcomes (5)
Medication knowledge
A study specific survey that includes Likert-types and open-ended questions assessing the participant's knowledge on their medication and treatment will be used. Likert-style questions from strongly disagree to strongly agree with scores ranging from 1 to 5. Higher scores will reflect better knowledge of the participant's medication.
Measured: Baseline and 4 weeks
Patient perception
A study specific survey that will include Likert-type questions assessing the participant's perceptions of their cancer care team will be used. Likert-style questions from strongly disagree to strongly agree with scores ranging from 1 to 5. Higher scores will reflect better perceptions of the participants cancer care provider, providers in general, and all people who work in healthcare.
Measured: Baseline and 4 weeks
Health literacy
A study specific survey that will include Likert-type questions assessing the participant's health literacy of the instructions of their medication, treatment plan, healthcare professional explanations, and provider education will be used. Likert-style questions will range from not difficult to extremely difficult and scores ranging from 1 to 5. Higher scores will reflect stronger health literacy of the participants.
Measured: Baseline and 4 weeks
Self-efficacy
A study specific survey will consist of multiple-choice questions regarding resources participants use to help them take their medications as well as a Likert-style question, from strongly disagree to strongly agree about how and when to call a pharmacist. Likert-style questions will have scores ranging from 1 to 5. Higher scores will reflect better self-efficacy of the participants.
Measured: Baseline and 4 weeks
Patient satisfaction
A study specific survey will consist of Likert-style questions, ranging from strongly disagree to strongly agree, regarding the participant's satisfaction of their healthcare team, pharmacy team, care coordination, treatment plan, and education received since starting treatment will be used. Likert-style questions will have scores ranging from 1 to 5. Higher scores will reflect stronger satisfaction of the participants.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start28 May 2025
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Surveys will be administered to two different groups, before implementation and after implementation of intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Benyam Muluneh, PharmD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989489
- Sponsor's protocol ID
- LCCC2125-AIM3
- Other IDs
- K08CA279500
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention
- ClinicalTrials.gov ID
- NCT06989489
- Acronym / sponsor ID
- LCCC2125-AIM3
- Conditions
- Solid Tumor, Hematologic Malignancy
- Keywords
- oral anticancer agent, oral chemotherapy, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 25 May 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.
The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). The study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months.
This study will have two groups of participants, a pre- and post-implementation group. In the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. Similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. These patients will be administered the same survey. The results from both groups will be analyzed to see how effective the medication adherence program is.
Detailed description
Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. The pharmacists will review with all their patients, information including proper administration, side effects, symptom management, and treatment plans. Participants will continue to have these counseling sessions with their pharmacists, until the patient becomes stable on the oral anticancer agent.
Once stable, the participant will be placed into one of three monitoring risk categories (low risk, medium risk, high risk), by the pharmacist, based on several factors. Each of the three monitor categories will have different monitoring intervals where patients will interact with the pharmacists differently. Additionally, each patient will have follow-up appointments and will have access to further education and will be reassessed each time. Furthermore, additional help will be provided to each patient based on their needs. Depending on the monitoring category, participants may meet with their pharmacist more and communicate either through electronic surveys or in-person visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Surveys will be administered to two different groups, before implementation and after implementation of intervention.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care patients | No intervention | –Clinical pharmacists will follow their specific standards of procedure when educating patients on oral anticancer agents. No longitudinal following or tailored patient support will be provided. This group of participants will serve as the control group of the study. |
| Intervention participants | Experimental | Behavioral: Multilevel Adherence InterventionParticipants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. Participants will be followed longitudinally and will receive tailored support. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age ≥21 years-old) patients
- Diagnosed with a solid or hematologic malignancy
- Monotherapy on oral anticancer agent on treatment for at least 6 months
Key exclusion criteria (3 listed)
- Patients on time-limited or intermittent therapy (non-continuous)
- Patients on comfort (end-of-life) care
- Patients enrolled 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 |
|---|---|---|
| Multilevel Adherence InterventionAlso: Multicomponent Adherence InterventionParticipants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent based on their risk-stratified monitoring category. Participants will be followed longitudinally and will receive tailored support. | Behavioural | Intervention participants |
Primary outcome
Oral Medication Adherence
Time frame: Baseline and week 4
Patient's medication adherence of their oral anticancer regiment will be quantified using the PROMIS- medication adherence Likert-type questionnaire, from strongly disagree to strongly agree. Score will change from 1 to 5, with a maximum of 50 and minimum of 10. A higher score reflects better adherence. These answers will help the investigators see if the program was effective in helping the patient's medication adherence.
Acceptability
Time frame: After 6 months
A study specific survey will be used to measure acceptability. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better acceptance. Clinicians and administrators will answer the survey to capture their acceptability of the various aspects of the intervention.
Appropriateness
Time frame: After 6 months
A study specific survey will be used to measure appropriateness. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better appropriateness. the survey will capture how well the clinicians and administrators graded the various aspects of the intervention.
Everyday use
Time frame: After 6 months
A study specific survey will be used to measure how applicable for everyday use. Survey will have Likert-type questions, 1-5 strongly disagree to strongly agree, a higher score reflects better everyday use. The survey will capture how easy the intervention is for clinicians and administrators.
5 secondary outcomes
Medication knowledge
Time frame: Baseline and 4 weeks
Patient perception
Time frame: Baseline and 4 weeks
Health literacy
Time frame: Baseline and 4 weeks
Self-efficacy
Time frame: Baseline and 4 weeks
Patient satisfaction
Time frame: Baseline and 4 weeks
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.
- Clinical trials at UNC LinebergerLink 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.
Benyam Muluneh, PharmD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Adherence Intervention in people with Solid Tumor and Hematologic Malignancy, run by UNC Lineberger Comprehensive Cancer Center 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 3 inclusion and 3 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 Solomon Ayehu, MD (9196722032, solsay@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Medication Adherence (time frame: Baseline and week 4). The study lists 4 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.