CancerNCT03245411
Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients
A study testing Intervention in people with Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The majority of patients have a diverse cultural background, low literacy, and poor social-economic status. Medication adherence for chronic medical problems is in a range of 40-70%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 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
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients on oral chemotherapeutic agents
- Clinical diagnosis of stage IV breast cancer
- Clinical diagnosis of stage III and IV colorectal cancer (not receiving concurrent radiation therapy)
- Clinical diagnosis of stage IV non-small cell lung cancer
- Clinical diagnosis of stage IV renal cell carcinoma
- Clinical diagnosis of stage IV ovarian carcinoma
Show all 17Show fewer
- Clinical diagnosis of multiple myeloma
- Clinical diagnosis of chronic myelogenous leukemia on TKI
- Clinical diagnosis of myelodysplastic syndrome on Lenalidomide
- Adjuvant treatment for Gastro Intestinal Stromal Tumor
- Clinical diagnosis of chronic Lymphocytic Leukemia
- Clinical diagnosis of metastatic Prostate cancer
- Clinical diagnosis of hepatocellular Carcinoma
- Clinical diagnosis of stage IV Melanoma
- Clinical diagnosis of myelofibrosis/myeloproliferative neoplasms
- Age >18 years
- ECOG Performance Status <3
Who cannot join
- ECOG Performance Status of 3 and above
- Concurrent chemo radiation
- Non-English speaker
- Clinical diagnosis of dementia, or otherwise unable to give informed consent.
- History of non-compliance (defined as the history of 2 or more missed appointments in the clinic).
- Pregnant patients
- Nursing Home Patients
- Incarcerated
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
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Claudia M Claudia M Dourado, MD, 215-456-3880, DouradoC@einstein.edu
John C Leighton, MD, 215-456-3880, leightoj@einstein.edu
About this study
Official title: A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community
Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The majority of patients have a diverse cultural background, low literacy, and poor social-economic status. Medication adherence for chronic medical problems is in a range of 40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in detail. The main objective is to study medication adherence to oral anticancer agents in patients with low literacy and poor socio-economic status.
Read the detailed description
Until recently, contemporary approaches to cancer care have failed to consistently tailor communication approaches to patients with low health literacy. They have produced mixed results in regard to implementation of successful interventions in addressing the needs of this populations. Low health literacy is especially common in medically underserved communities, including in North Philadelphia. Cancer treatment, including cancer chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere to care and achieve the goals of therapy. Patients with low health literacy find it especially challenging to navigate cancer treatment. Results of previous research showed that intervention strategies that address the needs for information and material support of African American older adults, can help improve adherence to cancer screening in this population.
The purpose is to develop and evaluate model interventions to improve healthcare outcomes for socially disadvantaged populations. The objective in this proposal is to conduct a randomized controlled trial that evaluates the effects of an intervention that provides enhanced education and material support, on adherence to care, among the cancer patients of the Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.
The central hypothesis is that compared to the standard educational intervention delivered by a registered nurse, the addition of an enhanced intervention (enhanced education, problem-solving skills and facilitative support) will result in greater adherence care, especially among patients with low health literacy.
- Conditions
- Cancer
- Being tested
- Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
All participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Control Group) | No intervention | All participants in this group will receive the standard of care intervention provided by the RN. |
| Intervention Group | Experimental | In addition to the standard of care, the participants randomized to Intervention Group will be invited to a separate room. The following activities will be undertaken, in order to address patients' questions and concerns, and discuss potential solutions to their barriers to care
The patient will be asked to watch brief educational videos on "Life with oral cancer treatment." The information contained in the videos will be reinforced with materials written at a 4th grade level, that correspond to each of the brief videos.The patient will receive a brief phone call (from the study coordinator) on the first business day following the baseline interview, and thereafter, two weeks following each visit to the oncology clinic. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to oral chemotherapy
Frequency of missed chemotherapy doses post randomization (based on interviews)
Measured: 6 months
Secondary outcomes (3)
Frequency of medication refills
Prescription refills, based on pharmacy records
Measured: 6 months
Adherence to scheduled follow-up medical care visits
Frequency and adherence to schedule follow up visit
Measured: 6 months
Healthcare utilization
Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start20 Jul 2017
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (RCT) Single Center
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Claudia M Dourado, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245411
- Sponsor's protocol ID
- 4950
- Other IDs
- JT 27684
- Status last verified
- May 2026
- First submitted
- 2 Aug 2017
- Last updated
- 29 May 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community
- ClinicalTrials.gov ID
- NCT03245411
- Acronym / sponsor ID
- 4950
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Aug 2017 (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.
Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The majority of patients have a diverse cultural background, low literacy, and poor social-economic status. Medication adherence for chronic medical problems is in a range of 40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in detail. The main objective is to study medication adherence to oral anticancer agents in patients with low literacy and poor socio-economic status.
Detailed description
Until recently, contemporary approaches to cancer care have failed to consistently tailor communication approaches to patients with low health literacy. They have produced mixed results in regard to implementation of successful interventions in addressing the needs of this populations. Low health literacy is especially common in medically underserved communities, including in North Philadelphia. Cancer treatment, including cancer chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere to care and achieve the goals of therapy. Patients with low health literacy find it especially challenging to navigate cancer treatment. Results of previous research showed that intervention strategies that address the needs for information and material support of African American older adults, can help improve adherence to cancer screening in this population.
The purpose is to develop and evaluate model interventions to improve healthcare outcomes for socially disadvantaged populations. The objective in this proposal is to conduct a randomized controlled trial that evaluates the effects of an intervention that provides enhanced education and material support, on adherence to care, among the cancer patients of the Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.
The central hypothesis is that compared to the standard educational intervention delivered by a registered nurse, the addition of an enhanced intervention (enhanced education, problem-solving skills and facilitative support) will result in greater adherence care, especially among patients with low health literacy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT) Single Center
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Control Group) | No intervention | –All participants in this group will receive the standard of care intervention provided by the RN. |
| Intervention Group | Experimental | Behavioral: InterventionIn addition to the standard of care, the participants randomized to Intervention Group will be invited to a separate room. The following activities will be undertaken, in order to address patients' questions and concerns, and discuss potential solutions to their barriers to care The patient will be asked to watch brief educational videos on "Life with oral cancer treatment." The information contained in the videos will be reinforced with materials written at a 4th grade level, that correspond to each of the brief videos.The patient will receive a brief phone call (from the study coordinator) on the first business day following the baseline interview, and thereafter, two weeks following each visit to the oncology clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All patients on oral chemotherapeutic agents
- Clinical diagnosis of stage IV breast cancer
- Clinical diagnosis of stage III and IV colorectal cancer (not receiving concurrent radiation therapy)
- Clinical diagnosis of stage IV non-small cell lung cancer
- Clinical diagnosis of stage IV renal cell carcinoma
Key exclusion criteria (8 listed)
- ECOG Performance Status of 3 and above
- Concurrent chemo radiation
- Non-English speaker
- Clinical diagnosis of dementia, or otherwise unable to give informed consent.
- History of non-compliance (defined as the history of 2 or more missed appointments in the clinic).
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 |
|---|---|---|
| InterventionAll participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated. | Behavioural | Intervention Group |
Primary outcome
Adherence to oral chemotherapy
Time frame: 6 months
Frequency of missed chemotherapy doses post randomization (based on interviews)
3 secondary outcomes
Frequency of medication refills
Time frame: 6 months
Adherence to scheduled follow-up medical care visits
Time frame: 6 months
Healthcare utilization
Time frame: 6 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 29 May 2026.
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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.
Claudia M Dourado, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cancer, run by Thomas Jefferson University 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 17 inclusion and 8 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 29 May 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 Claudia M Dourado, MD (215-456-3880, Douradoc@einstein.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to oral chemotherapy (time frame: 6 months). 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 29 May 2026.