Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03245411|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : December 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial (RCT) Single Center|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 20, 2017|
|Estimated Primary Completion Date :||December 20, 2022|
|Estimated Study Completion Date :||December 20, 2022|
No Intervention: Standard of Care (Control Group)
All participants in this group will receive the standard of care intervention provided by the RN.
Experimental: Intervention Group
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.
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.
- Adherence to oral chemotherapy [ Time Frame: 6 months ]Frequency of missed chemotherapy doses post randomization (based on interviews)
- Frequency of medication refills [ Time Frame: 6 months ]Prescription refills, based on pharmacy records
- Adherence to scheduled follow-up medical care visits [ Time Frame: 6 months ]Frequency and adherence to schedule follow up visit
- Healthcare utilization [ Time Frame: 6 months ]Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245411
|Contact: Claudia M Dourado, MD||215-456-3880||Douradoc@einstein.edu|
|Contact: Claudia Dourado||215-456-3880||Douradoc@einstein.edu|
|United States, Pennsylvania|
|Albert Einstein Healthcare Network||Recruiting|
|Philadelphia, Pennsylvania, United States, 19141|
|Contact: Claudia M Claudia M Dourado, MD 215-456-3880 DouradoC@einstein.edu|
|Contact: John C Leighton, MD 215-456-3880 firstname.lastname@example.org|
|Principal Investigator:||Claudia M Dourado, MD||Albert Einstein Healthcare Network|