Uno studio di diversi programmi per aiutare TUTTI i pazienti ad assumere farmaci di mantenimento a casa
Strategie di miglioramento dell'aderenza al 6MP basate sul rischio in bambini, adolescenti e giovani adulti affetti da LLA: uno studio pilota
This clinical trial tests different programs to help patients with acute lymphoblastic leukemia (ALL) remember to take their medications during maintenance therapy at home. One problem with ALL maintenance treatment is remembering to take medicines at home like patients are supposed to. In maintenance, a medicine called 6-mercaptopurine or "6MP" is taken by mouth every day at home. In this study, 6MP prescriptions are filled into a special medication bottle called MEMS® which is fitted with a special cap called TrackCap™ that electronically records when the medication bottle is opened. Researchers are trying a new program to help patients be better at taking their 6MP like they're supposed to. This new program may help patients to remember to take their 6MP medication.
Panoramica dello studio
Stato
Intervento / Trattamento
- Procedura: Biospecimen Collection
- Altro: Questionnaire Administration
- Droga: Mercaptopurine
- Altro: Informational Intervention
- Altro: Media Intervention
- Altro: Media Intervention
- Altro: Medical Device Usage and Evaluation
- Comportamentale: Training and Education
- Comportamentale: Compliance Monitoring
- Comportamentale: Compliance Monitoring
- Comportamentale: Telephone-Based Intervention
- Comportamentale: Telephone-Based Intervention
- Comportamentale: Telephone-Based Intervention
- Comportamentale: Telephone-Based Intervention
- Altro: Health Promotion and Education
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Collect data on the feasibility of a phase 3 adherence-enhancing 2 parallel 2-arm randomized clinical trial.
Ia. Estimate participation rates, refusal reasons, and attrition rates. Ib. Evaluate rates of completeness of all aspects of the study (surveys [rates of missing elements]; MEMS® TrackCap™ return rates; maintenance form return rates from site clinical research assistants [CRAs]; blood samples for pharmacogenetics and deoxyribonucleic acid [DNA]-incorporated thioguanine nucleotide [DNA-TG] levels).
SECONDARY OBJECTIVES:
I. Among baseline non-adherers, estimate the impact of ultra-intensified intervention package (U-iIP) versus (vs.) intervention package (IP) on 6MP adherence.
II. Among baseline adherers, estimate the impact of patient-empowered intervention package (pIP) vs. education alone (EDU) on 6MP adherence.
OUTLINE:
Patients receive the Patient Supply Kit containing an empty MEMS® medication bottle with TrackCap™ with child resistant medication bottles and child resistant standard caps, and written instructions for the patient and pharmacist, along with their 6MP prescription. Beginning on day 1 cycle 1 of Maintenance Therapy, patients start using the MEMS® medication bottle with TrackCap™. Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap™ is being used, to identify any obstacles, and to determine solutions. Patients are instructed to return the first MEMS® TrackCap™ to the clinic on day 1 of Maintenance cycle 2. Patients are then assigned to 1 of 2 groups based on baseline adherence rates (adherers [adherence rate >= 95%] and non-adherers [adherence rate < 95%]).
NON-ADHERERS: Patients are randomized to 1 of 2 arms during cycle 2 of Maintenance therapy.
ARM I (IP): Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the multimedia interactive patient/parent/other adult education (MIPE) program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. A designated parent/other adult is selected and trained briefly in prompting and supervising the patient to take 6MP daily by the CRA on day 1 of Maintenance cycle 3. Patients also receive customized printed medication schedules approximately every 4 weeks (days 1, 29, and 57) during Maintenance cycles 3-5 (during scheduled clinic visits) from their healthcare provider. Patients and/or the parent/other adult receive automated customized electronic reminders delivered via smartphone according to the patient's electronic 6MP schedule. Once the designated parent/other adult receives the customized electronic reminder for 6MP, they are instructed to prompt initiation of the 6MP dose (if necessary), and to supervise the ingestion of the prescribed 6MP (in all instances). If the patient is not present when the dose of 6MP is due, the patient receives a call from the designated parent/other adult to prompt initiation of the dose. Patients and designated parents/other adults will be instructed to electronically indicate when 6MP has been taken (indicative of directly supervised therapy [DST] execution). Additionally, patients undergo blood sample collection on the study.
ARM II (U-iIP): Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. A designated parent/other adult is selected and trained briefly in prompting and supervising the patient to take 6MP daily by the CRA on day 1 of Maintenance cycle 3. Patients also receive customized printed medication schedules approximately every 4 weeks (days 1, 29, and 57) during Maintenance cycles 3-5 (during scheduled clinic visits) from their healthcare provider. Patients and/or the parent/other adult receive automated customized electronic reminders delivered via smartphone according to the patient's electronic 6MP schedule. Once the designated parent/other adult receives the reminder for 6MP, they are instructed to prompt initiation of the 6MP dose (if necessary), and to supervise the ingestion of the prescribed 6MP (in all instances). If the patient is not present when the dose of 6MP is due, the patient receives a call from the designated parent/other adult to prompt initiation of the dose. Patients and designated parents/other adults will be instructed to electronically indicate when 6MP has been taken (indicative of DST execution). If there is no response by the designated parent/other adult indicating 6MP ingestion within 1 hour of the scheduled time, additional automated reminders are sent. The Adherence Study Coordinating Center will evaluate electronic responses (indicative of DST execution) every 4 weeks. The DST response rates will be communicated to the COG sites, identifying the patients as low DST responders (response rate: < 85%) or high DST responders (response rate: ≥ 85%), along with instructions to serve as a guideline for communicating these results when reviewing them with their patient. DST response rates will be reviewed with the patient every 4 weeks at the clinic visit by the healthcare provider for all U-iIP patients (irrespective of response rate). Patients (and their designated caregiver) receive booster MIPE videos to view on their smartphone every 4 weeks (Days 1, 29, and 57) during Maintenance cycles 3-5, with content that reinforces the importance of 6MP in treating leukemia, having a daily routine for 6MP ingestion, and executing/confirming directly supervised therapy (DST) with each dose, and review common barriers to 6MP ingestion and DST execution (e.g., patient away from home, change in daily schedule), address additional barriers significantly associated with DST execution, and feature examples of patients/other adults self-identifying barriers (e.g., parent not always home at time of 6MP, lack of organizational skills, etc.), and provide specific steps to overcome the barriers. Additionally, patients undergo blood sample collection on the study.
ADHERERS: Patients are randomized to 1 of 2 arms during cycle 2 of Maintenance therapy.
ARM III (EDU: Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
ARM IV (pIP): Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. On day 1 of Maintenance cycle 3, patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic. On day 1 of Maintenance cycle 3, the patient and a designated parent/other adult are trained to set daily reminders on their smartphones at the time the 6MP is due, and to use the "snooze" function to allow repeated reminders in case the medication cannot be taken when the alarm first goes off. The designated parent/other adult is also trained briefly by the CRA in prompting and supervising the patient to take 6MP daily. Once the designated parent/other adult hears the smartphone alarm for 6MP, they are instructed to prompt initiation of the 6MP dose (if necessary), and to supervise the ingestion of the prescribed 6MP (in all instances). If the patient is not present when the dose of 6MP is due, the patient receives a call from the designated parent/other adult to prompt initiation of the dose. Additionally, patients undergo blood sample collection on the study.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- Children's Hospital of Alabama
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-
Arkansas
-
Little Rock, Arkansas, Stati Uniti, 72202-3591
- Arkansas Children's Hospital
-
-
California
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Oakland, California, Stati Uniti, 94611
- Kaiser Permanente-Oakland
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-
Delaware
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Wilmington, Delaware, Stati Uniti, 19803
- Alfred I duPont Hospital for Children
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-
Florida
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Fort Myers, Florida, Stati Uniti, 33908
- Golisano Children's Hospital of Southwest Florida
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Jacksonville, Florida, Stati Uniti, 32207
- Nemours Children's Clinic-Jacksonville
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Orlando, Florida, Stati Uniti, 32827
- Nemours Children's Hospital
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Orlando, Florida, Stati Uniti, 32803
- AdventHealth Orlando
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Riley Hospital for Children
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Maine
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Bangor, Maine, Stati Uniti, 04401
- Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21215
- Sinai Hospital of Baltimore
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- C S Mott Children's Hospital
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, Stati Uniti, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, Stati Uniti, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Stati Uniti, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Stati Uniti, 89502
- Renown Regional Medical Center
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New York
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Buffalo, New York, Stati Uniti, 14263
- Roswell Park Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Children's Hospital of Philadelphia
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-
Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
-
-
South Carolina
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Columbia, South Carolina, Stati Uniti, 29203
- Prisma Health Richland Hospital
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Texas
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Austin, Texas, Stati Uniti, 78723
- Dell Children's Medical Center of Central Texas
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San Antonio, Texas, Stati Uniti, 78229
- Methodist Children's Hospital of South Texas
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Virginia
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Falls Church, Virginia, Stati Uniti, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, Stati Uniti, 23507
- Children's Hospital of The King's Daughters
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Washington
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Tacoma, Washington, Stati Uniti, 98431
- Madigan Army Medical Center
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age: >= 10 years and =< 25 years
- Previously enrolled onto AALL1732
- Consented to the AALL1732 mercaptopurine adherence correlative study
- Maintenance therapy has not yet begun
- English or Spanish-speaking (patient and parent/other adult)
- Planning to receive 6MP (as tablets) during maintenance phase of therapy
- Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
- Has a designated parent/other adult who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
- Patient/parent/other adult must be willing to use a smartphone to receive medication reminders
- Receiving treatment at a Children's Oncology Group (COG) institution in the United States
Exclusion Criteria:
-
Patients who have previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
-
Regulatory requirements
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study. |
Undergo blood sample collection
Altri nomi:
Ancillary studies Receive Patient Supply Kit View MIPE program videos Review booster MIPE videos Use MEMS® with TrackCap™ Undergo training for prompting and supervising 6MP |
|
Sperimentale: Adherers arm IV (pIP)
See Detailed Description. |
Undergo blood sample collection
Altri nomi:
Ancillary studies Given PO
Altri nomi:
Receive Patient Supply Kit View MIPE program videos Review booster MIPE videos Use MEMS® with TrackCap™ Undergo training for prompting and supervising 6MP Receive DST Healthcare provider reviews DST response rates with the patient and any challenges they are having with 6MP adherence every 4 weeks at clinic visits Receive automated customized electronic reminders via smartphone Receive additional automated reminders Manually activate daily smartphone reminders with successive alerts (using the "snooze" function) Receive electronic reminders with successive alerts (using the "snooze" function) |
|
Sperimentale: Non-adherers arm I (IP)
See Detailed Description. |
Undergo blood sample collection
Altri nomi:
Ancillary studies Given PO
Altri nomi:
Receive Patient Supply Kit View MIPE program videos Review booster MIPE videos Use MEMS® with TrackCap™ Undergo training for prompting and supervising 6MP Receive DST Healthcare provider reviews DST response rates with the patient and any challenges they are having with 6MP adherence every 4 weeks at clinic visits Receive automated customized electronic reminders via smartphone Receive additional automated reminders Manually activate daily smartphone reminders with successive alerts (using the "snooze" function) Receive electronic reminders with successive alerts (using the "snooze" function) Receive customized printed medication schedules |
|
Sperimentale: Non-adherers arm II (U-iIP)
See Detailed Description. |
Undergo blood sample collection
Altri nomi:
Ancillary studies Given PO
Altri nomi:
Receive Patient Supply Kit View MIPE program videos Review booster MIPE videos Use MEMS® with TrackCap™ Undergo training for prompting and supervising 6MP Receive DST Healthcare provider reviews DST response rates with the patient and any challenges they are having with 6MP adherence every 4 weeks at clinic visits Receive automated customized electronic reminders via smartphone Receive additional automated reminders Manually activate daily smartphone reminders with successive alerts (using the "snooze" function) Receive electronic reminders with successive alerts (using the "snooze" function) Receive customized printed medication schedules |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participation
Lasso di tempo: At baseline (by day 1 of maintenance chemotherapy)
|
Will calculate and report the proportion of patients eligible for the study who participate and will report a corresponding 95% confidence interval. |
At baseline (by day 1 of maintenance chemotherapy)
|
|
Refusal reasons
Lasso di tempo: At baseline (by day 1 of maintenance chemotherapy)
|
A single question in a study case report form prompts refusal reason. For each available reason, will calculate and report the proportion of patients reporting that refusal reason as well as corresponding 95% confidence intervals. |
At baseline (by day 1 of maintenance chemotherapy)
|
|
Attrition
Lasso di tempo: By 60 weeks from day 1 of maintenance chemotherapy
|
Will calculate and report the proportion of patients who drop out of the study prior to completion among those eligible and enrolled and will report the corresponding 95% confidence interval. |
By 60 weeks from day 1 of maintenance chemotherapy
|
|
Completion of study measures
Lasso di tempo: By 60 weeks from day 1 of maintenance chemotherapy
|
Will calculate and report the proportion of patients who complete the following measures by the end of the study follow-up period: study survey submission, MEMS® TrackCap™ return, maintenance form return, and blood sample submission. Will also report the corresponding 95% confidence intervals. |
By 60 weeks from day 1 of maintenance chemotherapy
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
6-mercaptopurine (6MP) adherence (baseline non-adherers)
Lasso di tempo: By 60 weeks from day 1 of maintenance chemotherapy
|
Among baseline non-adherers, the proportion of days with protocol defined appropriate medication use during the study follow up period will be captured for each patient using the MEMS cap. Will calculate and report the mean proportion of adherence days by arm and the corresponding 95% confidence interval. |
By 60 weeks from day 1 of maintenance chemotherapy
|
|
6MP adherence (baseline adherers)
Lasso di tempo: By 60 weeks from day 1 of maintenance chemotherapy
|
Among baseline adherers, protocol defined appropriate medication use during the study follow up period will be captured for each patient using the MEMS cap. Will calculate and report the proportion with >= 95% adherence over the study follow up period by arm with a corresponding 95% confidence interval. |
By 60 weeks from day 1 of maintenance chemotherapy
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Smita Bhatia, Children's Oncology Group
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Leucemia, linfoide
- Leucemia
- Malattie emiche e linfatiche
- Leucemia-linfoma linfoblastico a cellule precursori
- Composti di zolfo
- Prodotti chimici organici
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Tecniche investigative
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Purine
- Servizi sanitari
- Force di lavoro e servizi per le strutture sanitarie
- Servizi sanitari preventivi
- Fattori socioeconomici
- Caratteristiche della popolazione
- Composti solfidrilici
- Educazione sanitaria
- Mercaptopurina
- Stato educativo
- Gestione dei campioni
- azathiopurina
- Promozione della salute
Altri numeri di identificazione dello studio
- ACCL2433
- UG1CA189955 (Sovvenzione/contratto NIH degli Stati Uniti)
- ACCL2433 (Altro identificatore: CTEP)
- NCI-2024-08458 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- COG-ACCL2433 (Altro identificatore: DCP)
- ACCL2433 (Altro identificatore: Children's Oncology Group)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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