Eine Studie über verschiedene Programme, um ALLEN Patienten bei der Einnahme von Erhaltungsmedikamenten zu Hause zu helfen
Risikobasierte 6MP-Adhärenzverbesserungsstrategien bei Kindern, Jugendlichen und jungen Erwachsenen mit ALL – eine Pilotstudie
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.
Studienübersicht
Status
Intervention / Behandlung
- Verfahren: Biospecimen Collection
- Sonstiges: Questionnaire Administration
- Arzneimittel: Mercaptopurine
- Sonstiges: Informational Intervention
- Sonstiges: Media Intervention
- Sonstiges: Media Intervention
- Sonstiges: Medical Device Usage and Evaluation
- Verhalten: Training and Education
- Verhalten: Compliance Monitoring
- Verhalten: Compliance Monitoring
- Verhalten: Telephone-Based Intervention
- Verhalten: Telephone-Based Intervention
- Verhalten: Telephone-Based Intervention
- Verhalten: Telephone-Based Intervention
- Sonstiges: Health Promotion and Education
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Alabama
-
Birmingham, Alabama, Vereinigte Staaten, 35233
- Children's Hospital of Alabama
-
-
Arkansas
-
Little Rock, Arkansas, Vereinigte Staaten, 72202-3591
- Arkansas Children's Hospital
-
-
California
-
Oakland, California, Vereinigte Staaten, 94611
- Kaiser Permanente-Oakland
-
-
Delaware
-
Wilmington, Delaware, Vereinigte Staaten, 19803
- Alfred I duPont Hospital for Children
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-
Florida
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Fort Myers, Florida, Vereinigte Staaten, 33908
- Golisano Children's Hospital of Southwest Florida
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Jacksonville, Florida, Vereinigte Staaten, 32207
- Nemours Children's Clinic-Jacksonville
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Orlando, Florida, Vereinigte Staaten, 32827
- Nemours Children's Hospital
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Orlando, Florida, Vereinigte Staaten, 32803
- AdventHealth Orlando
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Riley Hospital for Children
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Maine
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Bangor, Maine, Vereinigte Staaten, 04401
- Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21215
- Sinai Hospital of Baltimore
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- C S Mott Children's Hospital
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, Vereinigte Staaten, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, Vereinigte Staaten, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Vereinigte Staaten, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Vereinigte Staaten, 89502
- Renown Regional Medical Center
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New York
-
Buffalo, New York, Vereinigte Staaten, 14263
- Roswell Park Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Children's Hospital of Philadelphia
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital
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South Carolina
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Columbia, South Carolina, Vereinigte Staaten, 29203
- Prisma Health Richland Hospital
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Texas
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Austin, Texas, Vereinigte Staaten, 78723
- Dell Children's Medical Center of Central Texas
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San Antonio, Texas, Vereinigte Staaten, 78229
- Methodist Children's Hospital of South Texas
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Virginia
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Falls Church, Virginia, Vereinigte Staaten, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, Vereinigte Staaten, 23507
- Children's Hospital of The King's Daughters
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Washington
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Tacoma, Washington, Vereinigte Staaten, 98431
- Madigan Army Medical Center
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Wisconsin
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Green Bay, Wisconsin, Vereinigte Staaten, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
Andere Namen:
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 |
|
Experimental: Adherers arm IV (pIP)
See Detailed Description. |
Undergo blood sample collection
Andere Namen:
Ancillary studies Given PO
Andere Namen:
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) |
|
Experimental: Non-adherers arm I (IP)
See Detailed Description. |
Undergo blood sample collection
Andere Namen:
Ancillary studies Given PO
Andere Namen:
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 |
|
Experimental: Non-adherers arm II (U-iIP)
See Detailed Description. |
Undergo blood sample collection
Andere Namen:
Ancillary studies Given PO
Andere Namen:
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
6-mercaptopurine (6MP) adherence (baseline non-adherers)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Smita Bhatia, Children's Oncology Group
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphatische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Leukämie, lymphatisch
- Leukämie
- Hämische und lymphatische Krankheiten
- Vorläuferzelle lymphoblastische Leukämie-Lymphom
- Schwefelverbindungen
- Organische Chemikalien
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Untersuchungstechniken
- Klinische Labortechniken
- Diagnosetechniken und Verfahren
- Diagnose
- Purines
- Gesundheitsdienste
- Belegschaft und Dienstleistungen für Gesundheitseinrichtungen
- Präventive Gesundheitsdienste
- Sozioökonomische Faktoren
- Bevölkerungseigenschaften
- Sulfhydrylverbindungen
- Gesundheitserziehung
- Mercaptopurin
- Bildungsstatus
- Handhabung von Proben
- Azathiopurin
- Gesundheitsförderung
Andere Studien-ID-Nummern
- ACCL2433
- UG1CA189955 (US NIH Stipendium/Vertrag)
- ACCL2433 (Andere Kennung: CTEP)
- NCI-2024-08458 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- COG-ACCL2433 (Andere Kennung: DCP)
- ACCL2433 (Andere Kennung: Children's Oncology Group)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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