Un intervento personalizzato per promuovere l'aderenza terapeutica negli adolescenti e nei giovani adulti con cancro
Un intervento personalizzato per la promozione dell'aderenza terapeutica per adolescenti e giovani adulti con cancro
The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are:
- Does the tailored intervention increase adherence?
- Does the tailored intervention improve quality of life?
- Does the tailored intervention reduce health care utilization?
The researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence.
Participants will:
- Use an electronic pill bottle or box to store their medication
- Participate in intervention sessions
- Complete surveys before the intervention, after the intervention, and 6-months later
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. As part of this study, up to 160 adolescents and young adults (AYAs) with cancer will be randomized to one of these groups. Participants who enroll in this trial will be given an electronic pill bottle or box with a computer chip to store their medication. After using the electronic monitor for a few weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to one of the two groups and complete their assigned program. Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete questionnaires at post-treatment and again about 6 months later.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Meghan E. McGrady, PhD
- Numero di telefono: 513-803-8044
- Email: Meghan.McGrady@cchmc.org
Luoghi di studio
-
-
Kansas
-
Kansas City, Kansas, Stati Uniti, 66160
- Non ancora reclutamento
- The University of Kansas Medical Center
-
Contatto:
- Carolyn Bates, PhD
- Email: cbates4@kumc.edu
-
-
New York
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New York, New York, Stati Uniti, 1003230702
- Non ancora reclutamento
- Columbia University Irving Medical Center
-
Contatto:
- Melissa Beauchemin, PhD
- Email: mmp2123@cumc.columbia.edu
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45229
- Reclutamento
- Cincinnati Children's Hospital Medical Center
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Contatto:
- Meghan E McGrady, PhD
- Numero di telefono: 513-803-8044
- Email: Meghan.McGrady@cchmc.org
-
-
Washington
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Seattle, Washington, Stati Uniti, 98105
- Reclutamento
- Seattle Children's Hospital
-
Contatto:
- Tyler Ketterl, MD
- Email: Tyler.Ketterl@seattlechildrens.org
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient is 15.00 to 24.99 years of age
- Patient is diagnosed with cancer
- Patient is prescribed an oral anticancer/antitumor agent or prophylaxis
Exclusion Criteria:
- Patient is not fluent in English
- Patient evidences significant cognitive deficits
- Patient's medical status or treatment precludes participation
- Patient enrolled on a medical trial requiring medication storage in a trial-provided container
- Patient demonstrates greater than or equal to 95% adherence during run-in period
- Patient declines to use or has difficulty using electronic adherence monitoring device during run-in
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Tailored Program
8-week program including 4 coach visits and 4 text check-ins |
Participants will participate in 4 sessions with a coach, 1 every other week. During these sessions, the participant will work with their coach to identify a barrier to adherence they would like to target. Then, they will work with their coach to create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text reminder about the plan. |
|
Altro: Feedback Program (Uniform Standard of Care)
8-week feedback program including weekly texts |
Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Medication Adherence
Lasso di tempo: The 1-month period following the completion of one of the study programs.
|
Each participant will be given an electronic adherence monitoring device to store their medication. An electronic adherence monitoring device is a pill bottle or box with an embedded computer chip. The computer chip records each time the device is opened. These device openings, or actuations, will be compared with the patient's prescribed medication regimen to compute their adherence (defined as the percentage of doses taken as prescribed). |
The 1-month period following the completion of one of the study programs.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of Life (Mental Health)
Lasso di tempo: Approximately 1 month after completing one of the study programs
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Mental Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
Approximately 1 month after completing one of the study programs
|
|
Quality of Life (Physical Health)
Lasso di tempo: Approximately 1 month after completing one of the study programs
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Physical Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
Approximately 1 month after completing one of the study programs
|
|
Healthcare Utilization
Lasso di tempo: 6 months post-treatment
|
Number of oncology visits, lab draws, ED visits, and hospitalizations |
6 months post-treatment
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Meghan E. McGrady, PhD, Children's Hospital Medical Center, Cincinnati
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R37CA302422 (Sovvenzione/contratto NIH degli Stati Uniti)
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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