En skræddersyet intervention til fremme af medicinoverholdelse for unge og unge voksne med kræft
En skræddersyet intervention til fremme af lægemiddeloverholdelse for unge og unge voksne med kræft
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Meghan E. McGrady, PhD
- Telefonnummer: 513-803-8044
- E-mail: Meghan.McGrady@cchmc.org
Studiesteder
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- Ikke rekrutterer endnu
- The University of Kansas Medical Center
-
Kontakt:
- Carolyn Bates, PhD
- E-mail: cbates4@kumc.edu
-
-
New York
-
New York, New York, Forenede Stater, 1003230702
- Ikke rekrutterer endnu
- Columbia University Irving Medical Center
-
Kontakt:
- Melissa Beauchemin, PhD
- E-mail: mmp2123@cumc.columbia.edu
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45229
- Rekruttering
- Cincinnati Children's Hospital Medical Center
-
Kontakt:
- Meghan E McGrady, PhD
- Telefonnummer: 513-803-8044
- E-mail: Meghan.McGrady@cchmc.org
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98105
- Rekruttering
- Seattle Children's Hospital
-
Kontakt:
- Tyler Ketterl, MD
- E-mail: Tyler.Ketterl@seattlechildrens.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Andet: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Medication Adherence
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life (Mental Health)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 6 months post-treatment
|
Number of oncology visits, lab draws, ED visits, and hospitalizations |
6 months post-treatment
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Meghan E. McGrady, PhD, Children's Hospital Medical Center, Cincinnati
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R37CA302422 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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