En skräddarsydd intervention för att främja följsamhet till läkemedel för tonåringar och unga vuxna med cancer
En skräddarsydd intervention för att främja medicinföljsamhet hos tonåringar och unga vuxna med cancer
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Meghan E. McGrady, PhD
- Telefonnummer: 513-803-8044
- E-post: Meghan.McGrady@cchmc.org
Studieorter
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- Har inte rekryterat ännu
- The University of Kansas Medical Center
-
Kontakt:
- Carolyn Bates, PhD
- E-post: cbates4@kumc.edu
-
-
New York
-
New York, New York, Förenta staterna, 1003230702
- Har inte rekryterat ännu
- Columbia University Irving Medical Center
-
Kontakt:
- Melissa Beauchemin, PhD
- E-post: mmp2123@cumc.columbia.edu
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45229
- Rekrytering
- Cincinnati Children's Hospital Medical Center
-
Kontakt:
- Meghan E McGrady, PhD
- Telefonnummer: 513-803-8044
- E-post: Meghan.McGrady@cchmc.org
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98105
- Rekrytering
- Seattle Children's Hospital
-
Kontakt:
- Tyler Ketterl, MD
- E-post: Tyler.Ketterl@seattlechildrens.org
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Övrig: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Medication Adherence
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Life (Mental Health)
Tidsram: 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)
Tidsram: 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
Tidsram: 6 months post-treatment
|
Number of oncology visits, lab draws, ED visits, and hospitalizations |
6 months post-treatment
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Meghan E. McGrady, PhD, Children's Hospital Medical Center, Cincinnati
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R37CA302422 (U.S.S. NIH-anslag/kontrakt)
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