- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02337296
An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE
This study includes a novel intervention entitled "ADHERE," which includes one semi-structured 30-minute face-to-face session and three 10-minute weekly phone sessions over 4 weeks, administered by an advanced practice nurse (APRN) to promote management of symptoms and adherence in patients prescribed oral anti-cancer agents. Innovations in cancer treatment are changing the treatment delivery landscape. It is projected that by 2015, 25% of treatment will be delivered in pill form. This shift in the treatment paradigm places greater responsibility on patients. However, patients with cancer are known to miss as much as one-third of the prescribed doses of oral agents required for treatment of their disease. Barriers to oral agent adherence include symptom severity, low self-efficacy, depressive symptoms, lack of motivation, or beliefs that the medicine will not help, age, and regimen complexity. The therapeutic outcome for those taking oral agents depends heavily on the ability of patients to adhere to the prescribed regimen. Thus, a critical need exists to test interventions that promote adherence and symptom management in patients taking oral agents.
ADHERE provides systematic patient education (PE) with the investigators evidence-based Medication Management and Symptom Management Toolkit (Toolkit). This is combined with brief cognitive behavioral therapy (CBT) to focus thoughts and beliefs to influence action; and motivational interviewing (MI) to elicit reasons from patients to take action. The National Cancer Institute (NCI), American Society of Clinical Oncology (ASCO), and Oncology Nursing Society (ONS) have made adherence to oral agents a priority. Thus, the investigators are testing ADHERE's impact on symptom severity and adherence to the oral agent regimen and determining the acceptability and feasibility of the intervention among patients with cancer.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Michigan
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Jackson, Michigan, Yhdysvallat, 49201
- Allegiance Health
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Port Huron, Michigan, Yhdysvallat, 48060
- Huron Medical Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Diagnosed with cancer
- Newly prescribed (within 60-days) an oral anti-cancer agent
- Have a phone and be willing and able to receive phone calls
- Able to read, speak, and understand English
- Cognitively intact and able to self-manage and follow direction, as evaluated by the Recruiter
Exclusion Criteria:
- Unable to accept phone calls
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Muut: Phase 1 - Intervention
Five patients will be enrolled consecutively for the ADHERE intervention and be followed in order to refine the intervention as needed.
This permits the investigation of the process of change at baseline, after the intervention, and across the phases.
|
ADHERE entails a face-to-face 30 minute session during week 1 while in the clinic/office and three subsequent ADHERE phone calls for 10 minutes each, weekly during weeks 2-4 to promote symptom management and adherence to their oral agent regimen. The face-to-face intervention and phone interactions will consist of Motivational Interviewing and Cognitive Behavioral Therapy interaction strategies. Each patient will be given a Medication Management and Symptoms Management Toolkit, to assist with symptom management at home. All patients (intervention and control) receive weekly assessments of symptom severity and oral agent adherence (weeks 2-7). At exit (week 8), all patients receive an assessment of depressive symptoms, self-efficacy, beliefs, motivation, symptom severity, and adherence. |
Ei väliintuloa: Phase 2 - Control Group
Following completion of Phase 1 and prior to initiation of enrollment in the intervention group, patients will be enrolled in the control group and will receive usual care.
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Kokeellinen: Phase 2 - Intervention Group
Following enrollment of all control group patients, the intervention group will be recruited and enrolled and the ADHERE intervention will be conducted by the trained APRN interventionist at cancer center.
|
ADHERE entails a face-to-face 30 minute session during week 1 while in the clinic/office and three subsequent ADHERE phone calls for 10 minutes each, weekly during weeks 2-4 to promote symptom management and adherence to their oral agent regimen. The face-to-face intervention and phone interactions will consist of Motivational Interviewing and Cognitive Behavioral Therapy interaction strategies. Each patient will be given a Medication Management and Symptoms Management Toolkit, to assist with symptom management at home. All patients (intervention and control) receive weekly assessments of symptom severity and oral agent adherence (weeks 2-7). At exit (week 8), all patients receive an assessment of depressive symptoms, self-efficacy, beliefs, motivation, symptom severity, and adherence. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Proof-of-concept of the ADHERE intervention among patients who are on oral agents.
Aikaikkuna: Calculated at the end of study (at 8-weeks)
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Indices used to evaluate proof-of-concept include proportion of those enrolled among all recruited, the proportion of those who complete the intervention among all enrolled into the intervention group, and proportion of those satisfied among those who complete the intervention.
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Calculated at the end of study (at 8-weeks)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Preliminary efficacy of the ADHERE intervention on adherence to oral agents. (proportion of pills taken compared to what was prescribed and will be considered continuous variables)
Aikaikkuna: Calculated at the end of study (at 8-weeks)
|
The primary efficacy outcome of the intervention will be oral agent adherence as measured weekly by proportion of pills taken compared to what was prescribed and will be considered continuous variables.
Total proportion of pills taken will also be calculated as a measure, i.e., the total number of pills taken divided by total number of pills prescribed.
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Calculated at the end of study (at 8-weeks)
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Sandra L Spoelstra, PhD, RN, Michigan State University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- RC103421
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