- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Michigan
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Jackson, Michigan, Forenede Stater, 49201
- Allegiance Health
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Port Huron, Michigan, Forenede Stater, 48060
- Huron Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: 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.
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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. |
Ingen indgriben: 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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Eksperimentel: 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.
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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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proof-of-concept of the ADHERE intervention among patients who are on oral agents.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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)
Tidsramme: Calculated at the end of study (at 8-weeks)
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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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sandra L Spoelstra, PhD, RN, Michigan State University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RC103421
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Kliniske forsøg med ADHERE
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Adherex Technologies, Inc.AfsluttetNeoplasmerForenede Stater
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Adherex Technologies, Inc.AfsluttetNeoplasmerForenede Stater, Canada
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Adherex Technologies, Inc.AfsluttetNeoplasmerItalien, Schweiz
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Adherex Technologies, Inc.US Oncology ResearchAfsluttetNeoplasmerForenede Stater
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Children's Hospital Medical Center, CincinnatiAfsluttet
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Bowdoin CollegeNational Institute of Mental Health (NIMH); MaineHealthAfsluttet
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The Cleveland ClinicIkke rekrutterer endnu
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Adherex Technologies, Inc.AfsluttetNeoplasmerForenede Stater
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Emory UniversityChildren's Healthcare of AtlantaAfsluttetMedfødt hjertesygdomForenede Stater
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Baylor College of MedicineThrasher Research FundAfsluttetHypotensionForenede Stater