Clinical trial · Interventional
An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADHERE | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Phase 1 - Intervention
- description
- 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.
- interventionNames
- Behavioral: ADHERE
- type
- NO_INTERVENTION
- label
- Phase 2 - Control Group
- description
- 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.
- type
- EXPERIMENTAL
- label
- Phase 2 - Intervention Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available