An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE

NCT02337296 | Completed

• 1 other identifier: RC103421
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

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

Cancer

Keywords

Motivational Interviewing; Cognitive Behavioral Therapy; Cancer; Oral Agents; Adherence

Outcome Measures

Primary Outcomes (1)

• Proof-of-concept of the ADHERE intervention among patients who are on oral agents.

  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.

  Calculated at the end of study (at 8-weeks)

Secondary Outcomes (1)

• 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)

  Calculated at the end of study (at 8-weeks)

Study Arms (3)

Phase 1 - Intervention

OTHER

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.

Behavioral: ADHERE

Phase 2 - Control Group

NO INTERVENTION

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.

Phase 2 - Intervention Group

EXPERIMENTAL

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.

Behavioral: ADHERE

Interventions

ADHERE BEHAVIORAL

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.

Phase 1 - Intervention; Phase 2 - Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to accept phone calls

Sponsors & Collaborators

• Michigan State University: lead
• Huron Medical Center: collaborator
• Allegiance Health: collaborator
• Sparrow Health System: collaborator

Study Sites (2)

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sandra L Spoelstra, PhD, RN

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: January 13, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (2)