CancerNCT02337296
An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE
A study testing ADHERE in people with Cancer, run by Michigan State University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ADHERE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to accept phone calls
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Allegiance Health
Jackson, Michigan, 49201
Huron Medical Center
Port Huron, Michigan, 48060
About this study
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.
Read the detailed description
Purpose/Aims: Over 50 oral agents in pill form are currently on the market, with projections that in three years, 25% of cancer treatment will be delivered in pill form with patients assuming responsibility for self-management at home. For oral agents to achieve a therapeutically effective level for cancer treatment, patients must strictly adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for treating the cancer. The aim of this study is to refine and determine the feasibility and preliminary efficacy of an intervention (entitled "ADHERE") that uses motivational interviewing (MI) to elicit reasons to adhere and brief cognitive behavioral therapy (CBT) as a mechanism for goal-oriented systematic patient education (PE) to promote adherence and symptom management among cancer patients prescribed oral agents. Significance: This study targets a challenging clinical problem among patients with a life-threatening disease, assisting them in adhering to and completing their cancer treatment, impacting symptoms, quality of life, and longevity. Framework: The Motivation and Behavior Skills Model guides this work. The model asserts even a well informed or highly motivated patient will have difficulty achieving and sustaining optimal adherence if they lack the skills required to acquire or self-manage or feel incapable of performing such behaviors. Main Variables: Adherence and symptom severity. Methods: This practice-based study will be conducted using a 4-week intervention (ADHERE) to promote adherence and symptom management in patients newly prescribed oral agents in two phases. Phase 1 will use a single-subject-design to consecutively enrolling 5-patients from a cancer center over 4-weeks and investigators will use an iterative process to refine ADHERE in a practice-based setting. Phase 2 will use an 8-week quasi-experimental sequential design, enrolling 60-patients (30 intervention \& 30 control) from 2-cancer centers to examine feasibility and preliminary efficacy of a 4-week ADHERE intervention and follow-up for 4-weeks to assess adherence and symptom management. Descriptive statistics will be provided as appropriate for all data collected, and 95% confidence intervals will be provided by using exact method for outcome variables, such as: the proportion of patients who are enrolled to participate in the study among those who are recruited; the proportion of ADHERE received by the patient over the four-week time period; and the proportion of patients who report high satisfaction with ADHERE. Exploratory analysis of efficacy as measured weekly by proportion of pills taken compared to what was prescribed. Implications: This study has the potential to have a transformative impact on oral agent adherence by developing an advanced practice registered nurse-led strategy to promote adherence among the increasing number of cancer patients who receive their cancer treatment in pill form. This intervention will lead to standardized care for patients newly prescribed oral agents. Results of this study will be used to inform the development of an R01 application to conduct a larger randomized trial to test the efficacy of this innovative intervention.
- Conditions
- Cancer
- Being tested
- ADHERE
- Keywords
- Motivational Interviewing, Cognitive Behavioral Therapy, Cancer, Oral Agents, Adherence
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHEREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ADHERE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Calculated at the end of study (at 8-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Huron Medical Center, Allegiance Health, Sparrow Health System
- Responsible party
- Principal investigator, Sandra Spoelstra, Michigan State University
- Investigators
- Sandra L Spoelstra, PhD, RN, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337296
- Sponsor's protocol ID
- RC103421
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE
- ClinicalTrials.gov ID
- NCT02337296
- Acronym / sponsor ID
- RC103421
- Conditions
- Cancer
- Keywords
- Motivational Interviewing, Cognitive Behavioral Therapy, Cancer, Oral Agents, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Huron Medical Center, Allegiance Health, Sparrow Health System
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose/Aims: Over 50 oral agents in pill form are currently on the market, with projections that in three years, 25% of cancer treatment will be delivered in pill form with patients assuming responsibility for self-management at home. For oral agents to achieve a therapeutically effective level for cancer treatment, patients must strictly adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for treating the cancer. The aim of this study is to refine and determine the feasibility and preliminary efficacy of an intervention (entitled "ADHERE") that uses motivational interviewing (MI) to elicit reasons to adhere and brief cognitive behavioral therapy (CBT) as a mechanism for goal-oriented systematic patient education (PE) to promote adherence and symptom management among cancer patients prescribed oral agents. Significance: This study targets a challenging clinical problem among patients with a life-threatening disease, assisting them in adhering to and completing their cancer treatment, impacting symptoms, quality of life, and longevity. Framework: The Motivation and Behavior Skills Model guides this work. The model asserts even a well informed or highly motivated patient will have difficulty achieving and sustaining optimal adherence if they lack the skills required to acquire or self-manage or feel incapable of performing such behaviors. Main Variables: Adherence and symptom severity. Methods: This practice-based study will be conducted using a 4-week intervention (ADHERE) to promote adherence and symptom management in patients newly prescribed oral agents in two phases. Phase 1 will use a single-subject-design to consecutively enrolling 5-patients from a cancer center over 4-weeks and investigators will use an iterative process to refine ADHERE in a practice-based setting. Phase 2 will use an 8-week quasi-experimental sequential design, enrolling 60-patients (30 intervention \& 30 control) from 2-cancer centers to examine feasibility and preliminary efficacy of a 4-week ADHERE intervention and follow-up for 4-weeks to assess adherence and symptom management. Descriptive statistics will be provided as appropriate for all data collected, and 95% confidence intervals will be provided by using exact method for outcome variables, such as: the proportion of patients who are enrolled to participate in the study among those who are recruited; the proportion of ADHERE received by the patient over the four-week time period; and the proportion of patients who report high satisfaction with ADHERE. Exploratory analysis of efficacy as measured weekly by proportion of pills taken compared to what was prescribed. Implications: This study has the potential to have a transformative impact on oral agent adherence by developing an advanced practice registered nurse-led strategy to promote adherence among the increasing number of cancer patients who receive their cancer treatment in pill form. This intervention will lead to standardized care for patients newly prescribed oral agents. Results of this study will be used to inform the development of an R01 application to conduct a larger randomized trial to test the efficacy of this innovative intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Intervention | Other | Behavioral: ADHEREFive 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. |
| 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 | Behavioral: ADHEREFollowing 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to accept phone calls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHEREADHERE 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. | Behavioural | Phase 1 - Intervention, Phase 2 - Intervention Group |
Primary outcome
Proof-of-concept of the ADHERE intervention among patients who are on oral agents.
Time frame: Calculated at the end of study (at 8-weeks)
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.
1 secondary outcome
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)
Time frame: Calculated at the end of study (at 8-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra L Spoelstra, PhD, RN principal investigator
Michigan State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHERE in people with Cancer, run by Michigan State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proof-of-concept of the ADHERE intervention among patients who are on oral agents. (time frame: Calculated at the end of study (at 8-weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.