Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET)
NCT ID: NCT04719455
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
64 participants
INTERVENTIONAL
2020-12-13
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Breast cancer is the most prevalent cancer in Dutch women. Adjuvant endocrine therapy (AET) substantially improves chances for survival after primary breast cancer. In practice, many women experience difficulties to adhere to treatment: besides missing single or multiple doses of medication, up to 50% of patients stop treatment prematurely due to decreased treatment motivation over time and burden of side effects. Together with patients and health care professionals, we adapted a cost-effective behavior change intervention (AIMS) for women using adjuvant endocrine therapy after breast cancer to an add-on module in regular follow up care.
Objective of the study:
The primary aim of this study is to pilot test the feasibility of the AIMS-AET intervention versus usual treatment on medication adherence in breast cancer survivors on adjuvant endocrine therapy. Intervention effects on psychosocial determinants and user experiences will be evaluated. The feasibility of testing the AIMS-AET intervention in a bigger RCT will be assessed. The secondary objective is to assess (preliminary) intervention effects on adherence, physical activity and on quality of life.
Study design:
A pilot randomised controlled trial comparing AIMS AET to usual care with an extensive mixed-methods process evaluation.
Study population:
Female outpatients of 2 Dutch hospitals with a prescription for adjuvant endocrine therapy after primary breast cancer. Intervention (if applicable):
An in-person delivered intervention imbedded in regular follow-up care during 9-months. Patients will receive an electronic monitoring System to track medication intake and a pedometer to count daily amount of steps. During the baseline visit, the health care professional (HCP) will use pre-tested materials for informing and motivating patients; and collaboratively set goals and plans for medication adherence and physical activity. During regular follow-up consultations with the HCP, personalized visual reports of medication intake and amount of steps will be evaluated to enhance patients awareness of their (non-)adherence and (in)activity and identify any problems and solutions to reduce undesired behaviour. The control group will receive usual treatment only.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
eHealth Intervention for Medication Adherence in Breast Cancer Survivors
NCT05324020
Motivational Enhancement Therapy to Improve Adherence to Aromatase Inhibitors
NCT02883361
Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment Adherence
NCT01081509
Factors Influencing Adherence to Adjuvant Endocrine Therapy
NCT06192446
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy
NCT04379570
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention treatment experienced patients
AIMS
Adherence Improving self-Management Strategy
An in-person delivered intervention imbedded in regular follow-up care during 9-months. Patients will receive an electronic monitoring System to track medication intake and a pedometer to count daily amount of steps. During the baseline visit, the health care professional (HCP) will use pre-tested materials for informing and motivating patients; and collaboratively set goals and plans for medication adherence and physical activity. During regular follow-up consultations with the HCP, personalized visual reports of medication intake and amount of steps will be evaluated to enhance patients awareness of their (non-)adherence and (in)activity and identify any problems and solutions to reduce undesired behaviour. The control group will receive usual treatment only.
Intervention starting patients
AIMS
Adherence Improving self-Management Strategy
An in-person delivered intervention imbedded in regular follow-up care during 9-months. Patients will receive an electronic monitoring System to track medication intake and a pedometer to count daily amount of steps. During the baseline visit, the health care professional (HCP) will use pre-tested materials for informing and motivating patients; and collaboratively set goals and plans for medication adherence and physical activity. During regular follow-up consultations with the HCP, personalized visual reports of medication intake and amount of steps will be evaluated to enhance patients awareness of their (non-)adherence and (in)activity and identify any problems and solutions to reduce undesired behaviour. The control group will receive usual treatment only.
Control group treatment experienced patients
Regular care
Regular care
Treatment as usual (appointments with nurse/nurse practioner with regular content)
Control group starting patients
Regular care
Regular care
Treatment as usual (appointments with nurse/nurse practioner with regular content)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adherence Improving self-Management Strategy
An in-person delivered intervention imbedded in regular follow-up care during 9-months. Patients will receive an electronic monitoring System to track medication intake and a pedometer to count daily amount of steps. During the baseline visit, the health care professional (HCP) will use pre-tested materials for informing and motivating patients; and collaboratively set goals and plans for medication adherence and physical activity. During regular follow-up consultations with the HCP, personalized visual reports of medication intake and amount of steps will be evaluated to enhance patients awareness of their (non-)adherence and (in)activity and identify any problems and solutions to reduce undesired behaviour. The control group will receive usual treatment only.
Regular care
Treatment as usual (appointments with nurse/nurse practioner with regular content)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* estrogen receptor positive
* diagnosis of primary breast cancer and active prescription of tamoxifen or aromatase inhibitors
* Not being treated with adjuvant endocrine therapy earlier (except voor neo-adjuvant endocrine therapy)
* started with adjuvant endocrine therapy in the last 4 weeks OR already taking adjuvant endocrine therapy (\>=3 months; remaining treatment duration minimal 2 years)
* age minimal 18 years
* Able to come to the outpatient ward of the hospital for appointments with the nurse or nurse practitioner
* Able to understand Dutch or having the possibility to bring someone who translates
Exclusion Criteria
* Currently being treated with neo adjuvant endocrine therapy
* distant metastases proven by a positron emission tomograph (PET) scan with fluordeoxyglucose (FDG) scan
* Other invasive malignancy, except for a malignancy being treated without chemotherapy more than 5 years ago and without evidence for recurrence. Patients with basal cell or plaveisel cell skin cancer are eligible for the study.
* Participation in another interventional study for adherence or physical activity
* Treatment with ovarian suppression
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bernhoven
Uden, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Joris van Extel
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL74126.091.20
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.