Clinical trial NCT04719455: Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET)
Official title: Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background of the study:

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.


Eligibility criteria: Inclusion Criteria:

* female gender
* 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:

* Not able to sign informed consent.
* 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

Primary outcomes:
measure: Intervention effects on psychosocial determinants (beliefs, motivation, social norm)
timeFrame: change from baseline at 12 months
measure: Intervention effects on self-efficacy
timeFrame: change from baseline at 12 months
measure: Delivery of the intervention in everyday context
timeFrame: through study completion, an average of 1 year
measure: Satisfaction of HCPs with the intervention
timeFrame: through study completion, an average of 1 year
measure: Satisfaction of patients with the intervention
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: (preliminary) intervention effects on adherence
timeFrame: 1 year
measure: (preliminary) intervention effects on physical activity
timeFrame: change from baseline at 6 and 12 months
measure: (preliminary) intervention effects on quality of life
timeFrame: change from baseline at 12 months
measure: (preliminary) intervention effects on social support
timeFrame: change from baseline at 12 months
measure: (preliminary) intervention effects on self-management
timeFrame: change from baseline at 12 months
measure: Treatment as usual
timeFrame: through study completion, an average of 1 year
measure: Satisfaction of patients with usual care
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Uden
country: Netherlands
facility: Bernhoven
Study officials:
References: