Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET)

Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET): a Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Breast Neoplasms
• Intervention / Treatment: Behavioral: Adherence Improving self-Management Strategy; Other: Regular care

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Uden, Netherlands, 5406 PT
    • Recruiting
    • Bernhoven
    • Contact: Joris van Extel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention treatment experienced patients; AIMS	Behavioral: 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.
Experimental: Intervention starting patients; AIMS	Behavioral: 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.
Other: Control group treatment experienced patients; Regular care	Other: Regular care; Treatment as usual (appointments with nurse/nurse practioner with regular content)
Other: Control group starting patients; Regular care	Other: Regular care; Treatment as usual (appointments with nurse/nurse practioner with regular content)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention effects on psychosocial determinants (beliefs, motivation, social norm)	degree of agreement with statements about beliefs and motivation towards treatment and social norm assessed with a self-developed questionnaire	change from baseline at 12 months
Intervention effects on self-efficacy	degree of agreement with statements about self-efficacy regarding treatment measured with the Self Efficacy of Appropriate Medication use Scale (SEAMS) and additional self-developed items. Higher scores indicated higher levels of self-efficacy for medication adherence.	change from baseline at 12 months
Delivery of the intervention in everyday context	Quantitative assessement of intervention steps and content measured with a self-developed checklist for health care professionals	through study completion, an average of 1 year
Satisfaction of HCPs with the intervention	Qualitative assessment (semi-structured interviews) measuring to which extend HCPs perceive the intervention as acceptable practical and sustainable	through study completion, an average of 1 year
Satisfaction of patients with the intervention	Qualitative assessment (semi-structured interviews) measuring patient experiences with the intervention regarding acceptability and feasibility	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(preliminary) intervention effects on adherence	days of missed medication	1 year
(preliminary) intervention effects on physical activity	assessing habitual activity with the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH). Higher scores indicate more time spended on habitual physical activity.	change from baseline at 6 and 12 months
(preliminary) intervention effects on quality of life	assessed with the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES). Higher values reflect a better quality of life.	change from baseline at 12 months
(preliminary) intervention effects on social support	assessed with the Sociale Steun Lijst - Discrepanties (SSL-D). A higher score indicates a higher lack of social support.	change from baseline at 12 months
(preliminary) intervention effects on self-management	assessed with the Patient Activiation Measurement (PAM-13). A higher score indicates a higher level of self-management.	change from baseline at 12 months
Treatment as usual	Treatment as usual will be assessed by the Treatment as usual questionnaire (an open ended questionnaire) in HCPs	through study completion, an average of 1 year
Satisfaction of patients with usual care	qualitative semi-structured interviews with participants of the control group about their experiences of delivered care	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NL74126.091.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No