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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719455
• Other study ID #: NL74126.091.20
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: Radboud University
• Contact: Anna M Janssen, Msc
• Phone: 0031243697967
• Email: Anna.Janssen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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:
• Regular care
Treatment as usual (appointments with nurse/nurse practioner with regular content)

Locations

Country	Name	City	State
Netherlands	Bernhoven	Uden

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	(preliminary) intervention effects on adherence	days of missed medication	1 year
Secondary	(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
Secondary	(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
Secondary	(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
Secondary	(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
Secondary	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
Secondary	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