NCT04719455

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Neoplasms

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-12-13
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: Netherlands