Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Intervention effects on psychosocial determinants (beliefs, motivation, social norm)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intervention effects on psychosocial determinants (beliefs, motivation, social norm)
时间窗: change from baseline at 12 months
degree of agreement with statements about beliefs and motivation towards treatment and social norm assessed with a self-developed questionnaire
Intervention effects on self-efficacy
时间窗: change from baseline at 12 months
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.
Delivery of the intervention in everyday context
时间窗: through study completion, an average of 1 year
Quantitative assessement of intervention steps and content measured with a self-developed checklist for health care professionals
Satisfaction of HCPs with the intervention
时间窗: through study completion, an average of 1 year
Qualitative assessment (semi-structured interviews) measuring to which extend HCPs perceive the intervention as acceptable practical and sustainable
Satisfaction of patients with the intervention
时间窗: through study completion, an average of 1 year
Qualitative assessment (semi-structured interviews) measuring patient experiences with the intervention regarding acceptability and feasibility
次要结局
- (preliminary) intervention effects on quality of life(change from baseline at 12 months)
- (preliminary) intervention effects on social support(change from baseline at 12 months)
- (preliminary) intervention effects on adherence(1 year)
- Satisfaction of patients with usual care(through study completion, an average of 1 year)
- (preliminary) intervention effects on physical activity(change from baseline at 6 and 12 months)
- (preliminary) intervention effects on self-management(change from baseline at 12 months)
- Treatment as usual(through study completion, an average of 1 year)