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

NCT04719455 | Unknown

• 1 other identifier: NL74126.091.20
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• (preliminary) intervention effects on adherence

  1 year

• (preliminary) intervention effects on physical activity

  change from baseline at 6 and 12 months

• (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 self-management

  change from baseline at 12 months

Study Arms (4)

Intervention treatment experienced patients

EXPERIMENTAL

AIMS

Behavioral: Adherence Improving self-Management Strategy

Intervention starting patients

EXPERIMENTAL

AIMS

Behavioral: Adherence Improving self-Management Strategy

Control group treatment experienced patients

OTHER

Regular care

Other: Regular care

Control group starting patients

OTHER

Regular care

Other: Regular care

Interventions

Adherence Improving self-Management Strategy BEHAVIORAL

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.

Intervention starting patients; Intervention treatment experienced patients

Regular care OTHER

Treatment as usual (appointments with nurse/nurse practioner with regular content)

Control group starting patients; Control group treatment experienced patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Bernhoven

Uden, 5406 PT, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anna M Janssen, Msc

CONTACT

0031243697967; Anna.Janssen@radboudumc.nl

Joelle Dam, Msc

CONTACT

Joelle.Dam@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 22, 2021
• Study Start: December 13, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 22, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)