Breast CancerNCT04719455
Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET)
A study testing Adherence Improving self-Management Strategy and Regular care in people with Breast Cancer and Breast Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Adherence Improving self-Management Strategy and Regular care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Joelle Dam, Msc contact
Netherlands1 site, 1 recruiting
- Recruiting
Bernhoven
Uden, 5406 PT
Joris van Extel
About this study
Official title: 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.
Read more
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
- Being tested
- Adherence Improving self-Management Strategy, Regular care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence Improving self-Management StrategyBehavioural
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.
Regular careOther
Treatment as usual (appointments with nurse/nurse practioner with regular content)
| Study group | Role | What they receive |
|---|---|---|
| Intervention treatment experienced patients | Experimental | AIMS Receives: Behavioral: Adherence Improving self-Management Strategy |
| Intervention starting patients | Experimental | AIMS Receives: Behavioral: Adherence Improving self-Management Strategy |
| Control group treatment experienced patients | Other | Regular care Receives: Other: Regular care |
| Control group starting patients | Other | Regular care Receives: Other: Regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
(preliminary) intervention effects on adherence
days of missed medication
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719455
- Sponsor's protocol ID
- NL74126.091.20
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04719455
- Acronym / sponsor ID
- NL74126.091.20
- Conditions
- Breast Cancer, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention treatment experienced patients | Experimental | Behavioral: Adherence Improving self-Management StrategyAIMS |
| Intervention starting patients | Experimental | Behavioral: Adherence Improving self-Management StrategyAIMS |
| Control group treatment experienced patients | Other | Other: Regular careRegular care |
| Control group starting patients | Other | Other: Regular careRegular care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence Improving self-Management StrategyAn 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. | Behavioural | Intervention starting patients, Intervention treatment experienced patients |
| Regular careTreatment as usual (appointments with nurse/nurse practioner with regular content) | Other | Control group starting patients, Control group treatment experienced patients |
Primary outcome
Intervention effects on psychosocial determinants (beliefs, motivation, social norm)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
Qualitative assessment (semi-structured interviews) measuring patient experiences with the intervention regarding acceptability and feasibility
7 secondary outcomes
(preliminary) intervention effects on adherence
Time frame: 1 year
(preliminary) intervention effects on physical activity
Time frame: change from baseline at 6 and 12 months
(preliminary) intervention effects on quality of life
Time frame: change from baseline at 12 months
(preliminary) intervention effects on social support
Time frame: change from baseline at 12 months
(preliminary) intervention effects on self-management
Time frame: change from baseline at 12 months
Treatment as usual
Time frame: through study completion, an average of 1 year
Satisfaction of patients with usual care
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joelle Dam, Msc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence Improving self-Management Strategy and Regular care in people with Breast Cancer and Breast Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna M Janssen, Msc (0031243697967, Anna.Janssen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention effects on psychosocial determinants (beliefs, motivation, social norm) (time frame: change from baseline at 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.