Self-management Intervention (SM-AET)NCT02707471
Improving Well-Being for Breast Cancer Patients
A study testing SM-AET and general health education in people with Self-management Intervention (SM-AET) and General Health Education, run by Duke University at 1 site in United States.
Trial summary
Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Self-management Intervention (SM-AET), General Health Education
- What is being tested?
- SM-AET and general health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 9 Nov 2023
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Stage I to III breast cancer
- hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptor
- completed local definitive treatment (i.e., surgery, chemotherapy, radiation),
- within 12 months of beginning AET
- at least 18 months of AET recommended
Who cannot join
- <21 years of age,
- severe cognitive or hearing impairment that is documented in the medical record
- unable to provide meaningful consent (e.g., severe cognitive impairment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Improving Well-Being for Breast Cancer Patients Taking Adjuvant Endocrine Therapy
Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in our preliminary work, 65% of breast cancer patients taking AET reported one or more non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial, we will conduct user testing of the self-management intervention protocol with 20 women. In the proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be randomly assigned to one of two conditions: 1) a self-management intervention for improving adherence and symptom management, or 2) a general health education control condition. The self-management intervention integrates three key theory-based strategies for improving adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor symptoms), behavioral strategies for improving medication adherence, and symptom and medication education. The intervention addresses the specific symptoms a woman is experiencing and is designed to meet the needs of women who are at high risk for non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management intervention is administered by a nurse via the telephone, and combines the use of phone calls and tailored interactive voice messaging based on information exchanged during phone sessions and real-time adherence data obtained from smart medication bottles. Women randomly assigned to the control condition will receive a general health education intervention that is delivered by a nurse via the telephone. This study will take place in the Duke Cancer Institute breast clinic and in community hospitals that are members of the Duke Cancer Network, which will allow access to women receiving care outside the medical center setting and increase generalizability of findings to a variety of settings. Adherence to AET will be assessed over the 18 month period following study enrollment using wireless smart medication bottles that provide real-time adherence data and pill counts completed by study staff during in-person study assessments. Patient-reported outcome measures assessing symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation of the self-management intervention, the cost effectiveness of the intervention will be evaluated.
- Being tested
- SM-AET, general health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-AETBehavioural
self-management for improving adherence and reducing symptom interference (SM-AET)
general health educationBehavioural
general health education intervention that focuses on improving overall health.
| Study group | Role | What they receive |
|---|---|---|
| SM-AET | Experimental | a self-management intervention for enhancing skills to improve adherence and reduce symptom interference (SM-AET) (active intervention group) Receives: Behavioral: SM-AET |
| general health education Intervention | Other | general health education Intervention (control group) Receives: Behavioral: general health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent daily adherence assessed over 18 months
The SM-AET protocol includes eight sessions and two maintenance calls administered by a nurse via the phone. The intervention also includes interactive voice messaging that is tailored based on participants' medication taking behavior. Adherence to AET will be assessed using smart pill bottles (i.e., bottle opening and percent of pills remaining).
Measured: 18 month
Secondary outcomes (14)
Change in medication taking behaviors
A revised 16-item measure based on the Medication Adherence Rating Scale and our prior studies is used to assess self-reported adherence. Items were revised to refer specifically to participants' AET medication, assess medication-taking behaviors related to adherence (e.g., forgetting), and capture intentional and unintentional nonadherence over the past month.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Menopausal Symptoms and Symptom Interference
The 32-item Menopause Specific Quality of Life Questionnaire (MENQOL) assesses the degree of symptom interference in the past week related to four domains: physical symptoms, vasomotor symptoms, psychosocial symptoms, and sexual symptoms.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Pain and Joint Stiffness/Aching and Symptom Interference
The Brief Pain Inventory - Short form (BPI-SF) is used to assess pain interference in the past week across 9 areas (e.g., general activity, mood, sleep, enjoyment of life). Five items adapted from the Arthritis Impact Measurement Scale-II (AIMS-II; e.g., How would you describe the joint aching that you usually had?; How often did joint aching make it difficult to sleep?) and four items modified from the BPI-SF pain severity scale (e.g., Please rate stiffness in your joints by selecting the one number that best describes your stiffness at its worst in the past week) are used to measure aching and joint stiffness.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Sleep Problems
The 7-item Insomnia Severity Index (ISI) is a measure of participants' perceived severity of sleep difficulties and the interference of these difficulties with emotional distress, daily functioning, and quality of life in the last two weeks.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Fatigue
The 8-item Patient Reported Outcomes Information System Fatigue Scale (PROMIS Fatigue) assesses fatigue over the past seven days.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in psychological distress
The eight-item Patient Reported Outcomes Information System Depression Scale (PROMIS Depression) assesses depressive symptoms. The eight-item Patient Reported Outcomes Information System Anxiety Scale (PROMIS Anxiety) is used to assess symptoms of anxiety.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Physical Functioning and Symptom Interference: 6-minute walk test
The 6-minute walk test assesses women's abilities to exert effort in activity and the degree of pain experienced during activity. Women are asked to walk along an indoor hallway for 6-minutes with the goal being to walk as far as possible within the allotted time. Total distance in feet walked during the allotted time is recorded.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Physical Functioning and Symptom Interference: Get Up and Go test
In the timed get up and go test participants are asked to stand up from a chair, walk 10 feet, turn, walk back to the chair, and sit down. Total time to complete the task is recorded in seconds.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Physical Functioning and Symptom Interference: Grip strength
Grip strength is assessed using a latex free JAMAR hydraulic hand dynamometer. The participant sits with her forearm in a neutral position, and wrist between 0° and 30° dorsiflexion and between 0° and 15° ulnar deviation. She then squeezes the handle of the dynamometer as hard as she can. Data is recorded in pounds. Three trials are conducted with each hand.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in perceived barriers to taking AET medication
Eleven items assess barriers to taking medication over the past month. Specifically, women rate how often certain situations (e.g., forgetfulness, problematic side effects, being out of routine) make it difficult for them to take their medications every day.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in treatment interference
Five items from the Treatment Burden Questionnaire assess how often, time spent, frequency, or inconveniences associated with recommended health care present a problem for the participant.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in beliefs about medication
The 10-item Beliefs about Medicines Questionnaire (BMQ) assesses perceived necessity and concerns about AET (e.g., my health depends on my medicine, my medicine protects me from becoming ill).
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Change in self-efficacy for managing symptoms and taking AET
An 8-item scale will measure self-efficacy for managing symptoms. Participants are asked to rate how confident they are that they can manage common symptoms (e.g., aches and plain, sexual side effects and hot flashes/sweating) related to AET. The 13-item Self-Efficacy for Appropriate Medication Use Scale assesses self-efficacy for taking medications across various situations (e.g., when no one reminds you to take the medicine, when you have a busy day planned, when you are away from home).
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Estimate of cost-effectiveness of the CST-AET intervention
The 5-level EuroQol-5 Dimensions (EQ-5D-5L) health questionnaire assesses current health status across five domains that map to a 0 (dead) to 1 (perfect health) scale representing the relative utility (or desirability) of health-related quality of life. These utility weights are used to derive quality-adjusted life years (QALYs).
Measured: Baseline, 3 months, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start14 Mar 2017
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-management Intervention (SM-AET)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707471
- Sponsor's protocol ID
- Pro00068595
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2016
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shelby RA, Dorfman CS, Bosworth HB, Keefe F, Sutton L, Owen L, Corsino L, Erkanli A, Reed SD, Arthur SS, Somers T, Barrett N, Huettel S, Gonzalez JM, Kimmick G. Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemp Clin Trials. 2019 Jan;76:120-131. doi: 10.1016/j.cct.2018.11.010. Epub 2018 Nov 22.
PubMed 30472215
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Well-Being for Breast Cancer Patients Taking Adjuvant Endocrine Therapy
- ClinicalTrials.gov ID
- NCT02707471
- Acronym / sponsor ID
- Pro00068595
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 14 Mar 2016 (estimated)
- 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.
Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in our preliminary work, 65% of breast cancer patients taking AET reported one or more non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial, we will conduct user testing of the self-management intervention protocol with 20 women. In the proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be randomly assigned to one of two conditions: 1) a self-management intervention for improving adherence and symptom management, or 2) a general health education control condition. The self-management intervention integrates three key theory-based strategies for improving adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor symptoms), behavioral strategies for improving medication adherence, and symptom and medication education. The intervention addresses the specific symptoms a woman is experiencing and is designed to meet the needs of women who are at high risk for non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management intervention is administered by a nurse via the telephone, and combines the use of phone calls and tailored interactive voice messaging based on information exchanged during phone sessions and real-time adherence data obtained from smart medication bottles. Women randomly assigned to the control condition will receive a general health education intervention that is delivered by a nurse via the telephone. This study will take place in the Duke Cancer Institute breast clinic and in community hospitals that are members of the Duke Cancer Network, which will allow access to women receiving care outside the medical center setting and increase generalizability of findings to a variety of settings. Adherence to AET will be assessed over the 18 month period following study enrollment using wireless smart medication bottles that provide real-time adherence data and pill counts completed by study staff during in-person study assessments. Patient-reported outcome measures assessing symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation of the self-management intervention, the cost effectiveness of the intervention will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SM-AET | Experimental | Behavioral: SM-AETa self-management intervention for enhancing skills to improve adherence and reduce symptom interference (SM-AET) (active intervention group) |
| general health education Intervention | Other | Behavioral: general health educationgeneral health education Intervention (control group) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of Stage I to III breast cancer
- hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptor
- completed local definitive treatment (i.e., surgery, chemotherapy, radiation),
- within 12 months of beginning AET
- at least 18 months of AET recommended
Key exclusion criteria (3 listed)
- <21 years of age,
- severe cognitive or hearing impairment that is documented in the medical record
- unable to provide meaningful consent (e.g., severe cognitive impairment).
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 |
|---|---|---|
| SM-AETself-management for improving adherence and reducing symptom interference (SM-AET) | Behavioural | SM-AET |
| general health educationgeneral health education intervention that focuses on improving overall health. | Behavioural | general health education Intervention |
Primary outcome
Percent daily adherence assessed over 18 months
Time frame: 18 month
The SM-AET protocol includes eight sessions and two maintenance calls administered by a nurse via the phone. The intervention also includes interactive voice messaging that is tailored based on participants' medication taking behavior. Adherence to AET will be assessed using smart pill bottles (i.e., bottle opening and percent of pills remaining).
14 secondary outcomes
Change in medication taking behaviors
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Menopausal Symptoms and Symptom Interference
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Pain and Joint Stiffness/Aching and Symptom Interference
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Sleep Problems
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Fatigue
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in psychological distress
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Physical Functioning and Symptom Interference: 6-minute walk test
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Physical Functioning and Symptom Interference: Get Up and Go test
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in Physical Functioning and Symptom Interference: Grip strength
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in perceived barriers to taking AET medication
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in treatment interference
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in beliefs about medication
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Change in self-efficacy for managing symptoms and taking AET
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Estimate of cost-effectiveness of the CST-AET intervention
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 30472215Shelby RA, Dorfman CS, Bosworth HB, Keefe F, Sutton L, Owen L, Corsino L, Erkanli A, Reed SD, Arthur SS, Somers T, Barrett N, Huettel S, Gonzalez JM, Kimmick G. Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemp Clin Trials. 2019 Jan;76:120-131. doi: 10.1016/j.cct.2018.11.010. Epub 2018 Nov 22.
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.
Rebecca Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SM-AET and general health education in people with Self-management Intervention (SM-AET) and General Health Education, run by Duke University at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 13 Nov 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent daily adherence assessed over 18 months (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707471, which also lists 1 linked publication.
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 13 Nov 2023.