Breast CancerSTRIDENCT03837496
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors
A study testing STRIDE in people with Breast Cancer and Adherence, Medication, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. Read more about this study
- Who is it for?
- Ages 21 months and older, women only
- Conditions the study is for
- Breast Cancer, Adherence, Medication
- What is being tested?
- STRIDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Age 21 or older
- Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer
- Within 1 week-36 months of starting adjuvant endocrine therapy
- Ability to read and respond in English
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Show all 9Show fewer
- Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 weeks)
- Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast cancer
- Indicates a score ≥4 on one of the three NCCN adapted distress thermometer study screening questions
Who cannot join
- Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
- Cognitive impairment that prohibits participation in the study
- Enrollment in a different clinical trial for breast cancer
- Current participation in formal group psychotherapy or other psychosocial intervention trial
- Undergoing primary treatment for other cancer (i.e., advanced stage cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial
The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.
Read the detailed description
Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET.
Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors.
Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.
Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 24 week study period. If the participants are randomized to receive the STRIDE intervention, the participant will have six weekly one-hour virtual (videoconferencing) sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study.
- Conditions
- Breast Cancer, Adherence, Medication
- Being tested
- STRIDE, Medication Monitoring Control
- Keywords
- Breast Cancer, Endocrine Therapy, Hormonal Therapy, Symptoms, Distress, Survivors
- Medical subject headings
- Breast Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDEOther
STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.
Medication Monitoring ControlOther
Care provided as standard by the hospital and medication monitoring
| Study group | Role | What they receive |
|---|---|---|
| STRIDE Run-In | Experimental | * Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment and 3-months post- enrollment Receives: Other: STRIDE |
| STRIDE | Experimental | * Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment Receives: Other: STRIDE |
| Medication Monitoring Control | Active comparator | * Medication monitoring plus standard care
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment Receives: Other: Medication Monitoring Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability
The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate > 50%), retention (follow-up assessment completion rate > 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]).
The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if >75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.
Measured: 12 weeks
Secondary outcomes (4)
Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period
Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.
Measured: Mean medication adherence rates over 24 weeks
Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline
Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as "I stop taking my adjuvant endocrine therapy medicine for a while." Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.
Measured: Baseline, and post-intervention at 12-weeks post-baseline
Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.
Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 ("Never" or "Very inconvenient") to 5 ("Always" or Very Convenient"). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.
Measured: Baseline, and post-intervention at 12-weeks post-baseline
Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline
Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.
Measured: Baseline and post-intervention at 12 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start28 Oct 2019
- Primary completion17 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jamie Jacobs, Massachusetts General Hospital
- Investigators
- Jamie M. Jacobs, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837496
- Sponsor's protocol ID
- 18-603
- Other IDs
- K07CA211107
- Acronym
- STRIDE
- Status last verified
- Nov 2022
- First submitted
- 8 Feb 2019
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Publications
Walsh LE, Dunderdale L, Horick N, Temel JS, Greer JA, Jacobs JM. Intervention-Related Changes in Coping Ability Drives Improvements in Mood and Quality of Life for Patients Taking Adjuvant Endocrine Therapy. Psychooncology. 2024 Dec;33(12):e70049. doi: 10.1002/pon.70049.
PubMed 39706803Walsh EA, Post K, Massad K, Horick N, Antoni MH, Penedo FJ, Safren SA, Partridge AH, Peppercorn J, Park ER, Temel JS, Greer JA, Jacobs JM. Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial. Breast Cancer Res Treat. 2024 Apr;204(3):547-559. doi: 10.1007/s10549-023-07228-z. Epub 2024 Jan 17.
PubMed 38231313Jacobs JM, Rapoport CS, Horenstein A, Clay M, Walsh EA, Peppercorn J, Temel JS, Greer JA. Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. BMJ Open. 2021 Jan 4;11(1):e041626. doi: 10.1136/bmjopen-2020-041626.
PubMed 33397667
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT03837496
- Acronym / sponsor ID
- STRIDE / 18-603
- Conditions
- Breast Cancer, Adherence, Medication
- Keywords
- Breast Cancer, Endocrine Therapy, Hormonal Therapy, Symptoms, Distress, Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 18 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.
Detailed description
Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET.
Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors.
Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.
Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 24 week study period. If the participants are randomized to receive the STRIDE intervention, the participant will have six weekly one-hour virtual (videoconferencing) sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STRIDE Run-In | Experimental | Other: STRIDE* Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician * Two 15-minute check-in phone calls later in the study * Participants will store hormonal therapy medication in a bottle provided by the study team. * Participants will complete questionnaires at enrollment and 3-months post- enrollment |
| STRIDE | Experimental | Other: STRIDE* Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window) * Two 15-minute check-in phone calls later in the study * Participants will store hormonal therapy medication in a bottle provided by the study team. * Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment |
| Medication Monitoring Control | Active comparator | Other: Medication Monitoring Control* Medication monitoring plus standard care * Participants will store hormonal therapy medication in a bottle provided by the study team. * Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment |
Who may qualify
- Ages
- 21 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age 21 or older
- Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer
- Within 1 week-36 months of starting adjuvant endocrine therapy
- Ability to read and respond in English
Key exclusion criteria (5 listed)
- Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
- Cognitive impairment that prohibits participation in the study
- Enrollment in a different clinical trial for breast cancer
- Current participation in formal group psychotherapy or other psychosocial intervention trial
- Undergoing primary treatment for other cancer (i.e., advanced stage cancer)
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 |
|---|---|---|
| STRIDESTRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques. | Other | STRIDE, STRIDE Run-In |
| Medication Monitoring ControlCare provided as standard by the hospital and medication monitoring | Other | Medication Monitoring Control |
Primary outcome
Feasibility and Acceptability
Time frame: 12 weeks
The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate > 50%), retention (follow-up assessment completion rate > 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]). The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if >75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.
4 secondary outcomes
Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period
Time frame: Mean medication adherence rates over 24 weeks
Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline
Time frame: Baseline, and post-intervention at 12-weeks post-baseline
Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.
Time frame: Baseline, and post-intervention at 12-weeks post-baseline
Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline
Time frame: Baseline and post-intervention at 12 weeks post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39706803Walsh LE, Dunderdale L, Horick N, Temel JS, Greer JA, Jacobs JM. Intervention-Related Changes in Coping Ability Drives Improvements in Mood and Quality of Life for Patients Taking Adjuvant Endocrine Therapy. Psychooncology. 2024 Dec;33(12):e70049. doi: 10.1002/pon.70049.
- Derived from this study: PubMed 38231313Walsh EA, Post K, Massad K, Horick N, Antoni MH, Penedo FJ, Safren SA, Partridge AH, Peppercorn J, Park ER, Temel JS, Greer JA, Jacobs JM. Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial. Breast Cancer Res Treat. 2024 Apr;204(3):547-559. doi: 10.1007/s10549-023-07228-z. Epub 2024 Jan 17.
- Derived from this study: PubMed 33397667Jacobs JM, Rapoport CS, Horenstein A, Clay M, Walsh EA, Peppercorn J, Temel JS, Greer JA. Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. BMJ Open. 2021 Jan 4;11(1):e041626. doi: 10.1136/bmjopen-2020-041626.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Jamie M. Jacobs, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIDE in people with Breast Cancer and Adherence, Medication, run by Massachusetts General Hospital 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 9 inclusion and 5 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 18 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility and Acceptability (time frame: 12 weeks). 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 NCT03837496, which also lists 3 linked publications.
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 18 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.