Anatomic Stage I Breast Cancer AJCC v8NCT04086875
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
A study testing Focus Group, Text Message and Best Practice in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by Thomas Jefferson University at 7 sites in United States.
Trial summary
This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Focus Group, Text Message and Best Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Nov 2018to 24 Sep 2024
- 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
- Woman diagnosed with stage I-III breast cancer (BCa).
- Hormone receptor positive tumor.
- Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
- Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
- At least 12 months of AHT recommended.
- Able to read and understand English.
Show all 9Show fewer
- Able to provide informed consent.
- Have a mobile device with text (TXT) capability.
- Know or willing to learn how to use TXT.
Who cannot join
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Jefferson Health - Abington
Abington, Pennsylvania, 19001
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Jefferson Health - Northeast (Aria Torresdale)
Philadelphia, Pennsylvania, 19114
Thomas Jefferson University - Methodist Hospital
Philadelphia, Pennsylvania, 19148
Jefferson Health - South Jersey
Sewell, New Jersey, 08080
About this study
Official title: A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVES:
- Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVES:
- Explore whether age (=< 45 versus [vs.] > 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress.
OUTLINE:
PHASE I: Participants attend focus groups on adherence to hormone therapy.
PHASE II: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.
GROUP II: Participants receive usual care.
After completion of study, participants are followed up at 3, 6, and 12 months.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Being tested
- Focus Group, Text Message, Best Practice, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Participate in focus group
Text MessageOther
Also called SMS Text, SMS Text Message, Text
Receive text messages
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (focus groups) | Experimental | Participants attend focus groups on adherence to hormone therapy. Receives: Behavioral: Focus Group; Other: Questionnaire Administration |
| Phase II Group 1 (text messages) | Experimental | Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence. Receives: Other: Text Message; Other: Questionnaire Administration |
| Phase II Group II (usual care) | Active comparator | Participants receive usual care. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjuvant hormone therapy (AHT) adherence
Assessed by wireless smart pill bottles for all participants. Daily adherence will be defined as accessing the pill bottle once per 24 hour period. Proportion adherence will be summarized by week and study arm, and presented graphically.
Measured: Up to 12 months
Symptom distress
Measured by the Breast Cancer Prevention Trial Symptom Scale, which has sound psychometric properties in breast cancer (BCa) patients. There are a total of 43 items in the scale across eight domains. Each item is a five-point Likert scale, ranging from 0 (not at all) to 4 (extremely), used to rate symptoms. Items accounting for side effects specifically related to AHT (e.g., bone pain) and other general symptoms (e.g., constipation) are added. Participants are asked whether they are bothered by each symptom and whether they think it related to their AHT or not. The two resulting scales consist of the sum of the endorsed symptom total each woman does or does not attribute to AHT.
Measured: Up to 12 months
Secondary outcomes (2)
Cognitive-affective barriers for AHT adherence
Will be developed and will test the mediating effect of cognitive affective barriers on proportion of days adherent (average over 12 months)
Measured: Up to 12 months
Cognitive-affective barriers for symptom distress
Will be developed and will test the mediating effect of cognitive affective barriers on the difference between baseline and 12-month symptom distress. Symptom distress is measured by the Breast Cancer Prevention Trial Symptom Scale
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start7 Nov 2018
- Primary completion24 Sep 2024 (estimated)
- Study completion24 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- 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
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kuang-Yi Wen, Thomas Jefferson University
- Investigators
- Kuang-Yi Wen, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086875
- Sponsor's protocol ID
- 19F.265
- Other IDs
- R01CA222246
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2019
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
- ClinicalTrials.gov ID
- NCT04086875
- Acronym / sponsor ID
- 19F.265
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 24 Sep 2024 (estimated)
- First posted
- 12 Sep 2019 (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.
This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.
Detailed description
PRIMARY OBJECTIVES:
- Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVES:
- Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVES:
- Explore whether age (=< 45 versus [vs.] > 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress.
OUTLINE:
PHASE I: Participants attend focus groups on adherence to hormone therapy.
PHASE II: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.
GROUP II: Participants receive usual care.
After completion of study, participants are followed up at 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (focus groups) | Experimental | Behavioral: Focus Group, Other: Questionnaire AdministrationParticipants attend focus groups on adherence to hormone therapy. |
| Phase II Group 1 (text messages) | Experimental | Other: Text Message, Other: Questionnaire AdministrationParticipants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence. |
| Phase II Group II (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationParticipants receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Woman diagnosed with stage I-III breast cancer (BCa).
- Hormone receptor positive tumor.
- Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
- Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
- At least 12 months of AHT recommended.
Key exclusion criteria (1 listed)
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
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 |
|---|---|---|
| Focus GroupParticipate in focus group | Behavioural | Phase 1 (focus groups) |
| Text MessageAlso: SMS Text, SMS Text Message, TextReceive text messages | Other | Phase II Group 1 (text messages) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Phase II Group II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Phase 1 (focus groups), Phase II Group 1 (text messages), Phase II Group II (usual care) |
Primary outcome
Adjuvant hormone therapy (AHT) adherence
Time frame: Up to 12 months
Assessed by wireless smart pill bottles for all participants. Daily adherence will be defined as accessing the pill bottle once per 24 hour period. Proportion adherence will be summarized by week and study arm, and presented graphically.
Symptom distress
Time frame: Up to 12 months
Measured by the Breast Cancer Prevention Trial Symptom Scale, which has sound psychometric properties in breast cancer (BCa) patients. There are a total of 43 items in the scale across eight domains. Each item is a five-point Likert scale, ranging from 0 (not at all) to 4 (extremely), used to rate symptoms. Items accounting for side effects specifically related to AHT (e.g., bone pain) and other general symptoms (e.g., constipation) are added. Participants are asked whether they are bothered by each symptom and whether they think it related to their AHT or not. The two resulting scales consist of the sum of the endorsed symptom total each woman does or does not attribute to AHT.
2 secondary outcomes
Cognitive-affective barriers for AHT adherence
Time frame: Up to 12 months
Cognitive-affective barriers for symptom distress
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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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.
Kuang-Yi Wen, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group, Text Message and Best Practice in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by Thomas Jefferson University at 7 sites 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 1 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
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?
Adjuvant hormone therapy (AHT) adherence (time frame: Up to 12 months). The study lists 2 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 10 Jun 2024.