Breast CancerTHRIVENCT06388304
THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence
A study testing THRIVE Online PAT Program in people with Breast Cancer and DCIS, run by Joanna Arch at 1 site in United States.
Trial summary
The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, DCIS
- What is being tested?
- THRIVE Online PAT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 18 Apr 2025
- 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
- hormone receptor-positive breast cancer stages 0-3
- have finished primary treatment (chemotherapy/radiation/surgery)
- are prescribed endocrine therapy (ET) currently or within the last two years
- score above specified cut off (range, 0-10) on any of three questions:
- How upset are you by having to take anti-hormonal therapy
- How bothered are you by the side effects?
- How difficult is it for you to take your anti-hormonal medication every day?
- have internet access to complete online assessments and intervention components or agree to use and return a study wifi-activated iPad.
Who cannot join
- metastatic disease
- Individuals who are unable to interact with the intervention as needed. This includes those who are extremely visually impaired to the degree that they cannot see the screen and interact as required and individuals who cannot read and/or write in English. This is due to the nature of the intervention itself. If a participant is unable to interact with THRIVE as required, they are unlikely to benefit from the intervention or offer insightful feedback that can be used in refining the program.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence
The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer.
- Conditions
- Breast Cancer, DCIS
- Being tested
- THRIVE Online PAT Program
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE Online PAT ProgramBehavioural
Online program: behavioral intervention based on Positive Affect Training (PAT)
| Study group | Role | What they receive |
|---|---|---|
| Online Program | Experimental | Online program Receives: Behavioral: THRIVE Online PAT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of THRIVE intervention (AIM)
Acceptability of Implementation Measure (Weimer et al., 2017)
Measured: 1 week post-intervention
Feasibility of THRIVE intervention
Feasibility of Intervention Measure (Weimer et al., 2017)
Measured: 1 week post-intervention
Client Satisfaction Survey
Satisfaction and feedback on THRIVE intervention
Measured: 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start12 Mar 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanna Arch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joanna Arch, University of Colorado, Boulder
- Investigators
- Joanna Arch, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388304
- Sponsor's protocol ID
- 23-0556
- Acronym
- THRIVE
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.
PubMed 30998048Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.
PubMed 27699943Craske MG, Meuret AE, Echiverri-Cohen A, Rosenfield D, Ritz T. Positive affect treatment targets reward sensitivity: A randomized controlled trial. J Consult Clin Psychol. 2023 Jun;91(6):350-366. doi: 10.1037/ccp0000805. Epub 2023 Mar 9.
PubMed 36892884Arch JJ, Crespi CM, Levin ME, Genung SR, Nealis M, Mitchell JL, Bright EE, Albright K, Magidson JF, Stanton AL. Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors. Ann Behav Med. 2022 Aug 2;56(8):856-871. doi: 10.1093/abm/kaab118.
PubMed 35323853
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Positive Affect Training for Endocrine Therapy Medication Adherence
- ClinicalTrials.gov ID
- NCT06388304
- Acronym / sponsor ID
- THRIVE / 23-0556
- Conditions
- Breast Cancer, DCIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Joanna ArchUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 29 Apr 2024 (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.
The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Program | Experimental | Behavioral: THRIVE Online PAT ProgramOnline program |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- hormone receptor-positive breast cancer stages 0-3
- have finished primary treatment (chemotherapy/radiation/surgery)
- are prescribed endocrine therapy (ET) currently or within the last two years
- score above specified cut off (range, 0-10) on any of three questions:
- have internet access to complete online assessments and intervention components or agree to use and return a study wifi-activated iPad.
Key exclusion criteria (2 listed)
- metastatic disease
- Individuals who are unable to interact with the intervention as needed. This includes those who are extremely visually impaired to the degree that they cannot see the screen and interact as required and individuals who cannot read and/or write in English. This is due to the nature of the intervention itself. If a participant is unable to interact with THRIVE as required, they are unlikely to benefit from the intervention or offer insightful feedback that can be used in refining the program.
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 |
|---|---|---|
| THRIVE Online PAT ProgramOnline program: behavioral intervention based on Positive Affect Training (PAT) | Behavioural | Online Program |
Primary outcome
Acceptability of THRIVE intervention (AIM)
Time frame: 1 week post-intervention
Acceptability of Implementation Measure (Weimer et al., 2017)
Feasibility of THRIVE intervention
Time frame: 1 week post-intervention
Feasibility of Intervention Measure (Weimer et al., 2017)
Client Satisfaction Survey
Time frame: 1 week post-intervention
Satisfaction and feedback on THRIVE intervention
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 21 Jan 2026.
- Background: PubMed 30998048Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.
- Background: PubMed 27699943Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.
- Background: PubMed 36892884Craske MG, Meuret AE, Echiverri-Cohen A, Rosenfield D, Ritz T. Positive affect treatment targets reward sensitivity: A randomized controlled trial. J Consult Clin Psychol. 2023 Jun;91(6):350-366. doi: 10.1037/ccp0000805. Epub 2023 Mar 9.
- Background: PubMed 35323853Arch JJ, Crespi CM, Levin ME, Genung SR, Nealis M, Mitchell JL, Bright EE, Albright K, Magidson JF, Stanton AL. Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors. Ann Behav Med. 2022 Aug 2;56(8):856-871. doi: 10.1093/abm/kaab118.
- 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.
Joanna Arch, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE Online PAT Program in people with Breast Cancer and DCIS, run by Joanna Arch 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 8 inclusion and 2 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 21 Jan 2026. 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?
Acceptability of THRIVE intervention (AIM) (time frame: 1 week post-intervention). The study lists 3 primary outcomes in all. 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 NCT06388304, which also lists 4 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 21 Jan 2026.