Breast NeoplasmNCT05364450
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors
A study testing Acceptance Commitment Therapy and Cognitive Behavioral Therapy in people with Breast Neoplasm and Breast Cancer, run by Indiana University at 1 site in United States.
Trial summary
Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Neoplasm, Breast Cancer, Breast Carcinoma
- What is being tested?
- Acceptance Commitment Therapy and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 9 Jul 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥18 years old.
- Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
- Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≤5 years prior (ongoing endocrine therapy is allowed).
- Patient has clinically significant FCR (FCR-7 score ≥17 at screening).
- Patient is willing to be randomized into any of the 3 arms of the trial and attend a 6-week videoconference group if randomly assigned to ACT or CBT and a single videoconference group if randomly assigned to EUC.
- Patient is able to speak and read English
Who cannot join
- Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
- Patient is currently participating in ACT, CBT, formal mindfulness meditation training, the "Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial," the "Thinking and Living With Cancer" study, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
- Patient has co-morbidities, medications, or deficits that would impair participation in any of the 3 groups (ACT, CBT or EUC), including: history of stroke, encephalitis, traumatic brain injury/surgery, Alzheimer's disease, or other dementia; severe depressive symptoms (PHQ-2 score ≥5 at screening); active substance abuse or uncontrolled bipolar disorder, psychosis, or schizophrenia; obvious hearing and/or communicative disability.
- Patient has opted out of pre-screening for research studies (sometimes noted in the electronic medical record)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, 46202
About this study
Official title: Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors
Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.
Read the detailed description
The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed.
Specific Aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Carcinoma, Malignant Neoplasm of Breast, Cancer of Breast, Mammary Neoplasms, Human
- Being tested
- Enhanced Usual Care, Acceptance Commitment Therapy, Cognitive Behavioral Therapy
- Keywords
- Fear of Cancer Recurrence, Fear of Cancer Return, Breast Cancer Survivor, Breast Cancer Remission
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareBehavioural
Also called EUC
Interventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship."
Acceptance Commitment TherapyBehavioural
Also called ACT
Interventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values.
Cognitive Behavioral TherapyBehavioural
Also called CBT
Interventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | The EUC group will meet for a single 90-minute coaching session via Zoom Health. Receives: Behavioral: Enhanced Usual Care |
| Acceptance Commitment Therapy (ACT) | Active comparator | The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks. Receives: Behavioral: Acceptance Commitment Therapy |
| Cognitive Behavioral Therapy (CBT) | Active comparator | The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fear of Cancer Recurrence from Baseline
The 43-item Fear of Cancer Recurrence Inventory (FCRI) includes triggers, psychological distress, coping strategies, reassurance seeking, insight, severity, and functional impairments subscales. Each item is rated on a scale from 0 (never, not at all, or I don't think about it) to 4 (all the time or a great deal), participants indicate the extent to which they are fearful, with higher scores indicating greater FCR.
Measured: given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Secondary outcomes (12)
Change in Fear of Cancer Recurrence Questionnaire - 7 (FCR-7) from Baseline
The 7-item FCR-7 assesses anxiety, worry, and strong feelings associated with cancer recurrence, coupled with items assessing cognitive and behavioral responses to FCR. The first six items are on a scale from 1 (not at all) to 5 (all the time). The seventh item assesses the extent to which worry about getting cancer again intrudes on thoughts and activities on a 0 (not at all) to 10 (great deal) scale. Higher scores indicate greater FCR.
Measured: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Concerns about Recurrence (CARS) from Baseline
The 4-item Concerns About Recurrence Scale includes frequency, potential for upset, consistency, and intensity of fears on a 1-4 scale. Higher scores indicate greater FCR.
Measured: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Fear of Cancer Recurrence Global Anchor
Participants will be asked "Overall, since starting your assigned study program, is your fear of cancer recurrence worse, about the same, or better?" Those rating their fear of cancer recurrence as "better" are then asked if their fear is "a little better," "somewhat better," "moderately better," "a lot better," or "completely better".
Measured: Given at 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Anxiety Symptoms from Baseline
The 7-item Generalized Anxiety Disorder Scale (GAD-7) assesses how often in the past two weeks participants have been bothered by symptoms of anxiety on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater anxiety.
Measured: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Anxiety from Baseline
The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety measure assesses how often participants felt various symptoms of anxiety in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater anxiety.
Measured: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Post-Traumatic Stress Symptoms from Baseline
The 22-item Impact of Events Scale-Revised (IES-R) assesses post-traumatic distress on a 0 (not at all) to 4 (extremely) scale, with higher scores indicating greater post traumatic distress.
Measured: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Depressive Symptoms from Baseline
The 8-item Patient Health Questionnaire (PHQ-8) depression scale assesses how often participants have been bothered with symptoms of depression over the past two weeks on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater depressive symptomatology.
Measured: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Depression from Baseline
The 4-item PROMIS Depression measure assesses how often participants felt various symptoms of depression in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater depression severity.
Measured: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Fatigue from Baseline
The 4-item PROMIS Fatigue measure assesses how often participants felt various symptoms of fatigue in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater fatigue severity.
Measured: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Sleep Disturbance from Baseline
The 4-item PROMIS Sleep Disturbance measure assesses how often participants experienced aspects of sleep disturbance in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater sleep disturbance.
Measured: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Coping from Baseline
The 28-item Brief COPE assesses how often participants have been utilizing a series of coping strategies since their cancer diagnosis on a 1 (I haven't been doing this at all) to 4 (I have been doing this a lot) scale, with higher scores indicating greater use of the coping strategy.
Measured: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Quality of Life from Baseline
The 10-item PROMIS Global Health measure assesses mental and physical health. The first nine items are on a 1 (poor or not at all) to 5 (excellent or completely) scale. The tenth item assesses average pain on a 0 (no pain) to 10 (worst pain imaginable) scale and is reverse scored. Higher scores are indicative of better global health.
Measured: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start17 Aug 2021
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health, Eskenazi Health, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shelley Johns, Indiana University
- Investigators
- Shelley A Johns, PsyD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364450
- Sponsor's protocol ID
- 11066
- Other IDs
- R01CA255480
- Status last verified
- Dec 2024
- First submitted
- 3 May 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIH funded study - public database
Publications
Danner A, Gowan T, Schwarz M, Hays M, Li Y, Johns SA. Breaking the Silence: A Mixed Methods Analysis Unveiling Barriers to Mental Health Service Use in Breast Cancer Survivors With Clinically Significant Distress. Psychooncology. 2026 Oct;35(10):e70599. doi: 10.1002/pon.70599.
PubMed 42947255Torrisi C, Hays ME, Li Y, Johns SA. Fear of Cancer Recurrence and Coping in Young Breast Cancer Survivors: A Secondary Analysis. Cancer Med. 2026 Jul;15(7):e72086. doi: 10.1002/cam4.72086.
PubMed 42400053
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05364450
- Acronym / sponsor ID
- 11066
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Carcinoma, Malignant Neoplasm of Breast, Cancer of Breast, Mammary Neoplasms, Human
- Keywords
- Fear of Cancer Recurrence, Fear of Cancer Return, Breast Cancer Survivor, Breast Cancer Remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health, Eskenazi Health, National Cancer Institute (NCI)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 6 May 2022 (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.
Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.
Detailed description
The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed.
Specific Aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareThe EUC group will meet for a single 90-minute coaching session via Zoom Health. |
| Acceptance Commitment Therapy (ACT) | Active comparator | Behavioral: Acceptance Commitment TherapyThe ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks. |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral TherapyThe CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is ≥18 years old.
- Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
- Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≤5 years prior (ongoing endocrine therapy is allowed).
- Patient has clinically significant FCR (FCR-7 score ≥17 at screening).
- Patient is willing to be randomized into any of the 3 arms of the trial and attend a 6-week videoconference group if randomly assigned to ACT or CBT and a single videoconference group if randomly assigned to EUC.
Key exclusion criteria (4 listed)
- Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
- Patient is currently participating in ACT, CBT, formal mindfulness meditation training, the "Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial," the "Thinking and Living With Cancer" study, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
- Patient has co-morbidities, medications, or deficits that would impair participation in any of the 3 groups (ACT, CBT or EUC), including: history of stroke, encephalitis, traumatic brain injury/surgery, Alzheimer's disease, or other dementia; severe depressive symptoms (PHQ-2 score ≥5 at screening); active substance abuse or uncontrolled bipolar disorder, psychosis, or schizophrenia; obvious hearing and/or communicative disability.
- Patient has opted out of pre-screening for research studies (sometimes noted in the electronic medical record)
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 |
|---|---|---|
| Enhanced Usual CareAlso: EUCInterventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship." | Behavioural | Enhanced Usual Care (EUC) |
| Acceptance Commitment TherapyAlso: ACTInterventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values. | Behavioural | Acceptance Commitment Therapy (ACT) |
| Cognitive Behavioral TherapyAlso: CBTInterventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance). | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
Change in Fear of Cancer Recurrence from Baseline
Time frame: given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
The 43-item Fear of Cancer Recurrence Inventory (FCRI) includes triggers, psychological distress, coping strategies, reassurance seeking, insight, severity, and functional impairments subscales. Each item is rated on a scale from 0 (never, not at all, or I don't think about it) to 4 (all the time or a great deal), participants indicate the extent to which they are fearful, with higher scores indicating greater FCR.
12 secondary outcomes
Change in Fear of Cancer Recurrence Questionnaire - 7 (FCR-7) from Baseline
Time frame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Concerns about Recurrence (CARS) from Baseline
Time frame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Fear of Cancer Recurrence Global Anchor
Time frame: Given at 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Anxiety Symptoms from Baseline
Time frame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Anxiety from Baseline
Time frame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Post-Traumatic Stress Symptoms from Baseline
Time frame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Depressive Symptoms from Baseline
Time frame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Depression from Baseline
Time frame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Fatigue from Baseline
Time frame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Sleep Disturbance from Baseline
Time frame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Coping from Baseline
Time frame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Quality of Life from Baseline
Time frame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
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 4 Dec 2024.
- Derived from this study: PubMed 42947255Danner A, Gowan T, Schwarz M, Hays M, Li Y, Johns SA. Breaking the Silence: A Mixed Methods Analysis Unveiling Barriers to Mental Health Service Use in Breast Cancer Survivors With Clinically Significant Distress. Psychooncology. 2026 Oct;35(10):e70599. doi: 10.1002/pon.70599.
- Derived from this study: PubMed 42400053Torrisi C, Hays ME, Li Y, Johns SA. Fear of Cancer Recurrence and Coping in Young Breast Cancer Survivors: A Secondary Analysis. Cancer Med. 2026 Jul;15(7):e72086. doi: 10.1002/cam4.72086.
- Individual participant dataSharing planned: Yes. NIH funded study - public database
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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.
Shelley A Johns, PsyD principal investigator
Indiana 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 Acceptance Commitment Therapy and Cognitive Behavioral Therapy in people with Breast Neoplasm and Breast Cancer, run by Indiana 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 6 inclusion and 4 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 4 Dec 2024. 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?
Change in Fear of Cancer Recurrence from Baseline (time frame: given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)). 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 NCT05364450, which also lists 2 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 4 Dec 2024.