Clinical trial · Interventional
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors
Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fear | — | UNRESOLVED | — |
| Human Mammary Carcinoma | — | UNRESOLVED | — |
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
| Malignant Tumor of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
| Mammary Cancer | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance Commitment Therapy | Behavioral | — | UNRESOLVED |
| Cognitive Behavioral Therapy | Behavioral | — | UNRESOLVED |
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care (EUC)
- description
- The EUC group will meet for a single 90-minute coaching session via Zoom Health.
- interventionNames
- Behavioral: Enhanced Usual Care
- type
- ACTIVE_COMPARATOR
- label
- Acceptance Commitment Therapy (ACT)
- description
- The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.
- interventionNames
- Behavioral: Acceptance Commitment Therapy
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Behavioral Therapy (CBT)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (1)
- DERIVEDTorrisi 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. PMID 42400053