Clinical trial · Interventional
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors: A Randomized Clinical Pilot Trial
NCT02611544CI-TRIAL-00039222completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 one of the most prevalent, persistent, and disruptive sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated at up to 89%, with approximately half of cancer survivors reporting clinically significant levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our long-term goal is to develop, evaluate, and implement effective behavioral interventions for cancer survivors suffering with FCR.
Conditions
Conditions (17)
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 Neoplasms | 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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | — | UNRESOLVED |
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
| Survivorship Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Acceptance and Commitment Therapy
- description
- 6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.
- interventionNames
- Behavioral: Acceptance and Commitment Therapy
- type
- ACTIVE_COMPARATOR
- label
- Survivorship Education
- description
- 6 weeks, SE group will meet weekly for 2 hours at one of three facilities.
- interventionNames
- Behavioral: Survivorship Education
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Participants in this study will be eligible if they are: 1. ≥18 years old, 2. have been diagnosed with non-metastatic breast cancer (stages I-III), 3. have completed curative treatment for breast cancer, 4. have not experienced a cancer recurrence, and 5. report a clinically significant level of FCR (Fear of Cancer Recurrence Inventory-Short Form score of ≥ 13) Exclusion Criteria: Participants in this study will be ineligible if they are: 1. severe depression (PHQ-8 score of ≥ 20), 2. past participation in ACT or formal mindfulness training, and 3. limited English proficiency.
References
Publications (23)
- BACKGROUNDSimard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10. PMID 23475398
- BACKGROUNDKoch L, Jansen L, Brenner H, Arndt V. Fear of recurrence and disease progression in long-term (>/= 5 years) cancer survivors--a systematic review of quantitative studies. Psychooncology. 2013 Jan;22(1):1-11. doi: 10.1002/pon.3022. Epub 2012 Jan 10. PMID 22232030
- BACKGROUNDVickberg SM. The Concerns About Recurrence Scale (CARS): a systematic measure of women's fears about the possibility of breast cancer recurrence. Ann Behav Med. 2003 Winter;25(1):16-24. doi: 10.1207/S15324796ABM2501_03. PMID 12581932
- BACKGROUNDNeedham BL, Mezuk B, Bareis N, Lin J, Blackburn EH, Epel ES. Depression, anxiety and telomere length in young adults: evidence from the National Health and Nutrition Examination Survey. Mol Psychiatry. 2015 Apr;20(4):520-8. doi: 10.1038/mp.2014.89. Epub 2014 Sep 2. PMID 25178165
- BACKGROUNDDuggan C, Risques R, Alfano C, Prunkard D, Imayama I, Holte S, Baumgartner K, Baumgartner R, Bernstein L, Ballard-Barbash R, Rabinovitch P, McTiernan A. Change in peripheral blood leukocyte telomere length and mortality in breast cancer survivors. J Natl Cancer Inst. 2014 Apr;106(4):dju035. doi: 10.1093/jnci/dju035. Epub 2014 Mar 13. PMID 24627273
- BACKGROUNDLengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529. PMID 19235193
- Lebel S, Maheu C, Lefebvre M, Secord S, Courbasson C, Singh M, Jolicoeur L, Benea A, Harris C, Fung MF, Rosberger Z, Catton P. Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv. 2014 Sep;8(3):485-96. doi: 10.1007/s11764-014-0357-3. Epub 2014 Apr 23.