Clinical trial · Interventional
A Therapy Intervention to Address Fear of Recurrence in Men and Women With Cancer
Efficacy of a Cognitive-Existential Therapy Intervention to Address Fear of Recurrence in Men and Women With Cancer: A Randomized Clinical Trial
- 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 frequently cited unmet needs among survivors, and affects 22 to 87% of cancer patients. The objective of this study is to test the effectiveness of a six weekly, 1-hour manual-based individual therapy to reduce FCR among cancer survivors. A total of n=20 cancer survivors will be recruited from the Ottawa Hospital Cancer Centre (TOHCC) in Ottawa, Ontario. Participants will be randomly selected to receive either the psychotherapy intervention or standard care at TOHCC. All participants will be asked to complete a series of questionnaire packages at 3 time points. Ultimately, decreasing FCR can improve quality of life and reduce distress.The objective of this RCT study is to test the effectiveness of a six weekly, 1 hour manual-based cognitive-existential (CE) individual intervention to reduce FCR among cancer survivors. It is hypothesized that: 1. Participants in the intervention group will have lower scores on the primary outcome measure of FCR after treatment, as compared to a standard care control group 2. Participants in the intervention group will have lower scores on the secondary outcome measures of uncertainty, cancer-specific distress, intolerance of uncertainty, and faulty beliefs about worrying, will demonstrate enhanced coping skills, and report better quality of life after treatment, as compared to a standard care control group, and these changes will be maintained at a 3-month follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fear of Cancer Recurrence Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Fear of Cancer Recurrence Intervention.
- interventionNames
- Behavioral: Fear of Cancer Recurrence Intervention
- type
- NO_INTERVENTION
- label
- Wait-list Control Group
- description
- Patients assigned to this arm will be asked to wait 6 weeks before being offered the fear of cancer recurrence intervention.
Primary outcomes (1)
- measure
- Fear of Cancer Recurrence Inventory
- timeFrame
- Up to 7 Months
- description
- The Fear of Cancer Recurrence Inventory (FCRI; Simard \& Savard, 2009) is a 42-item multidimensional instrument that has been used to examine FCR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women diagnosed with cancer (stages I-III), * English-speaking, * 18 years of age or older, * clinical level of FCR as indicated by a score of 13 or greater on the severity subscale of the FCRI (range 0-36), * clinical distress score as indicated by a score of at least 24 on the IES (range 0-75), * completion of cancer treatment, * current or previous patients of the Ottawa Hospital Cancer Centre. Exclusion Criteria: * the refusal to provide informed consent, * non-understanding of the English language, * Stage IV cancer, * previous cancer recurrence, * currently enrolled in psychotherapy for cancer issues (whether individual or group) during the treatment, * self-disclosure of unmanaged mental health disorder, * have not been a patient of the Ottawa Hospital Cancer Centre.
References
Publications (32)
- BACKGROUNDArmes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A. Patients' supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol. 2009 Dec 20;27(36):6172-9. doi: 10.1200/JCO.2009.22.5151. Epub 2009 Nov 2. PMID 19884548
- BACKGROUNDBaker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. doi: 10.1002/cncr.21488. PMID 16258929
- BACKGROUNDButow PN, Bell ML, Smith AB, Fardell JE, Thewes B, Turner J, Gilchrist J, Beith J, Girgis A, Sharpe L, Shih S, Mihalopoulos C; members of the Conquer Fear Authorship Group. Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence. BMC Cancer. 2013 Apr 23;13:201. doi: 10.1186/1471-2407-13-201. PMID 23617696
- BACKGROUNDGlynne-Jones R, Chait I, Thomas SF. When and how to discharge cancer survivors in long term remission from follow-up: the effectiveness of a contract. Clin Oncol (R Coll Radiol). 1997;9(1):25-9. doi: 10.1016/s0936-6555(97)80055-6. PMID 9039810
- BACKGROUNDGupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221. PMID 21897887
- BACKGROUNDHart SL, Latini DM, Cowan JE, Carroll PR; CaPSURE Investigators. Fear of recurrence, treatment satisfaction, and quality of life after radical prostatectomy for prostate cancer. Support Care Cancer. 2008 Feb;16(2):161-9. doi: 10.1007/s00520-007-0296-x. Epub 2007 Jul 19. PMID 17638026
- BACKGROUNDHerschbach P, Keller M, Knight L, Brandl T, Huber B, Henrich G, Marten-Mittag B. Psychological problems of cancer patients: a cancer distress screening with a cancer-specific questionnaire. Br J Cancer. 2004 Aug 2;91(3):504-11. doi: 10.1038/sj.bjc.6601986.