Clinical trial · Interventional
The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence
The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial
NCT04568226CI-TRIAL-00078024completedN/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)
The primary aim of this study is to assess the effect of ConquerFear, a metacognition-based manualized intervention on fear of cancer recurrence, using the randomized controlled trial approach, among Chinese patients newly diagnosed with curable cancer. This study aims to (1) test the direct effect of ConquerFear intervention on fear of cancer recurrence and on maladaptive metacognition, and (2) to test the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.
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 |
|---|---|---|---|
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active control: Basic Cancer Care | Other | — | UNRESOLVED |
| ConquerFear Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ConquerFear Intervention
- description
- Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.
- interventionNames
- Other: ConquerFear Intervention
- type
- ACTIVE_COMPARATOR
- label
- Basic Cancer Care
- description
- Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.
- interventionNames
- Other: Active control: Basic Cancer Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with non-metastatic breast cancer, gynecologic cancer, or colorectal cancer 2. had surgery as a primary treatment 3. have had completed hospital-based adjuvant treatments including radiotherapy and chemotherapy within the past 18 months 4. with the cut-off scored ≥ 13 on Severity, the subscale of Fear of cancer inventory 5. are able to read and write Chinese 6. are over the age of 18 years Exclusion Criteria: 1. non-Chinese ethnicity 2. Patients diagnosed with metastatic cancer 3. with a current diagnosis of depression or psychosis 4. currently receiving psychological treatment 5. with language difficulties or intellectual disability.
References
Publications (5)
- BACKGROUNDNg DWL, Foo CC, Ng SSM, Kwong A, Suen D, Chan M, Or A, Chun OK, Fielding BFS, Lam WWT. The role of metacognition and its indirect effect through cognitive attentional syndrome on fear of cancer recurrence trajectories: A longitudinal study. Psychooncology. 2020 Feb;29(2):271-279. doi: 10.1002/pon.5234. Epub 2019 Dec 23. PMID 31663187
- BACKGROUNDNg DWL, Kwong A, Suen D, Chan M, Or A, Ng SS, Foo CC, Fielding BFS, Lam WWT. Fear of cancer recurrence among Chinese cancer survivors: Prevalence and associations with metacognition and neuroticism. Psychooncology. 2019 Jun;28(6):1243-1251. doi: 10.1002/pon.5073. Epub 2019 Apr 26. PMID 30932279
- BACKGROUNDButow PN, Turner J, Gilchrist J, Sharpe L, Smith AB, Fardell JE, Tesson S, O'Connell R, Girgis A, Gebski VJ, Asher R, Mihalopoulos C, Bell ML, Zola KG, Beith J, Thewes B. Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. J Clin Oncol. 2017 Dec 20;35(36):4066-4077. doi: 10.1200/JCO.2017.73.1257. Epub 2017 Nov 2. PMID 29095681
- DERIVEDNg DWL, Ng R, Guo C, Chan J, Fielding R, Tang JWC, Li WWY, Foo CC, Kwong A, Ng SS, Suen D, Fung S, Chun OK, Chan KKL, Chang ATY, Butow P, Lam WWT. ConquerFear-HK: A Randomized Controlled Trial of a Metacognition-Based, Manualized Intervention for Fear of Cancer Recurrence among Chinese Cancer Survivors. Psychother Psychosom. 2026;95(2):117-133. doi: 10.1159/000547888. Epub 2025 Aug 8. PMID 40784346
- DERIVEDNg DWL, Fielding R, Tsang C, Ng C, Chan J, Or A, Kong IWM, Tang JWC, Li WWY, Chang ATY, Foo CC, Kwong A, Ng SS, Suen D, Chan M, Chun OK, Chan KKL, Butow PN, Lam WWT. Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors. BMJ Open. 2023 Jan 20;13(1):e065075. doi: 10.1136/bmjopen-2022-065075. PMID 36669845