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| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
| Koo Foundation Sun Yat-Sen Cancer Center | OTHER |
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The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses' health education and information for those having a lower level of concern. Those who have medium or higher levels of concerns will be randomized to receive "stepping up" either a "ConquerFear psychological cognitive training" or a "healthy lifestyle - individualized exercise and nutrition guidance".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| education group | Active Comparator | one session of nurses' education and information |
|
| ConquerFear group | Experimental | a 6-session add-on psychological cognitive training performed by a trained psychologist |
|
| Healthy lifestyle group | Experimental | a 6-session add-on individualized nutrition and exercise guidance performed by a trained nutritionist and an exercise expert. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psycological cognitive training | Behavioral | Metacognition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fear of Cance Recurrence | the change of FCR (Fear of Cancer Recurrence) score as measured by FCRI | From the baseline to the 3 months after intervention at 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological distress | the change of the anxiety and depression as measured by HADS | From the baseline to the 3 months after intervention at 5 months |
| QOL | The change of the quality of life score as measured by VR-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Metacognition | the change of metacognition as measured by MCQ-30 | From the baseline to the 3 month after intervention at 5 months |
| Intervention Satisfaction | the score of self-designed satisfaction score with the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiuyu C. Katie Lee | Contact | 886961395150 | shiuyu@ntunhs.edu.tw | |
| Shiao-Wei Cheng | Contact | 886919885149 | study1042@ntunhs.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Shiuyu C. Katie Lee, PhD | National Taipei University of Nursing and Health Science | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35227244 | Background | Park SY, Lim JW. Cognitive behavioral therapy for reducing fear of cancer recurrence (FCR) among breast cancer survivors: a systematic review of the literature. BMC Cancer. 2022 Feb 28;22(1):217. doi: 10.1186/s12885-021-08909-y. | |
| 40784346 | Background | Ng 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. |
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It is restricted by the sponsors.
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Based on screening levels of fear of cancer recurrence (FCR), those with lower FCR will receive only education, and those with medium or higher FCR will be randomized to one of two add-on psychological cognitive training or individualized healthy lifestyle guidance groups in parallel for the duration of the study.
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| Healthy lifestyle | Behavioral | individualized nutrition and exercise guidance |
|
|
| education | Behavioral | FCR education |
|
| From the baseline to the 3 months after intervention at 5 months |
| at the end of intervention at 2 month |