Fear of Cancer Recurrence Clinical Trial
Official title:
The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial
NCT number | NCT04568226 |
Other study ID # | UW19-183 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 21, 2021 |
Est. completion date | February 3, 2024 |
Verified date | June 2024 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 177 |
Est. completion date | February 3, 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kwong Wah Hospital-Breast Center | Hong Kong | |
Hong Kong | Prince of Wales Hospital-Department of Surgery | Hong Kong | |
Hong Kong | Queen Mary Hospital-Department of Obstetrics & Gynaecology | Hong Kong | |
Hong Kong | Queen Mary Hospital-Department of Surgery | Hong Kong | |
Hong Kong | The University of Hong Kong Jockey Club Institute of Cancer Care | Hong Kong | |
Hong Kong | Tung Wah Hospital-Department of Surgery | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Research Grants Council, Hong Kong |
Hong Kong,
Butow 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. — View Citation
Ng 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. — View Citation
Ng 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic data | Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire | Baseline | |
Other | Clinical data | Clinical data will be extracted from medical records. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Primary | Fear of cancer recurrence | The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Metacognitions | The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style. | Baseline, immediate post-intervention, 3months post-intervention, and 6months | |
Secondary | EORTC QLQ-C30 | Quality of life (QoL) will be assessed by the EORTC QLQ-C30, in which incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Self-efficacy | Self-efficacy for managing chronic disease will be assessed using the Self-Efficacy for Managing Chronic Disease 6-item Scale. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Coping behavior | Coping behavior will be assessed using the 28-item Chinese Brief COPE. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Experimental avoidance | Experimental avoidance will be assessed using the Acceptance and action questionnaire. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Cognitive Attentional Syndrome | Cognitive Attentional Syndrome (CAS) will be assessed using the Cognitive-attentional Syndrome questionnaire (CAS-1). | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Intolerance of uncertainty | Intolerance of uncertainty (IU) will be assessed using the 12-item Intolerance of uncertainty-12. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Psychological distress | Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item measure of anxiety and depression widely used to assess cancer-related distress. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Cancer-related distress | The 22-item Chinese Impact of Events Scale-revised (CIES-R) will be used to assess cancer-related distress, which comprised three subscales: avoidance, intrusive thoughts and hyperarousal symptoms measured using 5-point Likert scales. Higher mean scores on each subscale indicate greater avoidance/intrusiveness/arousal. | Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention | |
Secondary | Treatment expectancy | Treatment expectancy will be assessed using the 6-item credibility/ expectancy questionnaire. | Baseline and immediate post-intervention | |
Secondary | Therapeutic alliance | The 12-item Working Alliance Inventory (WAI-SF)will be used to assess agreement on the therapy goal, patients' agreement with the therapist, and quality of the interpersonal bond. Both the participants and therapists will be asked to fill in the WAI-SF immediate post-intervention | Immediate post-intervention | |
Secondary | Treatment satisfaction | Treatment satisfaction will be assessed using the evaluation form. Participants will be asked to indicate their overall satisfaction with the intervention they have received. | Immediate post-intervention |
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