The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence

Not Applicable

Completed

• Conditions: Fear of Cancer Recurrence
• Interventions: Other: ConquerFear Intervention

• Registration Number: NCT04568226
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

A randomized controlled trial will be conducted to test the effect of a metacognition-based manualized intervention on fear of cancer recurrence among Chinese breast, gynecologic and colorectal cancer patients with high levels of fear of cancer recurrence.

The aims are to test:

1. the direct effect of ConquerFear intervention on fear of cancer recurrence,

2. the direct effect of ConquerFear intervention on maladaptive metacognition

3. the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Primary hypothesis:

1. Participants in the ConquerFear intervention will show a greater reduction in fear of cancer recurrence compared to participants in the control group

2. Participants in the ConquerFear intervention will show a greater reduction in maladaptive metacognition than the control participants

3. There will be an indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-27
• Study First Posted: 2020-09-29
• Study Start: 2021-07-21
• Primary Completion: 2023-09-30
• Study Completion: 2024-02-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ConquerFear Intervention	ConquerFear Intervention	Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.

Primary Outcome Measures

Name	Time	Method
Fear of cancer recurrence	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	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.
Cognitive Attentional Syndrome	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	Cognitive Attentional Syndrome (CAS) will be assessed using the Cognitive-attentional Syndrome questionnaire (CAS-1).
Psychological distress	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	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.
Treatment satisfaction	Immediate post-intervention	Treatment satisfaction will be assessed using the evaluation form. Participants will be asked to indicate their overall satisfaction with the intervention they have received.
Metacognitions	Baseline, immediate post-intervention, 3months post-intervention, and 6months	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.
Self-efficacy	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	Self-efficacy for managing chronic disease will be assessed using the Self-Efficacy for Managing Chronic Disease 6-item Scale.
Coping behavior	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	Coping behavior will be assessed using the 28-item Chinese Brief COPE.
Experimental avoidance	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	Experimental avoidance will be assessed using the Acceptance and action questionnaire.
Cancer-related distress	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	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.
Treatment expectancy	Baseline and immediate post-intervention	Treatment expectancy will be assessed using the 6-item credibility/ expectancy questionnaire.
Therapeutic alliance	Immediate post-intervention	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
Intolerance of uncertainty	Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention	Intolerance of uncertainty (IU) will be assessed using the 12-item Intolerance of uncertainty-12.

Trial Locations

Locations (6)

Kwong Wah Hospital-Breast Center; 🇭🇰 Hong Kong, Hong Kong

The University of Hong Kong Jockey Club Institute of Cancer Care; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital-Department of Surgery; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital-Department of Surgery; 🇭🇰 Hong Kong, Hong Kong

Tung Wah Hospital-Department of Surgery; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital-Department of Obstetrics & Gynaecology; 🇭🇰 Hong Kong, Hong Kong