Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

Not Applicable

Recruiting

• Conditions: Fear of Cancer Progression; Advanced or Metastatic Cancer; Metacognition-based Intervention; Supportive-expressive Based Intervention; Psychooncology
• Interventions: Behavioral: ConquerFear intervention; Behavioral: CALM intervention; Behavioral: Basic Cancer Care

• Registration Number: NCT05679518
• Lead Sponsor: The University of Hong Kong

Brief Summary

The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

Detailed Description

A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

The aims are to test:

1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and

2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Primary hypothesis:

1. Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression.

2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.

3. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-23
• Study First Posted: 2023-01-11
• Study Start: 2023-12-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer
• are the age of 18 years or above

Exclusion Criteria

• Patients with major communication difficulties
• are being unwilling or unable to commit 6 psychotherapy sessions

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.
CALM intervention	CALM intervention	Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.
Basic Cancer Care	Basic Cancer Care	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.

Primary Outcome Measures

Name	Time	Method
Fear of Progression	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention	The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.

Secondary Outcome Measures

Name	Time	Method
Metacognitions	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention	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.
Depression	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention	Change in total scores of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, with higher scores indicative of a higher level of depression. The PHQ-9 is a reliable and valid 9-item measure of depression that has been used widely in advanced cancer patients.
Death anxiety	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention	Change in total scores of death anxiety will be assessed by the 15-item Death and Dying Distress Scale (DDDS). The DDS score can range from 0 to 90, with higher scores indicative of a higher level of death anxiety.

Trial Locations

Locations (4)

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