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

NCT04568226 | Completed

• 1 other identifier: UW19-183
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 6

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.

Conditions

Fear of Cancer Recurrence

Keywords

Fear of cancer recurrence; Metacognition; Cancer survivorship; Psychooncology; Breast cancer; Colorectal cancer; Gynecologic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Metacognitions

  Baseline, immediate post-intervention, 3months post-intervention, and 6months

• EORTC QLQ-C30

  Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention

• Self-efficacy

  Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention

• Coping behavior

  Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention

• Experimental avoidance

  Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention

Other Outcomes (2)

• Demographic data

  Baseline

• Clinical data

  Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention

Study Arms (2)

ConquerFear Intervention

EXPERIMENTAL

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

Other: ConquerFear Intervention

Basic Cancer Care

ACTIVE COMPARATOR

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.

Other: Active control: Basic Cancer Care

Interventions

ConquerFear Intervention OTHER

ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19). Each session will last 60-90 minutes and be delivered by a trained therapist. After each session, participants will be given home-based exercises to practice the skills learned in the sessions. With the uncertainty surrounding the COVID-19 pandemic, instead of face-to-face sessions only, a hybrid mode of intervention delivery will be used by offering participants the choice of face-to-face or online sessions.

ConquerFear Intervention

Active control: Basic Cancer Care OTHER

Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar to the ConquerFear intervention, Basic Cancer Care intervention consists of 6 individual sessions over 10 weeks. Each session will last 60-90 minutes and be delivered by a trained therapist, a registered dietitian, and an exercise physiologist, respectively. A hybrid mode of intervention delivery will be also used by offering participants the choice of face-to-face or online sessions.

Basic Cancer Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with non-metastatic breast cancer, gynecologic cancer, or colorectal cancer
• had surgery as a primary treatment
• have had completed hospital-based adjuvant treatments including radiotherapy and chemotherapy within the past 18 months
• with the cut-off scored ≥ 13 on Severity, the subscale of Fear of cancer inventory
• are able to read and write Chinese
• are over the age of 18 years

You may not qualify if:

• non-Chinese ethnicity
• Patients diagnosed with metastatic cancer
• with a current diagnosis of depression or psychosis
• currently receiving psychological treatment
• with language difficulties or intellectual disability.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Research Grants Council, Hong Kong: collaborator

Study Sites (6)

Queen Mary Hospital-Department of Surgery

Hong Kong, 000, Hong Kong

Location

Kwong Wah Hospital-Breast Center

Hong Kong, Hong Kong

Location

Prince of Wales Hospital-Department of Surgery

Hong Kong, Hong Kong

Location

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, Hong Kong

Location

The University of Hong Kong Jockey Club Institute of Cancer Care

Hong Kong, Hong Kong

Location

Tung Wah Hospital-Department of Surgery

Hong Kong, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 31663187 BACKGROUND

• 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.

  PMID: 30932279 BACKGROUND

• 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.

  PMID: 29095681 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. 2025 Aug 8:1-17. doi: 10.1159/000547888. Online ahead of print.

  PMID: 40784346 DERIVED

• Ng 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Wendy Wing Tak Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to ConquerFear or control arms. The participants are masked in terms of not knowing that one intervention (i.e. Conquer fear) is hypothesized to yield larger effects than the other (i.e. control).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will use a block randomization structure with randomly permuted block sizes of 2,4, and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias. We will also use a block randomization structure with randomly permuted block sizes of 4 and 8 to ensure an equal case allocation to each therapist. We will also use a block randomization structure with randomly permuted block sizes of 2,4, and 6 to ensure an equal case allocation to each dietitian.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 29, 2020
• Study Start: July 21, 2021
• Primary Completion: September 30, 2023
• Study Completion: February 3, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (6)