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Fear of Cancer RecurrenceNCT04568226

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

A study testing ConquerFear Intervention in people with Fear of Cancer Recurrence, run by The University of Hong Kong at 6 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fear of Cancer Recurrence
What is being tested?
ConquerFear Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
6 sitesHong Kong
Study dates
21 Jul 2021to 3 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Hong Kong6 sites

  • Queen Mary Hospital-Department of Surgery

    Hong Kong, 000

  • Kwong Wah Hospital-Breast Center

    Hong Kong

  • Prince of Wales Hospital-Department of Surgery

    Hong Kong

  • Queen Mary Hospital-Department of Obstetrics & Gynaecology

    Hong Kong

  • The University of Hong Kong Jockey Club Institute of Cancer Care

    Hong Kong

  • Tung Wah Hospital-Department of Surgery

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial

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.

Read the 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.
Being tested
ConquerFear Intervention, Active control: Basic Cancer Care
Keywords
Fear of cancer recurrence, Metacognition, Cancer survivorship, Psychooncology, Breast cancer, Colorectal cancer, Gynecologic cancer
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConquerFear InterventionOther

    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.

  • Active control: Basic Cancer CareOther

    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.

Study groups in NCT04568226
Study groupRoleWhat they receive
ConquerFear InterventionExperimentalParticipants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.
Receives: Other: ConquerFear Intervention
Basic Cancer CareActive comparatorBasic 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.
Receives: Other: Active control: Basic Cancer Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)

  1. 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.

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

  2. 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.

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

  3. Self-efficacy

    Self-efficacy for managing chronic disease will be assessed using the Self-Efficacy for Managing Chronic Disease 6-item Scale.

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

  4. Coping behavior

    Coping behavior will be assessed using the 28-item Chinese Brief COPE.

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

  5. Experimental avoidance

    Experimental avoidance will be assessed using the Acceptance and action questionnaire.

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

  6. Cognitive Attentional Syndrome

    Cognitive Attentional Syndrome (CAS) will be assessed using the Cognitive-attentional Syndrome questionnaire (CAS-1).

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

  7. Intolerance of uncertainty

    Intolerance of uncertainty (IU) will be assessed using the 12-item Intolerance of uncertainty-12.

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

  8. 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.

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

  9. 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.

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

  10. Treatment expectancy

    Treatment expectancy will be assessed using the 6-item credibility/ expectancy questionnaire.

    Measured: Baseline and immediate post-intervention

  11. 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

    Measured: Immediate post-intervention

  12. 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.

    Measured: Immediate post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start21 Jul 2021
  3. Primary completion30 Sep 2023
  4. Study completion3 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568226
Sponsor's protocol ID
UW19-183
Status last verified
Jun 2024
First submitted
22 Sep 2020
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication will be available from the PI upon reasonable request.

Publications

  • 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.

    PubMed 31663187

  • 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.

    PubMed 30932279

  • 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.

    PubMed 29095681

  • 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.

    PubMed 40784346

  • 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.

    PubMed 36669845

Questions about this trial

What is this clinical trial studying?

A study testing ConquerFear Intervention in people with Fear of Cancer Recurrence, run by The University of Hong Kong at 6 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of cancer recurrence (time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568226, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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