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NCT Number: NCT06181331

The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence

A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.

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Key information

Conditions

Cancer Fear of Cancer Recurrence Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The current SMART trial aims to address the following research questions and hypotheses:

  • What is the best initial low-intensity unsupervised self-guided e-intervention for managing subclinical FCR? Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance. This hypothesis will address the main effect of the first-stage intervention.
  • What is the best treatment option for non-respondents to initial adaptive interventions? Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, individual, face-to-face ConquerFear than to group-delivered ConquerFear. This hypothesis will address the main effect of the second-stage intervention.
  • Which of the four embedded adaptive interventions (1. eConquerFear + group-delivered ConquerFear; 2. eConquerFear + Individual ConquerFear; 3. eHealthMaintenance + group-delivered ConqerFear; 4. eHealthMaintenance + Individual ConquerFear) leads to the greatest reduction in FCR? Hypothesis 3: eConquerFear + Individual ConquerFear will lead to the greatest reduction in FCR. This hypothesis will identify the best adaptive intervention.
  • Given that the ConquerFear intervention aims to modify unhelpful metacognitive beliefs and cognitive-attentional syndrome (CAS), we will test if the effect of stepped-care ConquerFear intervention on FCR is mediated by its effect on maladaptive metacognition and CAS. We hypothesize that there would be an indirect effect of stepped-care ConquerFear intervention on FCR through its effect on maladaptive metacognition and CAS (Hypothesis 4).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included.

Exclusion criteria

  • Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.

Treatment and study plan

eConquerFear

Behavioral

The key goals of this e-intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting.

eHealthMaintenance

Behavioral

eHealthMaintenance is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge.

ConquerFear

Behavioral

ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.

Group-delivered ConquerFear-HK

Behavioral

Group-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention.

Primary outcomes

  1. Change of fear of cancer recurrence (FCR)

    Time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).

    The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.

Secondary outcomes

  1. Change of metacognitions

    Time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).

    Metacognition assessed by the 30-item Metacognitions Questionnaire (MCQ). The MCQ assesses individual differences in metacognitive beliefs, judgements, and monitoring tendencies across five domains: (1) positive beliefs about worry, (2) negative beliefs about thoughts concerning uncontrollability and danger, (3) cognitive confidence, (4) cognitive self-consciousness, and (5) the need to control thoughts. All items are rated on a 4-point Likert scale ranging from 1 (do not agree) to 4 (agree very much). Higher scores indicate higher levels of maladaptive metacognition.

  2. Change of cognitive attentional syndrome

    Time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).

    CAS measured by the 16-item Cognitive Attentional Syndrome-1 (CAS-1) questionnaire.The CAS-1 assesses the frequency of engaging in rumination, threat monitoring, and coping behaviors, as well as the level of metacognitive beliefs. Each item is rated on a 9-point Likert scale ranging from 0 to 8, except for items measuring metacognitive beliefs, which are rated on a scale from 0 to 100. Higher scores indicate higher levels of CAS activation.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Ng, PhD

CONTACT

[email protected]

+852 39179897

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2023
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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