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

ConditionsCancerFear of Cancer Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: First stage intervention: eConquerFearExperimental treatment 1 intervention
Group B: First stage intervention: eHealthMaintenanceActive comparator 1 intervention
Group C: Second stage intervention: ConquerFear-HKExperimental treatment 1 intervention
Group D: Second stage intervention: Group-delivered ConquerFear-HKActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of fear of cancer recurrence (FCR)

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.

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

Secondary outcomes

1

Change of metacognitions

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.

Time frame
baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
2

Change of cognitive attentional syndrome

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.

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

Other outcomes

Sponsors and contacts

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The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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