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

Study Overview
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Brief Summary
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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.

Detailed Description
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The current SMART trial aims to address the following hypotheses: Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance. Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, face-to-face ConquerFear than to augment eConquerFear with eHealthMaintenance. Hypothesis 3: eConquerFear + ConquerFear will lead to the greatest reduction in fear of cancer recurrence. Hypothesis 4: There would be an indirect effect of stepped-care ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition and cognitive attentional syndrome.

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

Conditions
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Cancer, Fear of Cancer Recurrence

Intervention / Treatment
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* Behavioral: eConquerFear
* Behavioral: eHealthMaintenance
* Behavioral: ConquerFear
* Behavioral: eConquerFear+eHealthMaintenance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: First stage intervention: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the eConquerFear or eHealthMaintenance Second stage intervention for non-respondents: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the augment eConquerFear with eHealthMaintenance (or vice versa) versus switch to supervised, face-to-face ConquerFear intervention.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First stage intervention: eConquerFear<br>Participants in the eConquerFear intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention. | Behavioral: eConquerFear<br>* 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.<br>|
| Active Comparator: First stage intervention: eHealthMaintenance<br>Participants in the eHealthMaintenance group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term. | Behavioral: eHealthMaintenance<br>* 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.<br>|
| Experimental: Second stage intervention: ConquerFear-HK<br>ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks. | Behavioral: ConquerFear<br>* ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.<br>|
| Active Comparator: Second stage intervention: eConquerFear+eHealthMaintenance<br>The augmented eConquerFear + eHealthMaintenance intervention is a combined unsupervised, self-guided web-based intervention that consists of 10 weekly online modules covering the content of eConquerFear and eHealthMaintenance interventions. | Behavioral: eConquerFear+eHealthMaintenance<br>* The combination of eConquerFear and eHealthMaintenance interventions, that consists of 10 weekly online modules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention | 
| 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. | baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sequential multiple assessment randomized controlled trial, stepped-up care, psychooncology