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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First stage intervention: eConquerFear | Experimental | 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. |
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| First stage intervention: eHealthMaintenance | Active Comparator | 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. |
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| Second stage intervention: ConquerFear-HK | Experimental | ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks. |
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| Second stage intervention: eConquerFear+eHealthMaintenance | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Ng, PhD | Contact | +852 39179897 | dwlng@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Wendy Lam, PhD | School of Public Health, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QMh department of surgery | Hong Kong | Hong Kong |
All IPD that underlie results in a publication will be available from the PI upon reasonable request.
Starting 6 months after publication
Information will be available from the PI upon reasonable request. The author to review requests is the PI.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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.
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he investigator, care provider, investigator 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 intervention or control arms.
The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
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| 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. |
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| ConquerFear | Behavioral | ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions. |
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| eConquerFear+eHealthMaintenance | Behavioral | The combination of eConquerFear and eHealthMaintenance interventions, that consists of 10 weekly online modules. |
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| 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 |