The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eConquerFear, eHealthMaintenance, ConquerFear, eConquerFear+eHealthMaintenance.
- Who it may be relevant to
- Registry conditions: Cancer, Fear of Cancer Recurrence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)
Overview
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
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.
Interventions
- Behavioral eConquerFear
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. - Behavioral eHealthMaintenance
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. - Behavioral ConquerFear
ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions. - Behavioral eConquerFear+eHealthMaintenance
The combination of eConquerFear and eHealthMaintenance interventions, that consists of 10 weekly online modules.
Primary outcome measures
- Change of fear of cancer recurrence (FCR) [Time frame: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention]
Secondary outcome measures (2)
- Change of metacognitions [Time frame: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention]
- Change of cognitive attentional syndrome [Time frame: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- QMh department of surgery — Hong Kong
Identifiers
NCT: NCT06181331 · FCR-SMART