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

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

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.

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.