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

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Cancer; Fear of Cancer Recurrence

Treatments: Behavioral: eConquerFear+eHealthMaintenance; Behavioral: eConquerFear; Behavioral: ConquerFear; Behavioral: eHealthMaintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT06181331

FCR-SMART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups

First stage intervention: eConquerFear

Experimental group

Description:

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.

Treatment:

Behavioral: eConquerFear

First stage intervention: eHealthMaintenance

Active Comparator group

Description:

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.

Treatment:

Behavioral: eHealthMaintenance

Second stage intervention: ConquerFear-HK

Experimental group

Description:

ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks.

Treatment:

Behavioral: ConquerFear

Second stage intervention: eConquerFear+eHealthMaintenance

Active Comparator group

Description:

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.

Treatment:

Behavioral: eConquerFear+eHealthMaintenance