NCT06181331

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cancer
• Fear of Cancer Recurrence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-12-26
• Last updated: 2025-06-11

Locations

1 site across 1 country: Hong Kong