Clinical trial NCT06181331: The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence
Official title: The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Fear of Cancer Recurrence
Keywords: Sequential multiple assessment randomized controlled trial
stepped-up care
psychooncology
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Change of fear of cancer recurrence (FCR)
timeFrame: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention
Secondary outcomes:
measure: Change of metacognitions
timeFrame: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention
measure: Change of cognitive attentional syndrome
timeFrame: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention
Other outcomes:
Locations:
city: Hong kong
country: Hong Kong
facility: QMh department of surgery
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: