Cancer, Fear of Cancer Recurrence
Conditions
Keywords
Sequential multiple assessment randomized controlled trial, stepped-up care, psychooncology
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 research questions and hypotheses: 1. What is the best initial low-intensity unsupervised self-guided e-intervention for managing subclinical FCR? Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance. This hypothesis will address the main effect of the first-stage intervention. 2. What is the best treatment option for non-respondents to initial adaptive interventions? Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, individual, face-to-face ConquerFear than to group-delivered ConquerFear. This hypothesis will address the main effect of the second-stage intervention. 3. Which of the four embedded adaptive interventions (1. eConquerFear + group-delivered ConquerFear; 2. eConquerFear + Individual ConquerFear; 3. eHealthMaintenance + group-delivered ConqerFear; 4. eHealthMaintenance + Individual ConquerFear) leads to the greatest reduction in FCR? Hypothesis 3: eConquerFear + Individual ConquerFear will lead to the greatest reduction in FCR. This hypothesis will identify the best adaptive intervention. 4. Given that the ConquerFear intervention aims to modify unhelpful metacognitive beliefs and cognitive-attentional syndrome (CAS), we will test if the effect of stepped-care ConquerFear intervention on FCR is mediated by its effect on maladaptive metacognition and CAS. We hypothesize that there would be an indirect effect of stepped-care ConquerFear intervention on FCR through its effect on maladaptive metacognition and CAS (Hypothesis 4).
Interventions
BEHAVIORALeConquerFear
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.
BEHAVIORALeHealthMaintenance
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.
BEHAVIORALConquerFear
ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.
BEHAVIORALGroup-delivered ConquerFear-HK
Group-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigator, care provider, investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or control arms. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
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 supervised, face-to-face ConquerFear intervention Vs group-delivered ConquerFear intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of fear of cancer recurrence (FCR) | baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3). | The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of metacognitions | baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3). | Metacognition assessed by the 30-item Metacognitions Questionnaire (MCQ). The MCQ assesses individual differences in metacognitive beliefs, judgements, and monitoring tendencies across five domains: (1) positive beliefs about worry, (2) negative beliefs about thoughts concerning uncontrollability and danger, (3) cognitive confidence, (4) cognitive self-consciousness, and (5) the need to control thoughts. All items are rated on a 4-point Likert scale ranging from 1 (do not agree) to 4 (agree very much). Higher scores indicate higher levels of maladaptive metacognition. |
| Change of cognitive attentional syndrome | baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3). | CAS measured by the 16-item Cognitive Attentional Syndrome-1 (CAS-1) questionnaire.The CAS-1 assesses the frequency of engaging in rumination, threat monitoring, and coping behaviors, as well as the level of metacognitive beliefs. Each item is rated on a 9-point Likert scale ranging from 0 to 8, except for items measuring metacognitive beliefs, which are rated on a scale from 0 to 100. Higher scores indicate higher levels of CAS activation. |
Countries
Hong Kong
Contacts
CONTACTDanielle Ng, PhD
PRINCIPAL_INVESTIGATORWendy Lam, PhD
School of Public Health, The University of Hong Kong
Outcome results
None listed