E-intervention on Subclinical Fear of Cancer Recurrence

N/ARecruitingNCT06207006

The University of Hong Kong48 enrolled

Overview

The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer recurrence.

A pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear of cancer recurrence. The following hypotheses will be tested: 1. There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group. 2. There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group. 3. There will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group. 4. Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention. 5. Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cancer Psychooncology Fear of Cancer Recurrence

Interventions

eConquerFear-HKBEHAVIORAL

The key goals of the 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.

Basic Cancer CareBEHAVIORAL

Basic Cancer Care serves as an active comparator and 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cantonese- or Mandarin-speaking Chinese cancer survivors * recently diagnosed with potentially curable (stage 0 to III) colorectal or breast cancer * had recently completed surgery as primary treatment * have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months * scored 13 to 21 on the fear of cancer recurrence-short form will be recruited. Exclusion Criteria: * non-Chinese ethnicity * metastatic cancer * with current diagnosis of depression or psychosis or are currently receiving psychological treatments * language or intellectual difficulties that prevent them from understanding the intervention content * having limited or no Internet access.

Locations (1)

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

Rate of subject recruitment

number of participants consent and being randomized/number of eligible patients x 100

Time frame: baseline

Rate of subject retention

number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100

Time frame: baseline,3-months post-intervention and 6-months post-intervention

Adherence rate to intervention

number of participants who complete the intervention/number of being allocated to attend the intervention x 100

Time frame: the immediate post-intervention

Intervention utility

Intervention utility will be assessed using the site use metrics, including total number of log-ins

Time frame: the immediate post-intervention

Acceptability of the intervention

Acceptability of the intervention will be assessed using the 22-item measure, which was adopted from the 31-item measure designed to assess the general views on the presentation and content of information in a decision aid intervention for treatment decision making. It assess the comprehensibility of the intervention content and also its utility using 4- (1 = "Poor"; 2 = "Fair"; 3 = "Good"; 4 = "Excellent") or 5-option (1 ="strongly disagree"; 5 = "strongly agree") categorical responses, respectively. Higher scores indicate better acceptability.

Time frame: the immediate post-intervention

Change of fear of cancer recurrence

Fear of cancer recurrence. FCR will be assessed using the Chinese 42-item Fear of Cancer Recurrence Inventory (FCRI) at four assessment points (T0-T3).(5) FCRI comprises seven subscales: trigger, severity, psychological distress, functional impairment, reassurance, insights and coping strategies measured using 5-point Likert scales (0 = "never"; 4 = " a great deal or all the time").(5) Total scores range from 0 to 168; with higher scores indicating higher FCR.

Central Contacts

Danielle Ng, PhD

CONTACT

39179897 dwlng@hku.hk

Data from ClinicalTrials.gov

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Secondary Outcomes

Change of quality of life

Quality of life will be measured by the Chinese version of the 30-item European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), consisting of five functional subscales (physical, role, emotional, cognitive, and social functioning), three symptom subscales (pain, fatigue and nausea/vomiting), a global health subscale, five single symptom items (e.g., sleep disturbance, dyspnea, appetite loss, constipation, and diarrhea), and an single item for financial difficulty. The score range is 0-100. High scores on the functional and global health subscales indicate better functioning and QoL, respectively. High scores on the symptom subscale or item indicate more symptom(s).

Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Change of general psychological distress

e Chinese 14-item Hospital Anxiety and Depression Scale (HADS),(21) comprising two 7-item subscales that measure anxiety and depression. Each subscale total scores range from 0 to 21 with higher scores suggesting higher distress.

Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Attitude towards internet assessed using categorical Likert scales

Attitude towards internet will be assessed using a 6 points-categorical Likert scale (0-5) asking if they find internet easy to use. Higher scores indicate more positive attitude towards internet.

Time frame: the immediate post-intervention

Treatment satisfaction

A 17-item treatment satisfaction questionnaire, originally designed to evaluate overall satisfaction with the intervention in our current RCT of ConquerFear-HK, will be used. The first 9 items will be assessed using a 5 points-categorical Likert scale (1-5) Higher scores indicate higher satisfaction. The remaining questions are open-questions.

Time frame: the immediate post-intervention

Change of metacognition

Metacognition will be assessed at T0-T3 using the 30-item Metacognitions Questionnaire- 30 (MCQ-30), consisting of five subscales assessing Positive beliefs about worry, Negative beliefs about worry, Cognitive Self-Consciousness, Cognitive Confidence, and Need to control thoughts. A 4 points-categorical Likert scale (1-4) will be used. Higher scores indicate worse metacognition

Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention