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NCT Number: NCT04568226

The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence

The primary aim of this study is to assess the effect of ConquerFear, a metacognition-based manualized intervention on fear of cancer recurrence, using the randomized controlled trial approach, among Chinese patients newly diagnosed with curable cancer. This study aims to (1) test the direct effect of ConquerFear intervention on fear of cancer recurrence and on maladaptive metacognition, and (2) to test the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

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Key information

Conditions

Fear of Cancer Recurrence Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital-Breast Center, Hong Kong

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About this study

A randomized controlled trial will be conducted to test the effect of a metacognition-based manualized intervention on fear of cancer recurrence among Chinese breast, gynecologic and colorectal cancer patients with high levels of fear of cancer recurrence.

The aims are to test:

  • the direct effect of ConquerFear intervention on fear of cancer recurrence,
  • the direct effect of ConquerFear intervention on maladaptive metacognition
  • the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Primary hypothesis:

  • Participants in the ConquerFear intervention will show a greater reduction in fear of cancer recurrence compared to participants in the control group
  • Participants in the ConquerFear intervention will show a greater reduction in maladaptive metacognition than the control participants
  • There will be an indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with non-metastatic breast cancer, gynecologic cancer, or colorectal cancer
  • had surgery as a primary treatment
  • have had completed hospital-based adjuvant treatments including radiotherapy and chemotherapy within the past 18 months
  • with the cut-off scored ≥ 13 on Severity, the subscale of Fear of cancer inventory
  • are able to read and write Chinese
  • are over the age of 18 years

Exclusion criteria

  • non-Chinese ethnicity
  • Patients diagnosed with metastatic cancer
  • with a current diagnosis of depression or psychosis
  • currently receiving psychological treatment
  • with language difficulties or intellectual disability.

Treatment and study plan

ConquerFear Intervention

Other

ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19). Each session will last 60-90 minutes and be delivered by a trained therapist. After each session, participants will be given home-based exercises to practice the skills learned in the sessions. With the uncertainty surrounding the COVID-19 pandemic, instead of face-to-face sessions only, a hybrid mode of intervention delivery will be used by offering participants the choice of face-to-face or online sessions.

Active control: Basic Cancer Care

Other

Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar to the ConquerFear intervention, Basic Cancer Care intervention consists of 6 individual sessions over 10 weeks. Each session will last 60-90 minutes and be delivered by a trained therapist, a registered dietitian, and an exercise physiologist, respectively. A hybrid mode of intervention delivery will be also used by offering participants the choice of face-to-face or online sessions.

Primary outcomes

  1. Fear of cancer recurrence

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

    The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.

Secondary outcomes

  1. Metacognitions

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

    The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style.

  2. EORTC QLQ-C30

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

    Quality of life (QoL) will be assessed by the EORTC QLQ-C30, in which incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.

  3. Self-efficacy

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

    Self-efficacy for managing chronic disease will be assessed using the Self-Efficacy for Managing Chronic Disease 6-item Scale.

  4. Coping behavior

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

    Coping behavior will be assessed using the 28-item Chinese Brief COPE.

  5. Experimental avoidance

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

    Experimental avoidance will be assessed using the Acceptance and action questionnaire.

  6. Cognitive Attentional Syndrome

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

    Cognitive Attentional Syndrome (CAS) will be assessed using the Cognitive-attentional Syndrome questionnaire (CAS-1).

  7. Intolerance of uncertainty

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

    Intolerance of uncertainty (IU) will be assessed using the 12-item Intolerance of uncertainty-12.

  8. Psychological distress

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

    Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item measure of anxiety and depression widely used to assess cancer-related distress.

  9. Cancer-related distress

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

    The 22-item Chinese Impact of Events Scale-revised (CIES-R) will be used to assess cancer-related distress, which comprised three subscales: avoidance, intrusive thoughts and hyperarousal symptoms measured using 5-point Likert scales. Higher mean scores on each subscale indicate greater avoidance/intrusiveness/arousal.

  10. Treatment expectancy

    Time frame: Baseline and immediate post-intervention

    Treatment expectancy will be assessed using the 6-item credibility/ expectancy questionnaire.

  11. Therapeutic alliance

    Time frame: Immediate post-intervention

    The 12-item Working Alliance Inventory (WAI-SF)will be used to assess agreement on the therapy goal, patients' agreement with the therapist, and quality of the interpersonal bond. Both the participants and therapists will be asked to fill in the WAI-SF immediate post-intervention

  12. Treatment satisfaction

    Time frame: Immediate post-intervention

    Treatment satisfaction will be assessed using the evaluation form. Participants will be asked to indicate their overall satisfaction with the intervention they have received.

Other outcomes

  1. Demographic data

    Time frame: Baseline

    Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire

  2. Clinical data

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

    Clinical data will be extracted from medical records.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Research Grants Council, Hong Kong

Registry information

Official study title

The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 29, 2020
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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