Clinical trial NCT04568226: The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence
Official title: The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Cancer Recurrence
Keywords: Fear of cancer recurrence
Metacognition
Cancer survivorship
Psychooncology
Breast cancer
Colorectal cancer
Gynecologic cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2020-09-29
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will use a block randomization structure with randomly permuted block sizes of 2,4, and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias.

We will also use a block randomization structure with randomly permuted block sizes of 4 and 8 to ensure an equal case allocation to each therapist.

We will also use a block randomization structure with randomly permuted block sizes of 2,4, and 6 to ensure an equal case allocation to each dietitian.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

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

Primary hypothesis:

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Fear of cancer recurrence
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Secondary outcomes:
measure: Metacognitions
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months
measure: EORTC QLQ-C30
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Self-efficacy
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Coping behavior
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Experimental avoidance
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Cognitive Attentional Syndrome
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Intolerance of uncertainty
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Psychological distress
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Cancer-related distress
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
measure: Treatment expectancy
timeFrame: Baseline and immediate post-intervention
measure: Therapeutic alliance
timeFrame: Immediate post-intervention
measure: Treatment satisfaction
timeFrame: Immediate post-intervention
Other outcomes:
measure: Demographic data
timeFrame: Baseline
measure: Clinical data
timeFrame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Surgery
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital-Breast Center
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital-Department of Surgery
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Obstetrics & Gynaecology
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong Jockey Club Institute of Cancer Care
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital-Department of Surgery
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Wing Tak Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng DWL, Foo CC, Ng SSM, Kwong A, Suen D, Chan M, Or A, Chun OK, Fielding BFS, Lam WWT. The role of metacognition and its indirect effect through cognitive attentional syndrome on fear of cancer recurrence trajectories: A longitudinal study. Psychooncology. 2020 Feb;29(2):271-279. doi: 10.1002/pon.5234. Epub 2019 Dec 23.
citation: Ng DWL, Kwong A, Suen D, Chan M, Or A, Ng SS, Foo CC, Fielding BFS, Lam WWT. Fear of cancer recurrence among Chinese cancer survivors: Prevalence and associations with metacognition and neuroticism. Psychooncology. 2019 Jun;28(6):1243-1251. doi: 10.1002/pon.5073. Epub 2019 Apr 26.
citation: Butow PN, Turner J, Gilchrist J, Sharpe L, Smith AB, Fardell JE, Tesson S, O'Connell R, Girgis A, Gebski VJ, Asher R, Mihalopoulos C, Bell ML, Zola KG, Beith J, Thewes B. Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. J Clin Oncol. 2017 Dec 20;35(36):4066-4077. doi: 10.1200/JCO.2017.73.1257. Epub 2017 Nov 2.