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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Fear of Cancer Recurrence

Treatments: Other: ConquerFear Intervention; Other: Active control: Basic Cancer Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04568226

UW19-183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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177 participants in 2 patient groups

ConquerFear Intervention

Experimental group

Description:

Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.

Treatment:

Other: ConquerFear Intervention

Basic Cancer Care

Active Comparator group

Description:

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 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.

Treatment:

Other: Active control: Basic Cancer Care