Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Supportive-expressive Based Intervention; Advanced or Metastatic Cancer; Metacognition-based Intervention; Fear of Cancer Progression; Psychooncology

Treatments: Behavioral: ConquerFear intervention; Behavioral: Basic Cancer Care; Behavioral: CALM intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05679518

UW22-036

Details and patient eligibility

About

The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

Full description

A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

The aims are to test:

1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and
2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Primary hypothesis:

1. Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression.
2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.
3. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Enrollment: 261 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer
• are the age of 18 years or above

Exclusion criteria

• Patients with major communication difficulties
• are being unwilling or unable to commit 6 psychotherapy sessions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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261 participants in 3 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:

Behavioral: ConquerFear intervention

CALM intervention

Experimental group

Description:

Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.

Treatment:

Behavioral: CALM 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:

Behavioral: Basic Cancer Care