Clinical trial NCT05679518: Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches
Official title: Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced or Metastatic Cancer
Fear of Cancer Progression
Metacognition-based Intervention
Supportive-expressive Based Intervention
Psychooncology
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2023-01-11
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use a block randomization structure with randomly permuted block sizes of 3 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fear of Progression
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Secondary outcomes:
measure: Metacognitions
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
measure: Depression
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
measure: Death anxiety
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Obstetrics & Gynaecology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Surgery
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: