Trial Title:
Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches
NCT ID:
NCT05679518
Condition:
Advanced or Metastatic Cancer
Fear of Cancer Progression
Metacognition-based Intervention
Supportive-expressive Based Intervention
Psychooncology
Conditions: Official terms:
Neoplastic Processes
Disease Progression
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
The investigator, care provider, and outcomes assessor are masked in terms of not knowing
to which condition the participants will be randomized until after the completion of the
baseline assessment. The outcomes assessor will break the envelope for the next eligible
participant indicating if that participant is to be allocated to ConquerFear or CALM or
control arms.
The participants are masked in terms of not knowing that the interventions (i.e. Conquer
fear and CALM) are hypothesized to yield larger effects than the other (i.e. control).
Intervention:
Intervention type:
Behavioral
Intervention name:
ConquerFear intervention
Description:
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.
Arm group label:
ConquerFear intervention
Intervention type:
Behavioral
Intervention name:
CALM intervention
Description:
CALM is a semi-structured, manualized, individual psychotherapy intervention designed for
patients with advanced cancer. It includes 3-6 individual therapy sessions, with each
approximately lasts 45-60 minutes, delivered over 3-6 months. The sessions cover 4
domains: 1) symptom management and communication with health care providers; 2) changes
in self and relations with close others; 3) sense of meaning and purpose; and 4) the
future and mortality. All modules will be addressed with each patient, but the sequencing
and time devoted to each domain can be varied, based on the concerns that are most
relevant to each patient.
Arm group label:
CALM intervention
Intervention type:
Behavioral
Intervention name:
Basic Cancer Care
Description:
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.
Arm group label:
Basic Cancer Care
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Karen Chan
Email:
kklchan@hku.hk
Facility:
Name:
Queen Mary Hospital-Department of Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Wendy Chan
Email:
winglok@hku.hk
Facility:
Name:
Queen Mary Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Dominic Foo
Email:
ccfoo@hku.hk
Facility:
Name:
Tung Wah Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Ava Kwong
Email:
avakwong@hku.hk
Start date:
December 20, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Research Grants Council, Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679518
