Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ConquerFear intervention, CALM intervention, Basic Cancer Care.
- Who it may be relevant to
- Registry conditions: Advanced or Metastatic Cancer, Fear of Cancer Progression, Metacognition-based Intervention, Supportive-expressive Based Intervention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral ConquerFear intervention
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). - Behavioral CALM intervention
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 patien - Behavioral Basic Cancer Care
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
Primary outcome measures
- Fear of Progression [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
Secondary outcome measures (3)
- Metacognitions [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
- Depression [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
- Death anxiety [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 4 centers
- Queen Mary Hospital-Department of Obstetrics & Gynaecology — Hong Kong
- Queen Mary Hospital-Department of Oncology — Hong Kong
- Queen Mary Hospital-Department of Surgery — Hong Kong
- Tung Wah Hospital-Department of Surgery — Hong Kong
Identifiers
NCT: NCT05679518 · UW22-036