Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches
NCT05679518 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 261
Last updated 2025-04-03
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.
Conditions
- Advanced or Metastatic Cancer
- Fear of Cancer Progression
- Metacognition-based Intervention
- Supportive-expressive Based Intervention
- Psychooncology
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). 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.
- 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 patient, but the sequencing and time devoted to each domain can be varied, based on the concerns that are most relevant to each patient.
- 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 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.
Sponsors & Collaborators
-
Research Grants Council, Hong Kong
collaborator OTHER -
The University of Hong Kong
lead OTHER
Principal Investigators
-
Wendy Wing Tak Lam, PhD · School of Public Health, The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-20
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-30
Countries
- Hong Kong
Study Locations
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