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

NCT05679518 | Recruiting

• 1 other identifier: UW22-036
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fear of Progression

  The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Secondary Outcomes (3)

• Metacognitions

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

• Depression

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

• Death anxiety

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Study Arms (3)

ConquerFear intervention

EXPERIMENTAL

Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.

Behavioral: ConquerFear intervention

CALM intervention

EXPERIMENTAL

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

Behavioral: CALM intervention

Basic Cancer Care

ACTIVE COMPARATOR

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.

Behavioral: Basic Cancer Care

Interventions

ConquerFear intervention BEHAVIORAL

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.

ConquerFear intervention

CALM intervention BEHAVIORAL

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.

CALM intervention

Basic Cancer Care BEHAVIORAL

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.

Basic Cancer Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Research Grants Council, Hong Kong: collaborator

Study Sites (4)

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital-Department of Oncology

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong

RECRUITING

Tung Wah Hospital-Department of Surgery

Hong Kong, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy Wing Tak Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Wing Lam Ng, PhD

CONTACT

+852 39179897; dwlng@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 11, 2023
• Study Start: December 20, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (4)