Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05679518
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2022-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nThe 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).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 261}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear of Progression', 'timeFrame': 'Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Metacognitions', 'timeFrame': 'Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention', 'description': 'The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style.'}, {'measure': 'Depression', 'timeFrame': 'Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention', 'description': 'Change in total scores of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, with higher scores indicative of a higher level of depression. The PHQ-9 is a reliable and valid 9-item measure of depression that has been used widely in advanced cancer patients.'}, {'measure': 'Death anxiety', 'timeFrame': 'Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention', 'description': 'Change in total scores of death anxiety will be assessed by the 15-item Death and Dying Distress Scale (DDDS). The DDS score can range from 0 to 90, with higher scores indicative of a higher level of death anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Cancer', 'Fear of Cancer Progression', 'Metacognition-based Intervention', 'Supportive-expressive Based Intervention', 'Psychooncology']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe aims are to test:\n\n1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and\n2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.\n\nPrimary hypothesis:\n\n1. 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.\n2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.\n3. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer\n* are the age of 18 years or above\n\nExclusion Criteria:\n\n* Patients with major communication difficulties\n* are being unwilling or unable to commit 6 psychotherapy sessions'}, 'identificationModule': {'nctId': 'NCT05679518', 'briefTitle': 'Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UW22-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ConquerFear intervention', 'description': 'Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.', 'interventionNames': ['Behavioral: ConquerFear intervention']}, {'type': 'EXPERIMENTAL', 'label': 'CALM intervention', 'description': 'Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.', 'interventionNames': ['Behavioral: CALM intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Basic Cancer Care', 'description': "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.", 'interventionNames': ['Behavioral: Basic Cancer Care']}], 'interventions': [{'name': 'ConquerFear intervention', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['ConquerFear intervention']}, {'name': 'CALM intervention', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['CALM intervention']}, {'name': 'Basic Cancer Care', 'type': 'BEHAVIORAL', '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.", 'armGroupLabels': ['Basic Cancer Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Karen Chan', 'role': 'CONTACT', 'email': 'kklchan@hku.hk'}], 'facility': 'Queen Mary Hospital-Department of Obstetrics & Gynaecology', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'NOT_YET_RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Wendy Chan', 'role': 'CONTACT', 'email': 'winglok@hku.hk'}], 'facility': 'Queen Mary Hospital-Department of Oncology', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Dominic Foo', 'role': 'CONTACT', 'email': 'ccfoo@hku.hk'}], 'facility': 'Queen Mary Hospital-Department of Surgery', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'NOT_YET_RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Ava Kwong', 'role': 'CONTACT', 'email': 'avakwong@hku.hk'}], 'facility': 'Tung Wah Hospital-Department of Surgery', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Danielle Wing Lam Ng, PhD', 'role': 'CONTACT', 'email': 'dwlng@hku.hk', 'phone': '+852 39179897'}], 'overallOfficials': [{'name': 'Wendy Wing Tak Lam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Public Health, The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication will be available from the PI upon reasonable request.', 'accessCriteria': 'Information will be available from the PI upon reasonable request. The author to review requests is the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Grants Council, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wendy Wing Tak Lam', 'investigatorAffiliation': 'The University of Hong Kong'}}}}