Cancer Survivors' Fear of Cancer Recurrence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taipei University of Nursing and Health Sciences
About this trial
The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses' health education and information for those having a lower level of concern. Those who have medium or higher levels of concerns will be randomized to receive "stepping up" either a "ConquerFear psychological cognitive training" or a "healthy lifestyle - individualized exercise and nutrition guidance".
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
stage I, II, III breast, head and neck, colo-rectal, proste cancer and completion of primary cancer treatment
report of fear of cancer recurrence
able to read and listen in Manderin and without a cognitive defect
Disqualifiers
diagnosed with severe mental illness
difficult to communicate in Manderin
Trial design
Design model
Parallel
Treatments tested in this trial
psycological cognitive training
BehavioralMetacognition
Healthy lifestyle
Behavioralindividualized nutrition and exercise guidance
education
BehavioralFCR education
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: education groupActive comparator 1 intervention
Group B: ConquerFear groupExperimental treatment 2 interventions
Group C: Healthy lifestyle groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Fear of Cance Recurrence
the change of FCR (Fear of Cancer Recurrence) score as measured by FCRI
Time frame
From the baseline to the 3 months after intervention at 5 monthsSecondary outcomes
1
Psychological distress
the change of the anxiety and depression as measured by HADS
Time frame
From the baseline to the 3 months after intervention at 5 months2
QOL
The change of the quality of life score as measured by VR-12
Time frame
From the baseline to the 3 months after intervention at 5 monthsOther outcomes
1
Metacognition
the change of metacognition as measured by MCQ-30
Time frame
From the baseline to the 3 month after intervention at 5 months2
Intervention Satisfaction
the score of self-designed satisfaction score with the intervention
Time frame
at the end of intervention at 2 monthLocations
Sponsors and contacts
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National Taipei University of Nursing and Health Sciences
Lead sponsor
Ministry of Health and Welfare, Taiwan
Collaborator
Koo Foundation Sun Yat-Sen Cancer Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: