Background: Despite the good prognosis of patients with differentiated thyroid carcinomas (DTC), the diagnosis of cancer, fear of cancer recurrence and its side effects might still bring impacts on patients' quality of life and daily function. Purposes: This is a two-phase study. Phase I will aim to examine the current concerns of patients' physical-, psychological, care needs, and physical and psychological function in DTC patients within one year of diagnosis, and identify factors related to patients' physical and psychological functions. Phase II will be a three-group randomized control trail (RCT). The aims will be develop two intervention programs: Nurse-led Survivorship Care Program (NLSCP, Exp-1) and Information \& Communication Technology (ICT) Supported Healthy Active Program (ICT supported HAP, Exp-2), and compare the effects of the two intervention groups and control group of their effects on the variables in the above mentioned four dimensions (physical, psychological, care needs, function) in newly diagnosed DTC patients receiving total thyroidectomy. Methods: Phase I is a cross-sectional survey study and to examine the current status of physical distress (e.g., fatigue, pain), psychological distress (e.g., depression, body-image), care needs, and psychological \& physical functions. Phase II is a 6-month three-group RCT with 12 month follow-up of its effects. There will have 5 intervention sections during the first 6 month. Control group will be case manager care only. The NLSCP will receive face-to-face or telephone education by trained nurse. The ICT supported HAP group will receive information or counseling through mobile phone App as the schedule intervention time. For both Exp groups, the first 2 sections of interventions will be all delivered face-to-face for helping them to be familiar with the operation system. Patients in the ICT supported HAP group can raise their concerns or questions through APP and receive intervention through App interactively. The outcomes will be assessed at 5 time points: time before first intervention (baseline assessment), 4-5 week before intervention, 3-, 6-, and 12 months. Expected Outcome: We expect this study can help us better understanding DTC patients' impacts and care needs. The comparison of three groups of intervention will also help us to identify the best model to decrease distress and enhance life function for them.
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Hospital Anxiety & Depression Scale (HADS)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Fear of Recurrence Inventory
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Body Image Scale (BIS)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Fatigue Severity Inventory
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Pittsburgh's Sleep Index
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Brief Supportive Care Needs Survey (SCNS-9)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Short Form 12 (SF-12)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Symptom Severity Scale (SSS)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Impact of Event Scale-Revised (IES-R)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
Illness Perception Questionnaire (IPQ-M)
Timeframe: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).