Clinical trial NCT03757637: Compare the Effects of NLSCP and Interactive ICT Supported HAP on Differentiate Diagnosed Thyroid Cancer Patients
Official title: Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Differentiated Thyroid Cancer
Keywords: Thyroid cancer
Survivorship Care
Mobile applications
Mobile phone
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are various models of SCP, in general, the primary care physician model or nurse-led model are generally being recognized for effective detecting patients' distress and recurrences, effective coordination and communication, and taking SCP as standard cancer care. In Taiwan, we take a large number of advanced DTC patients, it is important to integrate the SCP but also need to concern about the limited time in busy OPD clinics and patients' differences because of various physical or psychological conditions and needs. We will build up the contents and operable programs for two interventions groups: NLSCP and ICT supported HAP.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Phase I is a cross-sectional survey study (first year) with the specific aims to examine the current status of physical distress (fatigue, sleep dysfunction, other symptoms), psychological distress (fear of cancer recurrence, depression, body-image), care needs, and psychological \& physical functions in DTC patients diagnosed within three years. We will also examine these factors of their relationship with physical and psychological function by short-form -12.

Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. Eligible subjects will be those newly diagnosed DTC patients with total thyroidectomy. A stratified randomization by age (age 45 as cut-off point) and gender would be conducted. Although the different intervention designs in the two intervention groups (NLSCP \& ICT supported HAP). The three groups, control and two intervention groups (Exp-1 \& Exp-2) will all receive the hospital routine and case manager's care. The three groups will receive baseline assessment before first intervention during hospitalization. We will first build up the contents and operable programs for two interventions groups: nurse-led survivorship care program (NLSCP/ Exp-1) and ICT supported HAP (ICT supported HAP/ Exp-2). Both intervention groups will also receive routine case manager care too. For both intervention groups, there will have 5 intervention sections during the first 6 month, including one day before hospital discharge post-operation, 5-6th week and 2-, 3-, 5- month post operation, known as intervention 1-5, respectively.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed DTC patients
* after received thyroid tumor excision operation (total thyroidectomy)

Exclusion Criteria:

* primary unknown
* conscious unclear
* recurrence or with bone meta

Primary outcomes:
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
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