Compare the Effects of NLSCP and Interactive ICT Supported HAP on Differentiate Diagnosed Thyroid Cancer Patients

National Taiwan University

Status: Enrolling

Conditions: Differentiated Thyroid Cancer

Treatments: Other: NLSCP; Other: ICT supported HAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03757637

201712196RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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380 participants in 3 patient groups

General module

No Intervention group

Description:

Control group will be "case manager care only" group. Eligible patients will also invite and receive their first time assessment as baseline during hospitalization. The usual cancer care group will receive routine cancer care in the inpatient wards through OPD visits.

NLSCP

Experimental group

Description:

NLSCP group will receive 5 section of NLSCP. Contents of scheduled intervention will be developed baed on the literature mentioned above. Ex 1 group, patients will receive at least 3 times face-to-face NLSCP, and two times by telephone calls for following up.

Treatment:

Other: NLSCP

ICT supported HAP

Experimental group

Description:

The ICT supported HAP group will receive information or counseling through mobile phone App as the schedule intervention time. For this group, patients will receive two face to face interventions in the first two sections (pre-discharge from hospital and 5th week post-op). It will be delivered by research nurse to intervene patients and help them to build up the App system. Research nurse will also help patients to be familiar with the operation system. The rest parts of the intervention will all through Apps in the scheduled time. Patients can raise their questions and concerns through APPs. Patients in the HAP can raise their concerns or questions through APP and receive interventions or answers through App interactively.

Treatment:

Other: ICT supported HAP