Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• newly diagnosed DTC patients

• after received thyroid tumor excision operation (total thyroidectomy)

Locations
Other Locations
Taiwan
Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
RECRUITING
Taipei
Contact Information
Primary
Yeur-Hur Lai
laiyhwk@ntu.edu.tw
886-2-23123456
Time Frame
Start Date: 2018-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 380
Treatments
No_intervention: General module
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.
Experimental: NLSCP
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.
Experimental: ICT supported HAP
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.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov