Clinical trial NCT04214912: Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work
Official title: Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Cancer
Keywords: Oral Cancer
Intervention
Return to work
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 300
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 OC 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. PSCP-OC will include two major modules: General \& Personalized Modules.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Due to the complex treatment modalities and long-term side effects, oral cancer (OC) patients might suffer from psychological and physical distress and be unable to return to work (RTW).

Purposes: This is a two-phase study. First, the investigator aims to validate a scale about OC patients' perception of RTW and identify those concerns in RTW. Second, the investigator aims to (1) develop the contents of a "Personalized Survivorship Care Plan- Oral Cavity Cancer (PSCP-OC)" and (2) examine the short and long-term effects of PSCP-OC on patients' physical function (symptoms, muscle strengths, fitness, nutrition status), psychological distress (depression, fear of cancer recurrence) and RTW.

Method: First phase, the investigator will modify and validate the "Illness Perception Questionnaire (IPQ)" with adding the head and neck cancer specific items (modified IPQ-mHN) to assess the barriers of RTW in OC patients. The investigator will recruit 300 subjects in this phase to test the IPQ-mHN psychometrics. The second and third year will develop and test the PSCP-OC intervention. Eligible subjects will be (1) newly diagnosed OC patients with surgery, and (2) who are at work in time of diagnosis. A stratified randomization by cancer stage would be conducted. Both groups will receive baseline assessment before first intervention. PSCP-OC is a 6-month intervention which includes two parts: General module and Personalized module (150 subjects for each group). Ex group will receive the first PSCP-OC before discharge and 3 times face-to-face PSCP-OP once a month in the first three month after discharge and 3 times telephone physical-psycho-education interventions in month 4-6. Control group will receive regular and cancer case manager cares for 6 months. Each group will be followed for 12 months and assess of their outcomes at 6 time points: baseline (pre-discharge) and 1, 3, 6, and 12 months after surgery. Outcomes will be evaluated by physical distress, muscle strength, nutrition status, and length of time of RTW since completion of last major treatment. Results would be analyzed mainly by GEE. IRB approval will be received before the RCT.

Expected Outcome: Expecting to develop a scale to identify those barriers preventing OC patients' RTW and further to test the PSCP. A promising result will further apply into clinical care to prevent or decrease the potential declined physical and psychological functions, increase their strength and help them RTW.

Detailed description: Supportive Care has been proved to not only increase patients' life quality but also their survival time. An influential randomized control study published on the New England Journal of Medicine (Temel et al., 2010) found that the early palliative (supportive) care could significantly improve patients' QOL and median survival time (11.6 month vs. 8.9 months) in a 151 metastatic NSCLC patients. This study strongly supports our clinical care needs and scientific assumption that effective and continuous supportive care is needed in advanced OC patients.

However, in Taiwan, there is no insurance paying for supportive care in both inpatient and particularly in OPD (only pay for treatment and physician fee). In order to meet patients' care need and concerning the reality of our medical payment system, the investigator aims to develop a systematic well-planed and efficient survivor care plan (SCP), with taking consideration of OC patients/survivors' personal care needs across different cancer process.

Survivorship Care Plan (SCP) Cancer survivor is defined as "any patient who has been diagnosed with cancer and continues through their lifespan(NIH, 2014)". One of the most important reports about survivorship care and content of care has been reported by Institute of Medicine (IOM, 2006). According to IOM, the essential component of survivorship care includes "communication and coordination of care, prevention and detection of recurrence, assessment and management of treatment/disease related distress or late effects. A well-designed survivor care plan (SCP) has been viewed as an important communication tool to improve transitions of care for cancer patients. Increasing attentions and reports have been found about the values of SCP from Office of Cancer Survivorship, and American Society of Clinical oncology (Mayer, 2014) and strongly suggest to use SCP in clinical cancer practice to increase the care quality and long-term cancer survivors' quality of life.

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, the investigator takes a large number of advanced OC 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.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed operable oral cavity cancer patients with at least neck dissection
* patients has work at time of diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in University of Washington - Quality of Life (UW-QoL)
timeFrame: We will assess patients' the changes of 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: Changes in Hospital Anxiety & Depression Scale (HADS)
timeFrame: We will assess patients' the changes of 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: Changes in Illness Perception Questionnaire (IPQ) - the head and neck cancer specific items (modified IPQ-mHN)
timeFrame: We will assess patients' the changes of 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: Changes in Fear of Recurrence Questionnaire (FoR)
timeFrame: 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: Changes in Exercise and Muscle Power
timeFrame: We will assess patients' the changes of 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: Changes in Brief Supportive Care Needs Survey (SCNS-ST9)
timeFrame: We will assess patients' the changes of 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: Otorhinolaryngology Department, National Taiwan University Hospital
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
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