Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work

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Brief Title

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

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.

Study Type

Interventional

Primary Outcome

Changes in University of Washington - Quality of Life (UW-QoL)

Condition

Oral Cancer

Intervention

Personalized Survivor Care Plan (PSCP)

Study Arms / Comparison Groups

 General module
Description:  General module will serve as a "roadmap plan" which will cover the most common problems and major issues related to current and future treatments, side effects, psychological distress, daily function and physical condition. The contents will be developed based on empirical review, our current research findings in Taiwan, OC health care experts' suggestions.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Combination Product

Estimated Enrollment

300

Start Date

December 1, 2017

Completion Date

July 31, 2020

Primary Completion Date

July 31, 2020

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Yeur-Hur Lai, Professor, 886-2-23123456, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT04214912

Organization ID

201703103RINC

Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital

Study Sponsor

Yeur-Hur Lai, Professor, Study Chair, School of Nursing, College of Medicine, National Taiwan University

Verification Date

December 2019