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

Learn more about:
Related Clinical Trial
The Oral Microbiome in OSCC The Link Between Periodontitis, Smoking and Oral Cancer Research on Optimization and Evaluation of Oral Cancer Screening Methods Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings Topical Aldara (Imiquimod) for Oral Cancer Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions LLL Phototherapy in Oral Lesions Resulting From Anti-neoplastic Treatment Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial Understanding Non-radiotherapy-based Development of Trismus Use of Ultrasound for Measuring Size of Oral Tongue Cancers Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients Oral Cancer Screening and Education in Hong Kong Evaluating Oral Visual Inspection in the Control of Oral Cancer Inductive Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients Effects of EMG Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection: a Randomized Clinical Trial Prevention of Oral DNA Damage by Black Raspberries Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma NBI in Oral Cavity Cancer Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer Physical Activities by Technology Help (PATH) Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients Patient Evaluation for Head and Neck Surgery Branch Studies Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy Prospective Analysis of Robot-Assisted Surgery Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Cigarette Smoking and Oral Microbiota Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line The Role of Lymphangiogenesis in Head and Neck Cancer Metastasis Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis Least Invasive Nonlinear Light Microscopy Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients Improving Access to Control of Diseases for Women IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Submandibular Gland Preservation in Neck Dissection uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression The Use of Functional Confections in Promoting Oral Health The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions Wild Type p53 Adenovirus for Oral Premalignancies Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Trial of IIb Preserving Neck Dissection Expression of Hypoxia-Inducible Factor-α in Oral Precancers and Cancers Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography Innovative Approach to Triage Oral Precancer The Role of SDF-1/CXCR4 in Metastasis of Oral Squamous Cell Carcinoma Rehabilitation Outcomes in Head and Neck Survivors Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions The Relation of Microtubule-Associated Protein 2 and Cell Migration Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study) Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue Oral Pathology Asynchronous Telementoring Pilot Study Polarized Reflectance Spectroscopy for Oral Lesions A Study of the Effects of PEITC on Oral Cells With Mutant p53 Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma The Role of microRNA-29b in the Oral Squamous Cell Carcinoma Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer – COOLS TRIAL Assessment of Mandibular Bone Invasion With MRI Using SWIFT Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients Epstein-Barr Detection in Oral Cancer Workplace Tobacco Cessation And Oral Cancer Screening Study Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer. Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies Effects of Mouth-opening Training on the Maximum Interincisal Opening Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy – 3-years Prospective Study Erlotinib Prevention of Oral Cancer (EPOC) Oral Cancer Screening in Mumbai, India by Primary Health Care Workers Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor. The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer. Validation of DNA Methylation Biomarkers for Oral Cancer Detection Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention Expression of VEGF-C and VEGF-CR in Oral Cancers and Premalignant Lesions PET/CT and Sentinel Node in Oral Cancer Validation of DNA Methylation Biomarkers for Oral Cancer Detection Web-based Education on Oral Cancer for Primary Care Physicians in Ohio Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients Using an APP in Post Oral Cancer Surgery to Affect Patients’ Needs and Quality of Life.

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