Oral CancerNCT04214912
Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work
A study testing Personalized Survivor Care Plan (PSCP) in people with Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Personalized Survivor Care Plan (PSCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- newly diagnosed operable oral cavity cancer patients with at least neck dissection
- patients has work at time of diagnosis
Who cannot join
- primary unknown
- conscious unclear
- recurrence or with bone meta
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Otorhinolaryngology Department, National Taiwan University Hospital
Taipei, 100
Yeur-Hur Lai, laiyhwk@ntu.edu.tw
Yeur-Hur Lai
About this study
Official title: Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
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.
Read more
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.
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- Personalized Survivor Care Plan (PSCP)
- Keywords
- Oral Cancer, Intervention, Return to work
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Survivor Care Plan (PSCP)Combination product
Based the above literature review and our previous 10 years' efforts in OC patients' distress and care needs survey, we categorize OC patients' distress and needs into 6 major dimensions (1) symptoms management and dysfunction prevention (different kind of symptom, such as swallowing difficulty, eating difficulty, speaking difficulty, difficulty in opening mouth/trismus, shoulder dysfunction, mucositis, pain, fatigue, etc), (2) enhancing physical function (exercise skills, types for major parts of muscle training), (3) Confronting and dealing with psychological distress (fear, anxiety, depression, uncertainty), (4) nutrition assessment and counseling, (5) Social connection and RTW counseling (attitudes and skills for returning to work), and (6) overall needs assessment and supports.
| Study group | Role | What they receive |
|---|---|---|
| General module | No intervention | 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. |
| Personalized module | Experimental | Personalized Survivor Care Plan (PSCP) will deliver based on what we assess or interview about patients' distress, concerns and care needs in each interview or/and assessment. We will assess OC patients of the above items by valid assessment tools. For the factors or concerns about RTW assessment, we will develop and test a modified instrument for the study purpose. For each assessment, the computer -assisted assessment will help the OC educator to immediately catch the patients care distress and care needs. It will provide the direction for caring of their personalized distress, concerns and needs. Receives: Combination Product: Personalized Survivor Care Plan (PSCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in University of Washington - Quality of Life (UW-QoL)
It is characterized of its simplicity and developed to quickly assess head and neck cancer patients' health related QOL. Four versions have been developed since 1993 (Hassan \& Wymuller, 1993; Weymuller, Alsarraf, Yueh, Deleyiannis, \& Coltrera, 2001). The current version, UW-QOL version 4 contains 12 items that to assess 12 domains of QOL in head and neck cancer patients, and each domain is scored from 0-100 with the higher scores indicating better function (Roger et al., 2002). It has been translated into Chinese and tested for its psychometrics in our previous head and neck cancer populations in Taiwan (Lee et. al., 2018).
Measured: 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)
Changes in Hospital Anxiety & Depression Scale (HADS)
The severity of cancer patients' anxiety and depression will be measured by the self-reported HADS. The 14 items of HADS consists of two subscales, include 7 items anxiety and 7 items depression. The score of all items ranges from 0 (not at all) to 3 (always) and the total score of each subscale are ranged from 0 to 21 with a higher score indicating a higher level of anxiety or depression. Satisfactory psychometrics of the HADS has been shown in cancer populations in Taiwan (Chen et al., 2000).
Measured: 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)
Changes in Illness Perception Questionnaire (IPQ) - the head and neck cancer specific items (modified IPQ-mHN)
The questionnaire was originally developed from Broadbent, Petrie, Main and Weinman (2006) to measure patients' perception about their illness and it has proved to have good psychometric characteristics. The IPQ was further modified by Grunfeld. Low, and Cooper (2010) to assess cancer patients' perception about the impacts of cancer and its treatments on their work. Concerning about part of the purposes of this study is to examine OC patients' concerns, perception and barriers of their RTW and further use it to a wider range of HNC patients, we will therefore add head and neck cancer specific items to become IPQ-mHN to fit into different types of HNC and also OC patients. The 26 item IPQ-M was a 7-point Likert's scale with 0 to 7 scoring and the higher the sum scores (0-119) indicates more concerns or barriers about RTW.
Measured: 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)
Changes in Fear of Recurrence Questionnaire (FoR)
The FoR-C is a Chinese version of the original FoR questionnaire. The FoR questionnaire consists of six statements with a five-point response scale from not at all (1), a little, sometimes (2), a lot , and all the time) and one statement with a response scale from 0 (not at all) to 10 (a great deal). The summary of FoR ranges from 6 to 40. Higher score indicates a higher level of fear of recurrence. The significance of the FoR was indicated by patients' responses 'a lot' or 'all the time' for the first six statements and the score of 7-10 for the last item, in which case. Current study will use the same approach to determine the cut-off point of the FoR.
Measured: 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)
Changes in Exercise and Muscle Power
This measures has been applied in PI's currently head and neck study and early stage lung cancer follow up study. Muscle strength and endurance we will use grip strength meter to measure the strength of right and left upper limbs; and will use microFET 2 to measure the strength of right and left hip flexor muscle. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies (Schaubert \& Bohannon, 2005). First, patients will be asked to stand up, put arms by sides, and hold the meter to make a fist with maximal force for two times to record upper limbs strength. Secondly, patients will be seated on the chair. The researcher will put the microFET 2 on the upper edge of knee, and then let patient maintain the thigh raise for four seconds to record the strength of right and left hip flexor muscle.
Measured: 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)
Changes in Brief Supportive Care Needs Survey (SCNS-ST9)
The unmet needs of lung cancer patient will be measured by 9 items SCNS. It consists of 5 domains, include psychological, health system and information, daily living, patient care and sexuality domain. Response options "No need, not applicable (1); No need, satisfied (2); Low need (3); Moderate need (4); High need (5). The sum of item scores within each domain will be calculated and transformed to a standardized score from 0 to 100, with higher scores indicating more unmet needs (Girgis et al, 2011). The Chinese SCNS34 has acceptable psychometric properties in previous lung cancer studies (Liao et al., 2011; Shun et al., 2014).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Dec 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeur-Hur Lai, Professor, Study chair, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214912
- Sponsor's protocol ID
- 201703103RINC
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PubMed 20818875Hassan SJ, Weymuller EA Jr. Assessment of quality of life in head and neck cancer patients. Head Neck. 1993 Nov-Dec;15(6):485-96. doi: 10.1002/hed.2880150603.
PubMed 8253555Weymuller EA Jr, Alsarraf R, Yueh B, Deleyiannis FW, Coltrera MD. Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Arch Otolaryngol Head Neck Surg. 2001 May;127(5):489-93. doi: 10.1001/archotol.127.5.489.
PubMed 11346422Rogers SN, Lowe D, Fisher SE, Brown JS, Vaughan ED. Health-related quality of life and clinical function after primary surgery for oral cancer. Br J Oral Maxillofac Surg. 2002 Feb;40(1):11-8. doi: 10.1054/bjom.2001.0706.
PubMed 11883963Lee YH, Lai YH, Yueh B, Chu PY, Chen YJ, Chen SC, Wang CP. Validation of the University of Washington Quality of Life Chinese Version (UWQOL-C) for head and neck cancer patients in Taiwan. J Formos Med Assoc. 2017 Apr;116(4):249-256. doi: 10.1016/j.jfma.2017.01.002. Epub 2017 Feb 15.
PubMed 28214178Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Chen ML, Chang HK, Yeh CH. Anxiety and depression in Taiwanese cancer patients with and without pain. J Adv Nurs. 2000 Oct;32(4):944-51.
PubMed 11095234Grunfeld EA, Low E, Cooper AF. Cancer survivors' and employers' perceptions of working following cancer treatment. Occup Med (Lond). 2010 Dec;60(8):611-7. doi: 10.1093/occmed/kqq143. Epub 2010 Sep 20.
PubMed 20855546Schaubert KL, Bohannon RW. Reliability and validity of three strength measures obtained from community-dwelling elderly persons. J Strength Cond Res. 2005 Aug;19(3):717-20. doi: 10.1519/R-15954.1.
PubMed 16095431Girgis A, Lambert S, Lecathelinais C. The supportive care needs survey for partners and caregivers of cancer survivors: development and psychometric evaluation. Psychooncology. 2011 Apr;20(4):387-93. doi: 10.1002/pon.1740. Epub 2010 Apr 5.
PubMed 20878835McElduff, P., Boyes, A., Zucca, A., & Girgis, A. (2004). Supportive Care Needs Survey: A guide to administration, scoring and analysis. Newcastle: Centre for Health Research & Psycho-oncology.
Liao YC, Liao WY, Shun SC, Yu CJ, Yang PC, Lai YH. Symptoms, psychological distress, and supportive care needs in lung cancer patients. Support Care Cancer. 2011 Nov;19(11):1743-51. doi: 10.1007/s00520-010-1014-7. Epub 2010 Oct 15.
PubMed 20949362Shun SC, Yeh KH, Liang JT, Huang J, Chen SC, Lin BR, Lee PH, Lai YH. Unmet supportive care needs of patients with colorectal cancer: significant differences by type D personality. Oncol Nurs Forum. 2014 Jan 1;41(1):E3-11. doi: 10.1188/14.ONF.E3-E11.
PubMed 24368251National Institutes of Health (NIH). About cancer survivorship. Available at: http://cancercontrol.cancer.gov/ocs/about/mission.html. Accessed May 30, 2014.
Institute of Medicion (IOM). from cancer patient to cancer survivor-lost in transition. Washington, DC: The National Academies Press; 2006. Report no:0-309-09595-6. Available at: http:// www.iom.edu/reports/2005/from-cancer-patient-to-cancer-survivor-lost-in-transition.aspx.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
- ClinicalTrials.gov ID
- NCT04214912
- Acronym / sponsor ID
- 201703103RINC
- Conditions
- Oral Cancer
- Keywords
- Oral Cancer, Intervention, Return to work
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| General module | No intervention | –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. |
| Personalized module | Experimental | Combination Product: Personalized Survivor Care Plan (PSCP)Personalized Survivor Care Plan (PSCP) will deliver based on what we assess or interview about patients' distress, concerns and care needs in each interview or/and assessment. We will assess OC patients of the above items by valid assessment tools. For the factors or concerns about RTW assessment, we will develop and test a modified instrument for the study purpose. For each assessment, the computer -assisted assessment will help the OC educator to immediately catch the patients care distress and care needs. It will provide the direction for caring of their personalized distress, concerns and needs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosed operable oral cavity cancer patients with at least neck dissection
- patients has work at time of diagnosis
Key exclusion criteria (3 listed)
- primary unknown
- conscious unclear
- recurrence or with bone meta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Survivor Care Plan (PSCP)Based the above literature review and our previous 10 years' efforts in OC patients' distress and care needs survey, we categorize OC patients' distress and needs into 6 major dimensions (1) symptoms management and dysfunction prevention (different kind of symptom, such as swallowing difficulty, eating difficulty, speaking difficulty, difficulty in opening mouth/trismus, shoulder dysfunction, mucositis, pain, fatigue, etc), (2) enhancing physical function (exercise skills, types for major parts of muscle training), (3) Confronting and dealing with psychological distress (fear, anxiety, depression, uncertainty), (4) nutrition assessment and counseling, (5) Social connection and RTW counseling (attitudes and skills for returning to work), and (6) overall needs assessment and supports. | Combination product | Personalized module |
Primary outcome
Changes in University of Washington - Quality of Life (UW-QoL)
Time frame: 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)
It is characterized of its simplicity and developed to quickly assess head and neck cancer patients' health related QOL. Four versions have been developed since 1993 (Hassan \& Wymuller, 1993; Weymuller, Alsarraf, Yueh, Deleyiannis, \& Coltrera, 2001). The current version, UW-QOL version 4 contains 12 items that to assess 12 domains of QOL in head and neck cancer patients, and each domain is scored from 0-100 with the higher scores indicating better function (Roger et al., 2002). It has been translated into Chinese and tested for its psychometrics in our previous head and neck cancer populations in Taiwan (Lee et. al., 2018).
Changes in Hospital Anxiety & Depression Scale (HADS)
Time frame: 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)
The severity of cancer patients' anxiety and depression will be measured by the self-reported HADS. The 14 items of HADS consists of two subscales, include 7 items anxiety and 7 items depression. The score of all items ranges from 0 (not at all) to 3 (always) and the total score of each subscale are ranged from 0 to 21 with a higher score indicating a higher level of anxiety or depression. Satisfactory psychometrics of the HADS has been shown in cancer populations in Taiwan (Chen et al., 2000).
Changes in Illness Perception Questionnaire (IPQ) - the head and neck cancer specific items (modified IPQ-mHN)
Time frame: 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)
The questionnaire was originally developed from Broadbent, Petrie, Main and Weinman (2006) to measure patients' perception about their illness and it has proved to have good psychometric characteristics. The IPQ was further modified by Grunfeld. Low, and Cooper (2010) to assess cancer patients' perception about the impacts of cancer and its treatments on their work. Concerning about part of the purposes of this study is to examine OC patients' concerns, perception and barriers of their RTW and further use it to a wider range of HNC patients, we will therefore add head and neck cancer specific items to become IPQ-mHN to fit into different types of HNC and also OC patients. The 26 item IPQ-M was a 7-point Likert's scale with 0 to 7 scoring and the higher the sum scores (0-119) indicates more concerns or barriers about RTW.
Changes in Fear of Recurrence Questionnaire (FoR)
Time frame: 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)
The FoR-C is a Chinese version of the original FoR questionnaire. The FoR questionnaire consists of six statements with a five-point response scale from not at all (1), a little, sometimes (2), a lot , and all the time) and one statement with a response scale from 0 (not at all) to 10 (a great deal). The summary of FoR ranges from 6 to 40. Higher score indicates a higher level of fear of recurrence. The significance of the FoR was indicated by patients' responses 'a lot' or 'all the time' for the first six statements and the score of 7-10 for the last item, in which case. Current study will use the same approach to determine the cut-off point of the FoR.
Changes in Exercise and Muscle Power
Time frame: 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)
This measures has been applied in PI's currently head and neck study and early stage lung cancer follow up study. Muscle strength and endurance we will use grip strength meter to measure the strength of right and left upper limbs; and will use microFET 2 to measure the strength of right and left hip flexor muscle. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies (Schaubert \& Bohannon, 2005). First, patients will be asked to stand up, put arms by sides, and hold the meter to make a fist with maximal force for two times to record upper limbs strength. Secondly, patients will be seated on the chair. The researcher will put the microFET 2 on the upper edge of knee, and then let patient maintain the thigh raise for four seconds to record the strength of right and left hip flexor muscle.
Changes in Brief Supportive Care Needs Survey (SCNS-ST9)
Time frame: 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)
The unmet needs of lung cancer patient will be measured by 9 items SCNS. It consists of 5 domains, include psychological, health system and information, daily living, patient care and sexuality domain. Response options "No need, not applicable (1); No need, satisfied (2); Low need (3); Moderate need (4); High need (5). The sum of item scores within each domain will be calculated and transformed to a standardized score from 0 to 100, with higher scores indicating more unmet needs (Girgis et al, 2011). The Chinese SCNS34 has acceptable psychometric properties in previous lung cancer studies (Liao et al., 2011; Shun et al., 2014).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Background: PubMed 20818875Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Background: PubMed 8253555Hassan SJ, Weymuller EA Jr. Assessment of quality of life in head and neck cancer patients. Head Neck. 1993 Nov-Dec;15(6):485-96. doi: 10.1002/hed.2880150603.
- Background: PubMed 11346422Weymuller EA Jr, Alsarraf R, Yueh B, Deleyiannis FW, Coltrera MD. Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Arch Otolaryngol Head Neck Surg. 2001 May;127(5):489-93. doi: 10.1001/archotol.127.5.489.
- Background: PubMed 11883963Rogers SN, Lowe D, Fisher SE, Brown JS, Vaughan ED. Health-related quality of life and clinical function after primary surgery for oral cancer. Br J Oral Maxillofac Surg. 2002 Feb;40(1):11-8. doi: 10.1054/bjom.2001.0706.
- Background: PubMed 28214178Lee YH, Lai YH, Yueh B, Chu PY, Chen YJ, Chen SC, Wang CP. Validation of the University of Washington Quality of Life Chinese Version (UWQOL-C) for head and neck cancer patients in Taiwan. J Formos Med Assoc. 2017 Apr;116(4):249-256. doi: 10.1016/j.jfma.2017.01.002. Epub 2017 Feb 15.
- Background: PubMed 16731240Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Background: PubMed 11095234Chen ML, Chang HK, Yeh CH. Anxiety and depression in Taiwanese cancer patients with and without pain. J Adv Nurs. 2000 Oct;32(4):944-51.
- Background: PubMed 20855546Grunfeld EA, Low E, Cooper AF. Cancer survivors' and employers' perceptions of working following cancer treatment. Occup Med (Lond). 2010 Dec;60(8):611-7. doi: 10.1093/occmed/kqq143. Epub 2010 Sep 20.
- Background: PubMed 16095431Schaubert KL, Bohannon RW. Reliability and validity of three strength measures obtained from community-dwelling elderly persons. J Strength Cond Res. 2005 Aug;19(3):717-20. doi: 10.1519/R-15954.1.
- Background: PubMed 20878835Girgis A, Lambert S, Lecathelinais C. The supportive care needs survey for partners and caregivers of cancer survivors: development and psychometric evaluation. Psychooncology. 2011 Apr;20(4):387-93. doi: 10.1002/pon.1740. Epub 2010 Apr 5.
- BackgroundMcElduff, P., Boyes, A., Zucca, A., & Girgis, A. (2004). Supportive Care Needs Survey: A guide to administration, scoring and analysis. Newcastle: Centre for Health Research & Psycho-oncology.
- Background: PubMed 20949362Liao YC, Liao WY, Shun SC, Yu CJ, Yang PC, Lai YH. Symptoms, psychological distress, and supportive care needs in lung cancer patients. Support Care Cancer. 2011 Nov;19(11):1743-51. doi: 10.1007/s00520-010-1014-7. Epub 2010 Oct 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeur-Hur Lai, Professor study chair
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Survivor Care Plan (PSCP) in people with Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeur-Hur Lai, Professor (886-2-23123456 ext. 88429, laiyhwk@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in University of Washington - Quality of Life (UW-QoL) (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214912, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.