Head and Neck Squamous Cell CarcinomaNCT05267353
Develop and Test the 'Multi-Faced Continuous Exercise Program' in Operable Head and Neck Cancer Patients
A study testing Exercise intervention program in people with Head and Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital.
Trial summary
Background: Due to the disease location and related treatments in head and neck areas following with concurrent chemoradiation therapy (CCRT), patients might suffer a series of acute distress and limit their physical activities. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Exercise intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2013to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects were adult patients (≥20 years old) with newly diagnosed squamous cell type of HNC patients who received tumor excision and neck dissection (either MRND or SND) within 3-4 weeks
- Part of subjects might with postoperative RT or CCRT
Who cannot join
- Patients unable to communicate
About this study
Official title: School of Nursing, College of Medicine, National Taiwan University
Background: Due to the disease location and related treatments in head and neck areas following with concurrent chemoradiation therapy (CCRT), patients might suffer a series of acute distress and limit their physical activities. Limited physical activities might further cause dysfunction in both the upper body and general physical function.
Purposes: This 3-year project will be conducted for three folds, with the purposes to (1) longitudinally examine the upper body function (mouth open abilities/trismus, neck stiffness/flexibility, shoulder function, myofascial pain, and upper arm muscle strengths) and general physical fitness; and (2) develop a 20-week continuous exercise program and test of its effects on improving upper body function, general physical function, fatigue, and quality of life in operable HNC in the first year of being diagnosed as cancer.
Read more
Method: The eligible subjects will be newly diagnosed operable HNC patients. For research purpose (1) (Phase 1), we will conduct the data collection for continuous and follow patients for 12 months (Pre-operation, post-op 1, 3, 6, 12 months,/ T1-T5, respectively) for fatigue, upper body function and general physical fitness, and quality of life. A total of 130 subjects are planned to be recruited based on the sample size calculation. For research purpose (2) (Phase 2), from the second year, the 20-week "Multi-Faced Continuous Exercise Program" will be developed and tested in newly diagnosed operable HNC patients, while compare to those standard care control group of their differences in preventing physical dysfunction and increasing physical function for a 20-week period on post-op 1, 3, \& 6 months (T0-T2, respectively). Data will be analyzed by both descriptive analysis and the Generalized Estimating Equation (GEE). There will be 130 subjects in each group (N=260 total) based on power analysis principles.
Expected Outcome: The results will increase our knowledge about the changes in physical activities, physical function, and dysfunction; and the levels of the effectiveness of a continuous exercise program on increasing head and neck cancer patients' physical function and quality of life.
Read the detailed description
Head and neck squamous cell carcinoma (HNCSCC) is one of the most common cancers in Taiwan. The incidence is rapidly rising and is becoming the leading cause of death in men aged from 40-60 years in recent years. A multimodal treatment approach has led to a relatively good five-year survival rate in HNC patients ranging from 40% to over 50%. A review showed that over the past 10 years, the 5-year survival rate for HNC has increased from 55% to 66%. In other words, with the increasing number of head and neck cancer patients in Taiwan, a rapidly increasing number of survivors and the survival issues related to head and neck cancers are critically necessary to care.
Except those in severe metastasis or terminal condition and those in stage I, the majority of head and neck cancers patients receive a series of treatments, including tumor resection, neck dissection (ND), even reconstruction with free-flap surgery, and CCRT. Due to the disease location and surgery in head and neck areas, many head and neck cancer patients suffer problems in the upper body, particularly head, neck, and shoulder areas. Pain in these areas may cause diminishing function in the upper extremities and weaken the muscle power in the upper extremities.
After the acute distress, patients may also face some long-term problems if those acute problems are not well cared, such as myofascial pain in neck and shoulder areas, trismus from local radiation, and tightness of shoulder. Fatigue and generally declined physical function may also be found to be fatigue, decreasing of physical function, and general malaise. Thus, these declining functions, including both upper extremities and a general weakening in physical function, may further influence patients' physical activities, daily life, and even employment status. It would be therefore very important to systematically assess and intervene in these problems to decrease patients' dysfunction and increase their physical function and quality of life.
Unfortunately, those disease or treatment-related functional declines and decreasing physical activities due to treatments or limited physical conditions may not receive sufficient attention from both health care professionals and patients. Clinically, the major focus has been on treating the life-threatening head and neck cancer, the disease itself. For example, a study was done in UK found that only 8.5% of head and neck cancer survivors reported doing sufficient physical activities which met the current suggested exercise guideline. Very few HNC patients participated in moderate-intensity to vigorous-intensity physical activity. While HNC patients in Taiwan received exercise recommendations before RT, only 16.7% followed WHO exercise recommendations and 14% continued stretching after RT.
Concerning the increasing numbers of head and neck cancer patients and survivors, and the gradually developed physical dysfunction, it would be very important to longitudinally examine the changes of those problems (upper body and general physical function and status of applying physical activities, preferences, and barriers of applying physical activities) during the cancer process. The data would be helpful to develop an evidence-based, brief, easily carried out and comprehensive exercise program that may cover the exercise needs across the cancer process, particularly for the first 6 months of diagnosis (acute treatment phase to off treatment survival phase).
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Exercise intervention program
- Keywords
- head and neck cancer, neck dissection, exercise intervention, quality of life, physical function
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise intervention programBehavioural
It was developed, along with usual care, to prevent restricted ROM in both upper body and limited general physical functioning. Patients in exercise intervention group received verbal instructions about stretching major muscles and phsical activity recommendations from a trained nurse (intervenor), and then received the booklet plus DVD.
The physical therapist who developed and adjusted this program also trained the intervenor. After verifying the intervenor has performed exercise interventions were consistent with the physical therapist, he/she was responsible for all interventions. Therefore, if pain or discomfort persists for more than an hour, the patient should inform the intervenor. The intervention group patients also received telephone follow-up from the intervenor every two weeks until the end of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | All patients received care as usual. Patients receive wound care and pain management post-surgery. Before RT, generally advising to do neck stretch and mouth opening exercises. Telephone follow-up was not provided to usual care group. Furthermore, patients in usual care group went to receive physical therapy were free to do. During the follow-up period, well-trained research nurses (assessors) recorded their physical therapy sections. |
| Exercise intervention programs | Experimental | Based on our previous literature review, we will have two major parts of exercises in our intervention: (1) Upper Body Exercise (stretching in shoulder and neck, and mouth-opening); and (2) General Physical Function Training. Receives: Behavioral: Exercise intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
The 13-item SPADI is composed of two subscales which include pain (5 items), and disability (8 items). The scale is a visual analogue scale, ranging from 0-10 cm, with 0 representing "no difficulty (left anchor)" and 10 representing "so difficult required help (right anchor)". The SPADI total score ranges from 0 to 100 and is obtained by averaging the pain and disability subscale scores. Higher scores indicate greater pain and greater disability. The psychometric testing in a previous study has been reported. The Taiwanese version psychometric testing and scoring in a previous study has been reported.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
University of Washington- Quality of Life (UW-QOL)
University of Washington - Quality of Life (UW-QOL) was characterized of its simplicity and developed to quickly assess head and neck cancer patients' health related QOL. Four versions have been developed since 1993. The current version, UW-QOL version 4 contains 12 items that to assess 12 domains of QOL in head and neck cancer patients. It has been translated into Chinese and tested for its psychometrics in head and neck cancer populations in Taiwan and the 13-item Chinese version (including employment status) of the UWQOL has provided a good reliability and validity.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
University of Washington- Quality of Life (UW-QOL)
University of Washington - Quality of Life (UW-QOL) was characterized of its simplicity and developed to quickly assess head and neck cancer patients' health related QOL. Four versions have been developed since 1993. The current version, UW-QOL version 4 contains 12 items that to assess 12 domains of QOL in head and neck cancer patients. It has been translated into Chinese and tested for its psychometrics in head and neck cancer populations in Taiwan and the 13-item Chinese version (including employment status) of the UWQOL has provided a good reliability and validity.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Hospital Anxiety and Depression Scale (HADS) - Taiwanese version (HADS-Depression subscale)
The 14-item HADS, developed to assess patients' anxiety and depression status, has 7 items that measure anxiety and 7 that measure depression. This scale has been widely used in cancer research to assess patients' psychological distress. The Taiwanese version of HADS has been developed and validated and showed promising psychometrics. In the proposed study, we will use this depression subscale to assess the depression affective dimension of patients' shoulder dysfunction.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Hospital Anxiety and Depression Scale (HADS) - Taiwanese version (HADS-Depression subscale)
The 14-item HADS, developed to assess patients' anxiety and depression status, has 7 items that measure anxiety and 7 that measure depression. This scale has been widely used in cancer research to assess patients' psychological distress. The Taiwanese version of HADS has been developed and validated and showed promising psychometrics. In the proposed study, we will use this depression subscale to assess the depression affective dimension of patients' shoulder dysfunction.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Fatigue Symptom Inventory (FSI)
We will use the FSI to assess both fatigue intensity (4 items) and fatigue interference (7 items). Psychometric testing of the FSI in cancer patients and healthy subjects showed good validity and reliability. Responses to these items are self-rated on an 11-point Likert-type scale (0=no fatigue at all/no interference; 10=extreme fatigue/extreme interference). The higher the score indicate the greater the levels of fatigue intensity and fatigue interference.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Fatigue Symptom Inventory (FSI)
We will use the FSI to assess both fatigue intensity (4 items) and fatigue interference (7 items). Psychometric testing of the FSI in cancer patients and healthy subjects showed good validity and reliability. Responses to these items are self-rated on an 11-point Likert-type scale (0=no fatigue at all/no interference; 10=extreme fatigue/extreme interference). The higher the score indicate the greater the levels of fatigue intensity and fatigue interference.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Background Information
Data from self-reported demographics (e.g., age and previous exercise behavior) and medical variables (e.g., cancer type, stage, and operation type) were collected.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Background Information
Data from self-reported demographics (e.g., age and previous exercise behavior) and medical variables (e.g., cancer type, stage, and operation type) were collected.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Perceived Barriers of Engaging Exercise
One open question to report barrier of engaging exercise.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The Karnofsky Performance Status (KPS)
The Karnofsky Performance Status (KPS) scores range from 0 to 100 and has been validated in terms of its reliability and validity.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The Karnofsky Performance Status (KPS)
The Karnofsky Performance Status (KPS) scores range from 0 to 100 and has been validated in terms of its reliability and validity.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Muscle strength
Using grip strength meter to measure the strength of right and left upper limbs; and will use microFET 2 to measure the strength of bilateral shoulder-muscle strength (shoulder flexion and horizontal abduction) and hip flexor muscle. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Muscle strength
Using grip strength meter to measure the strength of right and left upper limbs; and will use microFET 2 to measure the strength of bilateral shoulder-muscle strength (shoulder flexion and horizontal abduction) and hip flexor muscle. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Cervical range of motion (CROM)
The CROM was measured by using a "CROM device" (Performance Attainment Associates, St Paul, MN, USA). This CROM device has good reliability and validity. The CROM test evaluates the maximum degrees of neck forward flexion, extension, bilateral lateral flexion (right and left), and bilateral rotation (right and left). The procedure begins with warm-up exercises followed by maintaining a neutral position and moving the head naturally and without pain. Measuring two values and calculating the average.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Cervical range of motion (CROM)
The CROM was measured by using a "CROM device" (Performance Attainment Associates, St Paul, MN, USA). This CROM device has good reliability and validity. The CROM test evaluates the maximum degrees of neck forward flexion, extension, bilateral lateral flexion (right and left), and bilateral rotation (right and left). The procedure begins with warm-up exercises followed by maintaining a neutral position and moving the head naturally and without pain. Measuring two values and calculating the average.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Mouth opening
The normal range of jaw in HNC patients is 3.5. Past research has shown that vernier caliper is reliable tools for measuring mouth openings. The subjects sat upright and measured the distance between the mandibular incisors and the maxilla without feeling pain. Result expressed in centimeters.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Mouth opening
The normal range of jaw in HNC patients is 3.5. Past research has shown that vernier caliper is reliable tools for measuring mouth openings. The subjects sat upright and measured the distance between the mandibular incisors and the maxilla without feeling pain. Result expressed in centimeters.
Title:
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
SF-12 Health Survey (SF-12)
The 12-item SF-12 has eight subscales: physical functioning (2 items), role physical (2 items), role emotional (2 items), mental health (2 items), bodily pain (1 item), general health (1 item), and vitality (1 item), and social functioning (1 item). The SF-12 score include dichotomous items, and three, five-to-six point scales. Each subscale is scored from 0 to 100, with higher scores representing better function.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
SF-12 Health Survey (SF-12)
The 12-item SF-12 has eight subscales: physical functioning (2 items), role physical (2 items), role emotional (2 items), mental health (2 items), bodily pain (1 item), general health (1 item), and vitality (1 item), and social functioning (1 item). The SF-12 score include dichotomous items, and three, five-to-six point scales. Each subscale is scored from 0 to 100, with higher scores representing better function.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Brief Pain Inventory - Short Form (BPI-S)
The BPI-S, a self-report scale used to assess patients' pain experience, consists of two major parts, which measure pain intensity and pain interference. The 4-item pain intensity part measures worst pain intensity, pain intensity on average, least pain intensity, and current pain intensity. The 7-item pain interference part assesses the interference of pain on daily life. Each item is rated on a numerical scale from 0 ("no pain at all" or "no interference at all") to 10 ("worst possible pain I can imagine" for pain intensity or "extremely interfering"). The BPI-S has been found to be a reliable and valid measure of pain experience. The Chinese version of BPI-S has also showed promising psychometric characteristics.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Brief Pain Inventory - Short Form (BPI-S)
The BPI-S, a self-report scale used to assess patients' pain experience, consists of two major parts, which measure pain intensity and pain interference. The 4-item pain intensity part measures worst pain intensity, pain intensity on average, least pain intensity, and current pain intensity. The 7-item pain interference part assesses the interference of pain on daily life. Each item is rated on a numerical scale from 0 ("no pain at all" or "no interference at all") to 10 ("worst possible pain I can imagine" for pain intensity or "extremely interfering"). The BPI-S has been found to be a reliable and valid measure of pain experience. The Chinese version of BPI-S has also showed promising psychometric characteristics.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Symptom Severity Scale (SSS)
The SSS is a numeric scale that assesses the severity of common symptoms from 0 (no symptom at all) to 10 (as severe as possible), similar to other numeric rating scales of symptom severity. The SSS has been demonstrated as a reliable scale in cancer-related studies in Taiwan, with satisfactory content validity, face validity, and feasibility. The internal consistency reliability (Cronbach's alpha) ranged from .82 to .91.
Measured: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Symptom Severity Scale (SSS)
The SSS is a numeric scale that assesses the severity of common symptoms from 0 (no symptom at all) to 10 (as severe as possible), similar to other numeric rating scales of symptom severity. The SSS has been demonstrated as a reliable scale in cancer-related studies in Taiwan, with satisfactory content validity, face validity, and feasibility. The internal consistency reliability (Cronbach's alpha) ranged from .82 to .91.
Measured: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start22 Jan 2013
- Primary completion31 Dec 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- A pre- and post- study design was used to recruit patients. Data collection for usual care (control) group was completed before recruitment of exercise (intervention) group.
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Yeur-Hur Lai, Professor, Study chair, National Taiwan University Hos[ital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267353
- Sponsor's protocol ID
- 201209068RIC
- Status last verified
- Dec 2021
- First submitted
- 11 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
PubMed 11188601Williams JW Jr, Holleman DR Jr, Simel DL. Measuring shoulder function with the Shoulder Pain and Disability Index. J Rheumatol. 1995 Apr;22(4):727-32.
PubMed 7791172Yang JL, Lin JJ. Reliability of function-related tests in patients with shoulder pathologies. J Orthop Sports Phys Ther. 2006 Aug;36(8):572-6. doi: 10.2519/jospt.2006.2133.
PubMed 16915978Hassan 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 8253555Rogers SN, Scott B, Lowe D. An evaluation of the shoulder domain of the University of Washington quality of life scale. Br J Oral Maxillofac Surg. 2007 Jan;45(1):5-10. doi: 10.1016/j.bjoms.2006.09.007. Epub 2006 Nov 13.
PubMed 17101200Weymuller 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, Gwanne S, Lowe D, Humphris G, Yueh B, Weymuller EA Jr. The addition of mood and anxiety domains to the University of Washington quality of life scale. Head Neck. 2002 Jun;24(6):521-9. doi: 10.1002/hed.10106.
PubMed 12112548Lee 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 28214178Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Lampic C, von Essen L, Peterson VW, Larsson G, Sjoden PO. Anxiety and depression in hospitalized patients with cancer: agreement in patient-staff dyads. Cancer Nurs. 1996 Dec;19(6):419-28. doi: 10.1097/00002820-199612000-00002.
PubMed 8972974Lee Y, Wu YS, Chien CY, Fang FM, Hung CF. Use of the Hospital Anxiety and Depression Scale and the Taiwanese Depression Questionnaire for screening depression in head and neck cancer patients in Taiwan. Neuropsychiatr Dis Treat. 2016 Oct 13;12:2649-2657. doi: 10.2147/NDT.S112069. eCollection 2016.
PubMed 27789953Chen PY, See LC, Wang CH, Lai YH, Chang HK, & Chen ML. The impact of pain on the anxiety and depression of cancer patients. Formosan Journal of Medicine. 1999; 3: 373-382.
Cheng PT, Hao SP, Lin YH, Yeh AR. Objective comparison of shoulder dysfunction after three neck dissection techniques. Ann Otol Rhinol Laryngol. 2000 Aug;109(8 Pt 1):761-6. doi: 10.1177/000348940010900811.
PubMed 10961810Hsu C, Shen YC, Cheng CC, Hong RL, Chang CJ, Cheng AL. Difference in the incidence trend of nasopharyngeal and oropharyngeal carcinomas in Taiwan: implication from age-period-cohort analysis. Cancer Epidemiol Biomarkers Prev. 2006 May;15(5):856-61. doi: 10.1158/1055-9965.EPI-05-0821.
PubMed 16702360Hann DM, Jacobsen PB, Azzarello LM, Martin SC, Curran SL, Fields KK, Greenberg H, Lyman G. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998 May;7(4):301-10. doi: 10.1023/a:1024929829627.
PubMed 9610214
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School of Nursing, College of Medicine, National Taiwan University
- ClinicalTrials.gov ID
- NCT05267353
- Acronym / sponsor ID
- 201209068RIC
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck cancer, neck dissection, exercise intervention, quality of life, physical function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 22 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Mar 2022 (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 disease location and related treatments in head and neck areas following with concurrent chemoradiation therapy (CCRT), patients might suffer a series of acute distress and limit their physical activities. Limited physical activities might further cause dysfunction in both the upper body and general physical function.
Purposes: This 3-year project will be conducted for three folds, with the purposes to (1) longitudinally examine the upper body function (mouth open abilities/trismus, neck stiffness/flexibility, shoulder function, myofascial pain, and upper arm muscle strengths) and general physical fitness; and (2) develop a 20-week continuous exercise program and test of its effects on improving upper body function, general physical function, fatigue, and quality of life in operable HNC in the first year of being diagnosed as cancer.
Method: The eligible subjects will be newly diagnosed operable HNC patients. For research purpose (1) (Phase 1), we will conduct the data collection for continuous and follow patients for 12 months (Pre-operation, post-op 1, 3, 6, 12 months,/ T1-T5, respectively) for fatigue, upper body function and general physical fitness, and quality of life. A total of 130 subjects are planned to be recruited based on the sample size calculation. For research purpose (2) (Phase 2), from the second year, the 20-week "Multi-Faced Continuous Exercise Program" will be developed and tested in newly diagnosed operable HNC patients, while compare to those standard care control group of their differences in preventing physical dysfunction and increasing physical function for a 20-week period on post-op 1, 3, \& 6 months (T0-T2, respectively). Data will be analyzed by both descriptive analysis and the Generalized Estimating Equation (GEE). There will be 130 subjects in each group (N=260 total) based on power analysis principles.
Expected Outcome: The results will increase our knowledge about the changes in physical activities, physical function, and dysfunction; and the levels of the effectiveness of a continuous exercise program on increasing head and neck cancer patients' physical function and quality of life.
Detailed description
Head and neck squamous cell carcinoma (HNCSCC) is one of the most common cancers in Taiwan. The incidence is rapidly rising and is becoming the leading cause of death in men aged from 40-60 years in recent years. A multimodal treatment approach has led to a relatively good five-year survival rate in HNC patients ranging from 40% to over 50%. A review showed that over the past 10 years, the 5-year survival rate for HNC has increased from 55% to 66%. In other words, with the increasing number of head and neck cancer patients in Taiwan, a rapidly increasing number of survivors and the survival issues related to head and neck cancers are critically necessary to care.
Except those in severe metastasis or terminal condition and those in stage I, the majority of head and neck cancers patients receive a series of treatments, including tumor resection, neck dissection (ND), even reconstruction with free-flap surgery, and CCRT. Due to the disease location and surgery in head and neck areas, many head and neck cancer patients suffer problems in the upper body, particularly head, neck, and shoulder areas. Pain in these areas may cause diminishing function in the upper extremities and weaken the muscle power in the upper extremities.
After the acute distress, patients may also face some long-term problems if those acute problems are not well cared, such as myofascial pain in neck and shoulder areas, trismus from local radiation, and tightness of shoulder. Fatigue and generally declined physical function may also be found to be fatigue, decreasing of physical function, and general malaise. Thus, these declining functions, including both upper extremities and a general weakening in physical function, may further influence patients' physical activities, daily life, and even employment status. It would be therefore very important to systematically assess and intervene in these problems to decrease patients' dysfunction and increase their physical function and quality of life.
Unfortunately, those disease or treatment-related functional declines and decreasing physical activities due to treatments or limited physical conditions may not receive sufficient attention from both health care professionals and patients. Clinically, the major focus has been on treating the life-threatening head and neck cancer, the disease itself. For example, a study was done in UK found that only 8.5% of head and neck cancer survivors reported doing sufficient physical activities which met the current suggested exercise guideline. Very few HNC patients participated in moderate-intensity to vigorous-intensity physical activity. While HNC patients in Taiwan received exercise recommendations before RT, only 16.7% followed WHO exercise recommendations and 14% continued stretching after RT.
Concerning the increasing numbers of head and neck cancer patients and survivors, and the gradually developed physical dysfunction, it would be very important to longitudinally examine the changes of those problems (upper body and general physical function and status of applying physical activities, preferences, and barriers of applying physical activities) during the cancer process. The data would be helpful to develop an evidence-based, brief, easily carried out and comprehensive exercise program that may cover the exercise needs across the cancer process, particularly for the first 6 months of diagnosis (acute treatment phase to off treatment survival phase).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre- and post- study design was used to recruit patients. Data collection for usual care (control) group was completed before recruitment of exercise (intervention) group.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –All patients received care as usual. Patients receive wound care and pain management post-surgery. Before RT, generally advising to do neck stretch and mouth opening exercises. Telephone follow-up was not provided to usual care group. Furthermore, patients in usual care group went to receive physical therapy were free to do. During the follow-up period, well-trained research nurses (assessors) recorded their physical therapy sections. |
| Exercise intervention programs | Experimental | Behavioral: Exercise intervention programBased on our previous literature review, we will have two major parts of exercises in our intervention: (1) Upper Body Exercise (stretching in shoulder and neck, and mouth-opening); and (2) General Physical Function Training. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible subjects were adult patients (≥20 years old) with newly diagnosed squamous cell type of HNC patients who received tumor excision and neck dissection (either MRND or SND) within 3-4 weeks
- Part of subjects might with postoperative RT or CCRT
Key exclusion criteria (1 listed)
- Patients unable to communicate
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 |
|---|---|---|
| Exercise intervention programIt was developed, along with usual care, to prevent restricted ROM in both upper body and limited general physical functioning. Patients in exercise intervention group received verbal instructions about stretching major muscles and phsical activity recommendations from a trained nurse (intervenor), and then received the booklet plus DVD. The physical therapist who developed and adjusted this program also trained the intervenor. After verifying the intervenor has performed exercise interventions were consistent with the physical therapist, he/she was responsible for all interventions. Therefore, if pain or discomfort persists for more than an hour, the patient should inform the intervenor. The intervention group patients also received telephone follow-up from the intervenor every two weeks until the end of the intervention. | Behavioural | Exercise intervention programs |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The 13-item SPADI is composed of two subscales which include pain (5 items), and disability (8 items). The scale is a visual analogue scale, ranging from 0-10 cm, with 0 representing "no difficulty (left anchor)" and 10 representing "so difficult required help (right anchor)". The SPADI total score ranges from 0 to 100 and is obtained by averaging the pain and disability subscale scores. Higher scores indicate greater pain and greater disability. The psychometric testing in a previous study has been reported. The Taiwanese version psychometric testing and scoring in a previous study has been reported.
University of Washington- Quality of Life (UW-QOL)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
University of Washington - Quality of Life (UW-QOL) was characterized of its simplicity and developed to quickly assess head and neck cancer patients' health related QOL. Four versions have been developed since 1993. The current version, UW-QOL version 4 contains 12 items that to assess 12 domains of QOL in head and neck cancer patients. It has been translated into Chinese and tested for its psychometrics in head and neck cancer populations in Taiwan and the 13-item Chinese version (including employment status) of the UWQOL has provided a good reliability and validity.
University of Washington- Quality of Life (UW-QOL)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
University of Washington - Quality of Life (UW-QOL) was characterized of its simplicity and developed to quickly assess head and neck cancer patients' health related QOL. Four versions have been developed since 1993. The current version, UW-QOL version 4 contains 12 items that to assess 12 domains of QOL in head and neck cancer patients. It has been translated into Chinese and tested for its psychometrics in head and neck cancer populations in Taiwan and the 13-item Chinese version (including employment status) of the UWQOL has provided a good reliability and validity.
Hospital Anxiety and Depression Scale (HADS) - Taiwanese version (HADS-Depression subscale)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The 14-item HADS, developed to assess patients' anxiety and depression status, has 7 items that measure anxiety and 7 that measure depression. This scale has been widely used in cancer research to assess patients' psychological distress. The Taiwanese version of HADS has been developed and validated and showed promising psychometrics. In the proposed study, we will use this depression subscale to assess the depression affective dimension of patients' shoulder dysfunction.
Hospital Anxiety and Depression Scale (HADS) - Taiwanese version (HADS-Depression subscale)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The 14-item HADS, developed to assess patients' anxiety and depression status, has 7 items that measure anxiety and 7 that measure depression. This scale has been widely used in cancer research to assess patients' psychological distress. The Taiwanese version of HADS has been developed and validated and showed promising psychometrics. In the proposed study, we will use this depression subscale to assess the depression affective dimension of patients' shoulder dysfunction.
Fatigue Symptom Inventory (FSI)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
We will use the FSI to assess both fatigue intensity (4 items) and fatigue interference (7 items). Psychometric testing of the FSI in cancer patients and healthy subjects showed good validity and reliability. Responses to these items are self-rated on an 11-point Likert-type scale (0=no fatigue at all/no interference; 10=extreme fatigue/extreme interference). The higher the score indicate the greater the levels of fatigue intensity and fatigue interference.
Fatigue Symptom Inventory (FSI)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
We will use the FSI to assess both fatigue intensity (4 items) and fatigue interference (7 items). Psychometric testing of the FSI in cancer patients and healthy subjects showed good validity and reliability. Responses to these items are self-rated on an 11-point Likert-type scale (0=no fatigue at all/no interference; 10=extreme fatigue/extreme interference). The higher the score indicate the greater the levels of fatigue intensity and fatigue interference.
Background Information
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Data from self-reported demographics (e.g., age and previous exercise behavior) and medical variables (e.g., cancer type, stage, and operation type) were collected.
Background Information
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Data from self-reported demographics (e.g., age and previous exercise behavior) and medical variables (e.g., cancer type, stage, and operation type) were collected.
Perceived Barriers of Engaging Exercise
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
One open question to report barrier of engaging exercise.
The Karnofsky Performance Status (KPS)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The Karnofsky Performance Status (KPS) scores range from 0 to 100 and has been validated in terms of its reliability and validity.
The Karnofsky Performance Status (KPS)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The Karnofsky Performance Status (KPS) scores range from 0 to 100 and has been validated in terms of its reliability and validity.
Muscle strength
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Using grip strength meter to measure the strength of right and left upper limbs; and will use microFET 2 to measure the strength of bilateral shoulder-muscle strength (shoulder flexion and horizontal abduction) and hip flexor muscle. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies.
Muscle strength
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Using grip strength meter to measure the strength of right and left upper limbs; and will use microFET 2 to measure the strength of bilateral shoulder-muscle strength (shoulder flexion and horizontal abduction) and hip flexor muscle. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies.
Cervical range of motion (CROM)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The CROM was measured by using a "CROM device" (Performance Attainment Associates, St Paul, MN, USA). This CROM device has good reliability and validity. The CROM test evaluates the maximum degrees of neck forward flexion, extension, bilateral lateral flexion (right and left), and bilateral rotation (right and left). The procedure begins with warm-up exercises followed by maintaining a neutral position and moving the head naturally and without pain. Measuring two values and calculating the average.
Cervical range of motion (CROM)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The CROM was measured by using a "CROM device" (Performance Attainment Associates, St Paul, MN, USA). This CROM device has good reliability and validity. The CROM test evaluates the maximum degrees of neck forward flexion, extension, bilateral lateral flexion (right and left), and bilateral rotation (right and left). The procedure begins with warm-up exercises followed by maintaining a neutral position and moving the head naturally and without pain. Measuring two values and calculating the average.
Mouth opening
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The normal range of jaw in HNC patients is 3.5. Past research has shown that vernier caliper is reliable tools for measuring mouth openings. The subjects sat upright and measured the distance between the mandibular incisors and the maxilla without feeling pain. Result expressed in centimeters.
Mouth opening
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The normal range of jaw in HNC patients is 3.5. Past research has shown that vernier caliper is reliable tools for measuring mouth openings. The subjects sat upright and measured the distance between the mandibular incisors and the maxilla without feeling pain. Result expressed in centimeters. Title:
SF-12 Health Survey (SF-12)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The 12-item SF-12 has eight subscales: physical functioning (2 items), role physical (2 items), role emotional (2 items), mental health (2 items), bodily pain (1 item), general health (1 item), and vitality (1 item), and social functioning (1 item). The SF-12 score include dichotomous items, and three, five-to-six point scales. Each subscale is scored from 0 to 100, with higher scores representing better function.
SF-12 Health Survey (SF-12)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The 12-item SF-12 has eight subscales: physical functioning (2 items), role physical (2 items), role emotional (2 items), mental health (2 items), bodily pain (1 item), general health (1 item), and vitality (1 item), and social functioning (1 item). The SF-12 score include dichotomous items, and three, five-to-six point scales. Each subscale is scored from 0 to 100, with higher scores representing better function.
Brief Pain Inventory - Short Form (BPI-S)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The BPI-S, a self-report scale used to assess patients' pain experience, consists of two major parts, which measure pain intensity and pain interference. The 4-item pain intensity part measures worst pain intensity, pain intensity on average, least pain intensity, and current pain intensity. The 7-item pain interference part assesses the interference of pain on daily life. Each item is rated on a numerical scale from 0 ("no pain at all" or "no interference at all") to 10 ("worst possible pain I can imagine" for pain intensity or "extremely interfering"). The BPI-S has been found to be a reliable and valid measure of pain experience. The Chinese version of BPI-S has also showed promising psychometric characteristics.
Brief Pain Inventory - Short Form (BPI-S)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The BPI-S, a self-report scale used to assess patients' pain experience, consists of two major parts, which measure pain intensity and pain interference. The 4-item pain intensity part measures worst pain intensity, pain intensity on average, least pain intensity, and current pain intensity. The 7-item pain interference part assesses the interference of pain on daily life. Each item is rated on a numerical scale from 0 ("no pain at all" or "no interference at all") to 10 ("worst possible pain I can imagine" for pain intensity or "extremely interfering"). The BPI-S has been found to be a reliable and valid measure of pain experience. The Chinese version of BPI-S has also showed promising psychometric characteristics.
Symptom Severity Scale (SSS)
Time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
The SSS is a numeric scale that assesses the severity of common symptoms from 0 (no symptom at all) to 10 (as severe as possible), similar to other numeric rating scales of symptom severity. The SSS has been demonstrated as a reliable scale in cancer-related studies in Taiwan, with satisfactory content validity, face validity, and feasibility. The internal consistency reliability (Cronbach's alpha) ranged from .82 to .91.
Symptom Severity Scale (SSS)
Time frame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
The SSS is a numeric scale that assesses the severity of common symptoms from 0 (no symptom at all) to 10 (as severe as possible), similar to other numeric rating scales of symptom severity. The SSS has been demonstrated as a reliable scale in cancer-related studies in Taiwan, with satisfactory content validity, face validity, and feasibility. The internal consistency reliability (Cronbach's alpha) ranged from .82 to .91.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 11188601Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
- Background: PubMed 7791172Williams JW Jr, Holleman DR Jr, Simel DL. Measuring shoulder function with the Shoulder Pain and Disability Index. J Rheumatol. 1995 Apr;22(4):727-32.
- Background: PubMed 16915978Yang JL, Lin JJ. Reliability of function-related tests in patients with shoulder pathologies. J Orthop Sports Phys Ther. 2006 Aug;36(8):572-6. doi: 10.2519/jospt.2006.2133.
- 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 17101200Rogers SN, Scott B, Lowe D. An evaluation of the shoulder domain of the University of Washington quality of life scale. Br J Oral Maxillofac Surg. 2007 Jan;45(1):5-10. doi: 10.1016/j.bjoms.2006.09.007. Epub 2006 Nov 13.
- 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 12112548Rogers SN, Gwanne S, Lowe D, Humphris G, Yueh B, Weymuller EA Jr. The addition of mood and anxiety domains to the University of Washington quality of life scale. Head Neck. 2002 Jun;24(6):521-9. doi: 10.1002/hed.10106.
- 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 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 8972974Lampic C, von Essen L, Peterson VW, Larsson G, Sjoden PO. Anxiety and depression in hospitalized patients with cancer: agreement in patient-staff dyads. Cancer Nurs. 1996 Dec;19(6):419-28. doi: 10.1097/00002820-199612000-00002.
- Background: PubMed 27789953Lee Y, Wu YS, Chien CY, Fang FM, Hung CF. Use of the Hospital Anxiety and Depression Scale and the Taiwanese Depression Questionnaire for screening depression in head and neck cancer patients in Taiwan. Neuropsychiatr Dis Treat. 2016 Oct 13;12:2649-2657. doi: 10.2147/NDT.S112069. eCollection 2016.
- BackgroundChen PY, See LC, Wang CH, Lai YH, Chang HK, & Chen ML. The impact of pain on the anxiety and depression of cancer patients. Formosan Journal of Medicine. 1999; 3: 373-382.
- 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
National Taiwan University Hos[ital
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention program in people with Head and Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital.
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 1 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) (time frame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)). The study lists 24 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 NCT05267353, which also lists 47 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 4 Mar 2022.