Develop and Test the 'Multi-Faced Continuous Exercise Program' in Operable Head and Neck Cancer Patients

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

School of Nursing, College of Medicine, National Taiwan University

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05267353
• Other study ID #: 201209068RIC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 22, 2013
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients unable to communicate

Related Conditions & MeSH terms

• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Behavioral:
• Exercise intervention program
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	Perceived Barriers of Engaging Exercise	One open question to report barrier of engaging exercise.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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:	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Primary	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.	Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
Primary	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.	Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)