Clinical trial NCT05267353: Develop and Test the 'Multi-Faced Continuous Exercise Program' in Operable Head and Neck Cancer Patients
Official title: School of Nursing, College of Medicine, National Taiwan University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: head and neck cancer
neck dissection
exercise intervention
quality of life
physical function
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2022-03-04
Enrollment: 390
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: University of Washington- Quality of Life (UW-QOL)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: University of Washington- Quality of Life (UW-QOL)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Hospital Anxiety and Depression Scale (HADS) - Taiwanese version (HADS-Depression subscale)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Hospital Anxiety and Depression Scale (HADS) - Taiwanese version (HADS-Depression subscale)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Fatigue Symptom Inventory (FSI)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Fatigue Symptom Inventory (FSI)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Background Information
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Background Information
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Perceived Barriers of Engaging Exercise
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: The Karnofsky Performance Status (KPS)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: The Karnofsky Performance Status (KPS)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Muscle strength
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Muscle strength
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Cervical range of motion (CROM)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Cervical range of motion (CROM)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Mouth opening
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Mouth opening
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: SF-12 Health Survey (SF-12)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: SF-12 Health Survey (SF-12)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Brief Pain Inventory - Short Form (BPI-S)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Brief Pain Inventory - Short Form (BPI-S)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
measure: Symptom Severity Scale (SSS)
timeFrame: Phase 1: Change from Baseline (pre-operation) to post-operation 12 months (measured 5 times)
measure: Symptom Severity Scale (SSS)
timeFrame: Phase 2: Change from Baseline (post-op 1 month) to post-op 6 months (measured 3 times)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hos[ital
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
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