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

NCT ID: NCT05267353

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-22
• Study Completion Date: 2022-12-31

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).

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise intervention programs

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.

Group Type: EXPERIMENTAL

Exercise intervention program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yeur-Hur Lai, Professor

Role: STUDY_CHAIR

National Taiwan University Hos[ital

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Other Identifiers

201209068RIC

Identifier Type: -

Identifier Source: org_study_id