Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Nurse-led Exercise To Improve Shoulder Pain, Shoulder Disability, and Quality of Life in Postoperative Patients With Newly Diagnosed Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269342
• Other study ID #: HYL
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: September 9, 2018

Study information

• Verified date: March 2022
• Source: Hualien Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: This study aimed to the postoperative patients with newly diagnosed head and neck Cancer. The nurse-led counselling and after intervention improved shoulder pain, Shoulder Disability, and Quality of Life., before 2 weeks radical neck dissection and at postoperative 2, 4, 8, and 12 weeks.

Methods：Participants were identified for eligibility from the otorhinolaryngology outpatient department of a medical center in eastern Taiwan. The data of 40 patients were collected between Aug 1, 2017, and Jul 31, 2018. 40 participants were randomly assigned to an experimental (n = 20) and a control group (n = 20). The experimental group received the nurse counselling and after intervention exercise intervention , and the control group received usual care. Study tools used were the shoulder pain and disability indices, University of Washington Quality of Life Questionnaire.

Description:

Head and neck cancer (HNCs) is malignancies . Globally, HNCs was the seventh most common cancer in 2018. In taiwan, have high incidences . Primary treatments for HNCs are surgery alone or in combination with radiation . The radical neck dissection and radiotherapy inevitably damage nerves and muscles, resulting in various complications such as shoulder pain and disability; the shoulder disability and chronic neck pain occur following radical neck dissection, these complications may considerably limit the individual's capacity to undertake various tasks, affecting daily physical activities. Immediate postoperative rehabilitation has been advocated to improve these complications in HNC participants . But rticipants often fail to achieve this thresh old, which emphasizes the need to change their inactive behaviour.

Nurses are involved in patient care and have the necessary skills and knowledge about the medical and practical aspects of head and neck cancer treatment . Nurses can provide information, support and coaching to HNC participants .Nurses are in a key position to deliver an intervention to improve QoL . The investigators designed a randomised controlled trial (RCT) to investigate the effectiveness of a comprehensive 12weeks nurse-led intervention, the nurse counselling and after intervention (NUCAI), in HNC participants follow exercise intervention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 9, 2018
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

aged >20 years old newly diagnosed with HNC scheduled to receive surgery had no serious complications had no history of mental illness had no comorbidities had no sensory-cognitive problems could understand Chinese or Taiwanese

Exclusion criteria:

could not communicate or comprehend the questionnaires had a history of shoulder dysfunction before neck dissection had preexisting shoulder pain, dysfunction, or weakness had any disorders that could influence movement performance.

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Cancer
• Head and Neck Neoplasms
• Shoulder Pain

Intervention

Behavioral:
• nurse-led counseling and after intervention
the nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC

Locations

Country	Name	City	State
Taiwan	Yu Long Hong	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
YU LONG HONG

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the University of Washington Quality of Life Questionnaire (UW-QOL)	Quality of Life	2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively
Primary	Demographic and Illness-related Information	age, sex, educational level, and cancer stage	2 weeks preoperatively
Secondary	shoulder pain and disability indices	shoulder pain and disability	2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively