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

NCT ID: NCT05269342

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2018-09-09

Brief 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.

Detailed 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

Conditions

Head and Neck Cancer; Cancer of Head and Neck; Head and Neck Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

the nurse-led counseling and after intervention exercise

The NUCAI aims to help patients manage themselves physically and psychologically by giving support, education, and exercise tracking.

The participants in the control group were care as usual.Intervention group were the nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC.

Group Type: EXPERIMENTAL

nurse-led counseling and after intervention

Intervention Type: BEHAVIORAL

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

Interventions

nurse-led counseling and after intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

YU LONG HONG

OTHER

Sponsor Role: lead

Responsible Party

YU LONG HONG

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Yu Long Hong

Hualien City, , Taiwan

Countries

Taiwan

Other Identifiers

HYL

Identifier Type: -

Identifier Source: org_study_id