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

March 1, 2022 updated by: YU LONG HONG

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

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hualien City, Taiwan
        • Yu Long Hong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic and Illness-related Information
Time Frame: 2 weeks preoperatively
age, sex, educational level, and cancer stage
2 weeks preoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder pain and disability indices
Time Frame: 2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively
shoulder pain and disability
2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the University of Washington Quality of Life Questionnaire (UW-QOL)
Time Frame: 2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively
Quality of Life
2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Actual)

June 16, 2018

Study Completion (Actual)

September 9, 2018

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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