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

Primary Purpose

Head and Neck Cancer, Cancer of Head and Neck, Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
nurse-led counseling and after intervention
Sponsored by
YU LONG HONG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Head and Neck Neoplasms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yu Long Hong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the nurse-led counseling and after intervention exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Demographic and Illness-related Information
age, sex, educational level, and cancer stage

Secondary Outcome Measures

shoulder pain and disability indices
shoulder pain and disability

Full Information

First Posted
February 18, 2022
Last Updated
March 1, 2022
Sponsor
YU LONG HONG
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1. Study Identification

Unique Protocol Identification Number
NCT05269342
Brief Title
Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
June 16, 2018 (Actual)
Study Completion Date
September 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YU LONG HONG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Cancer of Head and Neck, Head and Neck Neoplasms
Keywords
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the nurse-led counseling and after intervention exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
nurse-led counseling and after intervention
Intervention Description
the nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC
Primary Outcome Measure Information:
Title
Demographic and Illness-related Information
Description
age, sex, educational level, and cancer stage
Time Frame
2 weeks preoperatively
Secondary Outcome Measure Information:
Title
shoulder pain and disability indices
Description
shoulder pain and disability
Time Frame
2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively
Other Pre-specified Outcome Measures:
Title
the University of Washington Quality of Life Questionnaire (UW-QOL)
Description
Quality of Life
Time Frame
2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Yu Long Hong
City
Hualien City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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