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

Sponsor
YU LONG HONG (Other)
Overall Status
Completed
CT.gov ID
NCT05269342
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
11.8
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: nurse-led counseling and after intervention
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Sep 14, 2017
Actual Primary Completion Date :
Jun 16, 2018
Actual Study Completion Date :
Sep 9, 2018

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. Demographic and Illness-related Information [2 weeks preoperatively]

    age, sex, educational level, and cancer stage

Secondary Outcome Measures

  1. shoulder pain and disability indices [2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively]

    shoulder pain and disability

Other Outcome Measures

  1. the University of Washington Quality of Life Questionnaire (UW-QOL) [2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively]

    Quality of Life

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yu Long Hong Hualien City Taiwan

Sponsors and Collaborators

  • YU LONG HONG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YU LONG HONG, Principal Investigator, Hualien Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT05269342
Other Study ID Numbers:
  • HYL
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by YU LONG HONG, Principal Investigator, Hualien Tzu Chi General Hospital
Head and Neck Neoplasms
Additional relevant MeSH terms:
Head and Neck Neoplasms
Shoulder Pain

Study Results

No Results Posted as of Mar 8, 2022