- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05269342
Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hualien City, Taiwan
- Yu Long Hong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicCompletedCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
West China HospitalNot yet recruitingHead and Neck Cancer | Malignant Neoplasm | Advanced Head and Neck Carcinoma | Head &Amp; Neck Cancer
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Fondazione IRCCS Policlinico San Matteo di PaviaNestle Health Science; Akern SrlCompletedHead-neck CancerItaly
-
Radboud University Medical CenterUnknown
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Uppsala UniversityRegion Östergötland; Region Skane; Region Västerbotten; Swedish Cancer Society; S... and other collaboratorsNot yet recruitingHead and Neck Cancer | Head and Neck Cancer Squamous Cell CarcinomaSweden
Clinical Trials on nurse-led counseling and after intervention
-
Chinese University of Hong KongHenan Provincial People's HospitalCompletedHepatitis B | Hepatocellular CarcinomaChina
-
Assistance Publique - Hôpitaux de ParisCompletedRheumatoid Arthritis (RA) | Spondyloarthritis (SpA)France
-
Hellenic Mediterranean UniversityRecruiting
-
Fujian Cancer HospitalNot yet recruitingNasopharyngeal Carcinoma
-
Hellenic Mediterranean UniversityCompletedGlaucoma | Health Literacy | Patient ActivationGreece
-
Dokuz Eylul UniversityCompleted
-
University of UtahCompletedPain | Osteoarthritis, Knee | Osteoarthritis, HipUnited States
-
Weill Medical College of Cornell UniversityNational Cancer Institute (NCI)CompletedBreast Cancer | PreDiabetes | Type 2 DiabetesUnited States
-
Complejo Hospitalario Universitario de AlbaceteCompleted