NCT05269342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

February 18, 2022

Last Update Submit

March 1, 2022

Conditions

Keywords

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Demographic and Illness-related Information

    age, sex, educational level, and cancer stage

    2 weeks preoperatively

Secondary Outcomes (1)

  • shoulder pain and disability indices

    2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively

Other Outcomes (1)

  • the University of Washington Quality of Life Questionnaire (UW-QOL)

    2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively

Study Arms (1)

the nurse-led counseling and after intervention exercise

EXPERIMENTAL

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

Interventions

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

the nurse-led counseling and after intervention exercise

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu Long Hong

Hualien City, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 8, 2022

Study Start

September 14, 2017

Primary Completion

June 16, 2018

Study Completion

September 9, 2018

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations