NCT04322695

Brief Summary

The purpose of this study will to identify factors (performance ability, physical function, psychosocial function, fear of cancer progression, social support, demographic characteristics, and disease-related characteristics) that impact the Return to work and work status in survivors of HNC within one year after completion treatment. Head and neck cancer survivors who have attended a rehabilitation education care program (RECP) intervention will have better performance ability, physical function, psychosocial function, fear of cancer progress, social support, and lower return to work to patients who not attended with the intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 31, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

March 23, 2020

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change barrier to return to work

    Return to Work Barrier Scale (RTWBS)

    3 months, 6 months, and 12 months

Secondary Outcomes (3)

  • Change fear of cancer progress

    3 months, 6 months, and 12 months

  • Change social support

    3 months, 6 months, and 12 months

  • Change quality of life

    3 months, 6 months, and 12 months

Study Arms (2)

Rehabilitation Education Care Program (RECP)

EXPERIMENTAL

Cancer rehabilitation program and patients education can improve disability and promote return to work.

Behavioral: Rehabilitation Education Care Program

Usual care

OTHER

Usual care

Behavioral: Rehabilitation Education Care Program

Interventions

The RECP contained the following domains: (1) assessment and detection of disability; (2) home exercise; (3) activities to improve mobility; (4) dietary management; (5) patient education; and (6) vocational counseling.

Rehabilitation Education Care Program (RECP)Usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of head and neck cancer.
  • Must be age were greater than 18 years and less than 64.5 years
  • Must be able to better performance status and KPS score more than 60
  • Must be had completion of treatment more than 3 months

You may not qualify if:

  • Unemployment or retire at the time of cancer diagnosis
  • unstable systemic disease
  • Poor performance status and KPS score less than 60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shu-Ching Chen

Taoyuan District, Taiwan

Location

Related Publications (1)

  • Chang YL, Huang BS, Lin CY, Chung CF, Chen SC. Effects of a return to work program on the health and barriers to returning to work in head and neck cancer patients: A randomized controlled trial. Asia Pac J Oncol Nurs. 2023 Oct 17;10(12):100320. doi: 10.1016/j.apjon.2023.100320. eCollection 2023 Dec.

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 26, 2020

Study Start

July 31, 2021

Primary Completion

July 30, 2023

Study Completion

July 31, 2023

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations