NCT03443258

Brief Summary

The study tests a needs assessment and decision-making tool with patients who are in need of rehabilitation after surgery for Head and Neck Cancer. The purpose is to enhance patient involvement in decision-making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

October 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

January 31, 2018

Last Update Submit

October 8, 2020

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery

    Questionnaire measuring 35 items related to quality of life in head and neck cancer. European Organisation for Research and Treatment of Cancer Quality of Life and Head and Neck Cancer (EORTC QLQ-H\&N35). Scores range from 0 - 100,, where a high score represents high quality of life. The study will measure global quality of life

    Baseline; 9; 21 and 67 days post-surgery

Secondary Outcomes (1)

  • Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery

    Baseline, 2, 14 and 60 days post-surgery

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Patients receive needs assessment tool integrated in nursing consultation in accordance with requirements by Danish Health and Medicine Board follow-up program for HNC patients. The consultation consists of 6 steps 1. Welcoming patient; 2. Introducing patient to assessment tool; 3. Discuss symptoms and concerns patient wishes to discuss; 4. Follow up on patients symptoms, concerns and emotional reactions/problems; 5. Accompany/support patient during appointment with surgeon and in cooperation with patient and surgeon ensure that problems arising from the tool needing medical attention are focused on; 6. Continue the consultation after appointment with surgeon; refer patient to multi-disciplinary team members when needed

Other: Needs assesment tool integrated in nursing consultation.

Control Group (CG)

NO INTERVENTION

CG will receive standard care according to the Danish Health and Medicine Board's follow-up program for HNC patients. At present this is done by a staff nurse interviewing the patient, who is a member of the rehabilitation team who perform nursing consultations. The interview takes place after the appointment with the surgeon. The nurse refers the patient to physical rehabilitation if needed

Interventions

Needs assesment tool integrated in nursing consultation.OTHER

Needs assessment tool consisting of 57 items related to functional, emotional, social and existential areas guide follow-up care and referral to multidisciplinary team rehabilitation e.g. dietician; speech-pathologist; psychologist, etc

Intervention Group (IG)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Head and Neck Cancer
  • Stage T3 or T4
  • Surgically treated
  • Must be able to speak and understand Danish

You may not qualify if:

  • Treated surgically for thyroid or parotic cancers
  • Referred to adjuvant radio - or chemotherapy
  • Having an unstable psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology

Copenhagen, Denmark

Location

Related Publications (1)

  • Mortensen A, Wessel I, Rogers SN, Tolver A, Jarden M. Needs assessment in patients surgically treated for head and neck cancer-a randomized controlled trial. Support Care Cancer. 2022 May;30(5):4201-4218. doi: 10.1007/s00520-021-06759-9. Epub 2022 Jan 27.

    PMID: 35083545DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Annelise Mortensen, MSA

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients are assigned to either intervention or control group. The intervention group receives a nursing consultation using a need assessment and decision making tool. The control group receives usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 23, 2018

Study Start

June 11, 2018

Primary Completion

November 15, 2019

Study Completion

November 30, 2019

Last Updated

October 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)