ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 1330 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation (NEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443258
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborators:
Novo Nordisk A/S
Danish Nurses Organisation
Information provided by (Responsible Party):
Annelise Mortensen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Other: Needs assesment tool integrated in nursing consultation. Not Applicable

Detailed Description:
The study tests a needs assessment and decision-making tool with patients surgically treated for Head and Neck Cancer. The tool will be an integrated part of a new clinical practice with nursing consultations at three seperate time-points in the post-surgical period of the patients. Half of the participants will receive nursing consultations using the tool and the other half will receive standard care.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Needs Assessment and Decision-making Tool (NEAT-decision) Integrated in a Clinical Practice to Enhance Patient Involvement in Head and Neck Cancer Rehabilitation - a Randomized Controlled Trial
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group (IG)
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.
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

No Intervention: Control Group (CG)
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



Primary Outcome Measures :
  1. Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery [ Time Frame: Baseline; 9; 21 and 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


Secondary Outcome Measures :
  1. Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery [ Time Frame: Baseline, 2, 14 and 60 days post-surgery ]
    Questionnaire measuiring 28 items related to symptoms of head and neck cancer patients. MD Anderson Symptom Inventory Head and Neck Cancer module (MDASI-HN). Scores range from 0 - 10, where a high score represents a high symptom burden interference with daily life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443258


Contacts
Contact: Bloch Jensen 45 3545 1244 tine.bloch.jensen.01@regionh.dk
Contact: Mary Jarden, PhD 45 3545 4368 mary.jarden@regionh.dk

Locations
Denmark
Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology Recruiting
Copenhagen, Denmark
Contact: Bloch Jensen    45 3545 1244    tine.bloch.jensen.01@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Novo Nordisk A/S
Danish Nurses Organisation
Investigators
Principal Investigator: Annelise Mortensen, MSA Rigshospitalet, Denmark
  Study Documents (Full-Text)

Documents provided by Annelise Mortensen, Rigshospitalet, Denmark:
Study Protocol  [PDF] January 31, 2018


Responsible Party: Annelise Mortensen, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03443258     History of Changes
Other Study ID Numbers: 05781
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms