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Nurse-led Follow-up Care for Head and Neck Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167179
First Posted: July 22, 2010
Last Update Posted: December 15, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacqueline de Leeuw, Radboud University
Results First Submitted: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Head and Neck Cancer
Intervention: Behavioral: nurse-led consultation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: November 2007 to February 2010. Setting: outpatient oncology clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The eligibility criteria for the study were as follows: informed of a HNC diagnosis (but no other cancer); to be treated with curative intent; to be able to speak, write and understand Dutch; and be cognitively able to provide informed consent. Exclusion criteria included overt psychopathology, alcohol addiction, life expectancy of less than 6 mo.

Reporting Groups
  Description
Usual Care The participants in the usual care group received care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in usual care.
Intervention

The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model.The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation. Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.

During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.


Participant Flow:   Overall Study
    Usual Care   Intervention
STARTED   80   80 
COMPLETED   65   59 
NOT COMPLETED   15   21 
disease recurrence                4                4 
Death                4                10 
Withdrawal by Subject                1                2 
diverse                6                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care The participants in the comparison group received usual care that consisted of a 5-year routine control schedule with six bimonthly 10-minute visits to a head and neck surgeon in the first year posttreatment in accordance with national guidelines.19 Nursing follow-up care consisted of ad hoc problem-based contacts except for patients who underwent a laryngectomy, who received standard nursing consultations during the first 6 months posttreatment in parallel with the medical control visits. Patients who were treated with surgery alone all had one standard wound control visit with a nurse; patients who were treated with radiotherapy had one to six ad hoc nursing contacts during the first 6 months posttreatment. For the duration of the study, there were no changes in conventional care.
Intervention The intervention consisted of six 30-minute nursing follow-up consultations in the first year posttreatment. A standardized protocol was used for this purpose. Nursing consultations were conducted in parallel with and preceding the medical routine control visits and included a needs assessment based upon the biopsychosocial model. The aim of consultation was to give advice and support to patients (and their partners) addressing the physical and psychosocial consequences of treatment. To increase patient focus and active participation during consultations, patients completed a 13-item checklist prior to each consultation.Every 3 months, patients were screened for psychosocial problem areas using a specific questionnaire.During the consultations, the nurses also performed simple medical checks including inspection of the tracheal stoma, cannula and speech valve (if applicable), and oral cavity, and palpation of the neck and lymph nodes.
Total Total of all reporting groups

Baseline Measures
   Usual Care   Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   80   160 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      68  85.0%      69  86.3%      137  85.6% 
>=65 years      12  15.0%      11  13.8%      23  14.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.4  (13.0)   59.2  (12.3)   58.8  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  25.0%      26  32.5%      46  28.7% 
Male      60  75.0%      54  67.5%      114  71.3% 
Region of Enrollment 
[Units: Participants]
     
Netherlands   80   80   160 
Psychosocial adjustment [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 46  (12)   50  (11)   49  (12) 
[1] Psychosocial Adjustment to Illness Scale – Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. The Dutch validated questionnaire was used.HRQOL was measured with the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire with additional Head & Neck Module (EORTC QLQ-C30 and QLQ-H&N35).
Quality of Life [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 76  (17)   64  (23)   72  (19) 
[1] Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms.


  Outcome Measures
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1.  Primary:   Psychosocial Adjustment to Illness-Scale   [ Time Frame: baseline, 6 mo, 12mo ]

2.  Secondary:   Quality of Life   [ Time Frame: baseline, 6 mo, 12 mo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

A historical control group being the comparison group was the 'usual care' group that included participants who were enrolled during the study and received usual care, as described.

Lack of randomization may have been a confounding factor.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jacqueline de Leeuw MSc
Organization: Radboud University Nijmegen Medical Center
phone: +31243614925
e-mail: j.deleeuw@kno.umcn.nl


Publications of Results:

Responsible Party: Jacqueline de Leeuw, Radboud University
ClinicalTrials.gov Identifier: NCT01167179     History of Changes
Other Study ID Numbers: JDL-001-TVA
First Submitted: July 19, 2010
First Posted: July 22, 2010
Results First Submitted: December 6, 2012
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017