## Protocol Section
### Identification Module
**NCT ID:** NCT01167179

**Brief Title:** Nurse-led Follow-up Care for Head and Neck Cancer Patients

**Official Title:** Nurse-led Follow-up Care for Head and Neck Cancer Patients: a Quasi-experimental Study

#### Organization Study ID Info
**ID:** JDL-001-TVA
#### Organization
**Class:** OTHER
**Full Name:** Radboud University Medical Center
### Status Module
#### Completion Date
**Date:** 2012-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-12-15

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-12-15

**Type:** ACTUAL

**Results First Submit Date:** 2012-12-06

**Results First Submit QC Date:** 2017-05-16

#### Start Date
**Date:** 2008-12

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2010-07-22
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-19
**Study First Submit QC Date:** 2010-07-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Radboud University Medical Center

#### Responsible Party

**Investigator Affiliation:** Radboud University Medical Center

**Investigator Full Name:** Jacqueline de Leeuw

**Investigator Title:** MSc

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.

**Detailed Description:** Background: After treatment for cancer, follow-up surveillance is regarded important. In head and neck cancer patients however, increasing research evidence shows that at least the goal of detecting recurrence of cancer during routine control visits in an asymptomatic stage is not achieved. Other goals of follow-up such as management of treatment complications and helping patients and families cope and adjust remain important and ask for an accurate, effective but tailored and sensitive approach. Increasingly, nurses are mentioned as care providers best suited to perform this task.

Aim: The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.

Methods and design: A quasi-experimental prospective design is used. Two groups of patients are enrolled consecutively (n=160) and patient data are collected at baseline (T0), at 6(T1) and at 12(T2) months respectively. The duration of the intervention is defined to the first year of follow up. Participating nurses are trained prior to the recruitment of the intervention group and receive supervision and individual coaching during the entire duration of the intervention phase.

Outcome measures: Primary outcome, psychosocial adjustment to illness. Secondary outcomes, health related quality of life, psychosocial problems, and usage of care.

### Conditions Module

**Conditions:**

- Head and Neck Cancer

**Keywords:**

- head and neck cancer

- nurse-led care

- follow-up care

- professional-patient relations

- psychosocial adjustment

- quasi-experimental

- prospective

- quality of life

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 160

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Usual care Participants in the comparison group receive the usual care which consists of a 5 year medical routine control schedule based on the national guidelines, and - if appropriate - involvement of the dietician and the speech language therapist.During years one to five the routine control appointments are planned at a minimum of every 2, 3, 4, 6 and 12 months respectively. Most patients who undergo a total laryngectomy have additional contact with an oncology nurse during their 6-8 weekly medical control visits at the outpatient clinic for approximately the first year of follow-up. All other head and neck cancer patients have no structured follow-up contact with an oncology nurse.

**Label:** comparison group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Interventional care Year 1 follow-up: 2-monthly medical control visit + 30 minute nursing consultation, to a minimum of 6 in year 1. No restrictions with regard to cancer stage, site or treatment modality.

Intervention consist of standardised nursing consultations comprising a thorough needs assessment, supportive counseling, adequate referral to other care providers if necessary and improvement of the continuity of follow-up care. Goals: helping patients (and their partners) cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship.

**Intervention Names:**

- Behavioral: nurse-led consultation

**Label:** nurse-led consultation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- nurse-led consultation

**Description:** Content of the intervention The intervention consists of structured and standardised nursing follow up consultations comprising a thorough needs assessment, supportive counseling, adequate referral to other care providers if necessary and improvement of the continuity of follow-up care. The goals of nursing follow-up care are summarised as helping patients (and often their partners too) to cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship.

**Name:** nurse-led consultation

**Other Names:**

- nurse-led follow-up care

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation.

**Measure:** Psychosocial Adjustment to Illness-Scale

**Time Frame:** baseline, 6 mo, 12mo

#### Secondary Outcomes

**Description:** 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.

**Measure:** Quality of Life

**Time Frame:** baseline, 6 mo, 12 mo

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosed with a primary head and neck tumour
* Absence of other cancers diagnosed
* Treatment with curative intent, all treatment modalities
* Treatment and 12 month follow-up planned in Radboud University Nijmegen Medical Centre
* Able to speak, write and understand Dutch
* Cognitively able to give informed consent

Exclusion Criteria:

* Actual psychiatric disease
* Actual alcohol addiction
* Known life expectancy of \< 6 months

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nijmegen

**Country:** Netherlands

**Facility:** Radboud University Nijmegen Medical Centre

**Zip:** 6500 HB

#### Overall Officials

**Official 1:**

**Affiliation:** Radboud University Medical Center

**Name:** T van Achterberg, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** de Leeuw J, Prins JB, Teerenstra S, Merkx MA, Marres HA, van Achterberg T. Nurse-led follow-up care for head and neck cancer patients: a quasi-experimental prospective trial. Support Care Cancer. 2013 Feb;21(2):537-47. doi: 10.1007/s00520-012-1553-1. Epub 2012 Aug 4.

**PMID:** 22864472

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Head and Neck Cancer

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006258

- Term: Head and Neck Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Usual Care

**Description:** 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.

**ID:** EG000

**Other Num at Risk:** 80

**Serious Number At Risk:** 80

**Title:** Usual Care

**Group ID:** EG001

**Title:** Intervention

**Description:** 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.

**ID:** EG001

**Other Num at Risk:** 80

**Serious Number At Risk:** 80

**Title:** Intervention

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 80

**Group ID:** BG001

**Value:** 80

**Group ID:** BG002

**Value:** 160

**Units:** Participants

### Group

**ID:** BG000

**Title:** Usual Care

**Description:** 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.

### Group

**ID:** BG001

**Title:** Intervention

**Description:** 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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 68

#### Measurement

**Group ID:** BG001

**Value:** 69

#### Measurement

**Group ID:** BG002

**Value:** 137

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 23

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.0

**Value:** 58.4

#### Measurement

**Group ID:** BG001

**Spread:** 12.3

**Value:** 59.2

#### Measurement

**Group ID:** BG002

**Spread:** 11.8

**Value:** 58.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 46

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 60

#### Measurement

**Group ID:** BG001

**Value:** 54

#### Measurement

**Group ID:** BG002

**Value:** 114

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 80

#### Measurement

**Group ID:** BG001

**Value:** 80

#### Measurement

**Group ID:** BG002

**Value:** 160

**Class Title:** Netherlands

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12

**Value:** 46

#### Measurement

**Group ID:** BG001

**Spread:** 11

**Value:** 50

#### Measurement

**Group ID:** BG002

**Spread:** 12

**Value:** 49

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 17

**Value:** 76

#### Measurement

**Group ID:** BG001

**Spread:** 23

**Value:** 64

#### Measurement

**Group ID:** BG002

**Spread:** 19

**Value:** 72

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** 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).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Psychosocial adjustment
**Unit of Measure:** units on a scale
### Measure 6
**Description:** 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.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Quality of Life
**Unit of Measure:** units on a scale
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Limitations and Caveats
**Description:** 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.
### Point of Contact
**Email:** j.deleeuw@kno.umcn.nl
**Organization:** Radboud University Nijmegen Medical Center
**Phone:** +31243614925
**Title:** Jacqueline de Leeuw MSc
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17
- **Upper Limit:** 
- **Value:** 76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23
- **Upper Limit:** 
- **Value:** 64
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16
- **Upper Limit:** 
- **Value:** 77
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18
- **Upper Limit:** 
- **Value:** 81
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 43
- **Spread:** 12
- **Upper Limit:** 60
- **Value:** 46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11
- **Upper Limit:** 
- **Value:** 50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** 44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12
- **Upper Limit:** 
- **Value:** 42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** 43
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted
**Reporting Status:** POSTED
**Time Frame:** baseline, 6 mo, 12 mo
**Title:** Quality of Life
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Usual Care
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Intervention
#### Outcome Measure 2
**Description:** The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted
**Reporting Status:** POSTED
**Time Frame:** baseline, 6 mo, 12mo
**Title:** Psychosocial Adjustment to Illness-Scale
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Usual Care
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Intervention
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Usual Care
#### Group
**Description:** 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.
**ID:** FG001
**Title:** Intervention
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** disease recurrence
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 10
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** diverse
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 80
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 80
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 65
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 59
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
**Pre-Assignment Details:** 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.
**Recruitment Details:** Recruitment period: November 2007 to February 2010. Setting: outpatient oncology clinic
**Has Results:** True