Trial Outcomes & Findings for Nurse-led Follow-up Care for Head and Neck Cancer Patients (NCT NCT01167179)

Last Updated: 2017-12-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

baseline, 6 mo, 12mo

Results posted on

2017-12-15

Participant Flow

Recruitment period: November 2007 to February 2010. Setting: outpatient oncology clinic

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	80	80
Overall Study COMPLETED	65	59
Overall Study NOT COMPLETED	15	21

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study disease recurrence	4	4
Overall Study Death	4	10
Overall Study Withdrawal by Subject	1	2
Overall Study diverse	6	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=80 Participants 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 n=80 Participants 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 n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants	69 Participants n=7 Participants	137 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 13.0 • n=5 Participants	59.2 years STANDARD_DEVIATION 12.3 • n=7 Participants	58.8 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	54 Participants n=7 Participants	114 Participants n=5 Participants
Region of Enrollment Netherlands	80 participants n=5 Participants	80 participants n=7 Participants	160 participants n=5 Participants
Psychosocial adjustment	46 units on a scale STANDARD_DEVIATION 12 • n=5 Participants	50 units on a scale STANDARD_DEVIATION 11 • n=7 Participants	49 units on a scale STANDARD_DEVIATION 12 • n=5 Participants
Quality of Life	76 units on a scale STANDARD_DEVIATION 17 • n=5 Participants	64 units on a scale STANDARD_DEVIATION 23 • n=7 Participants	72 units on a scale STANDARD_DEVIATION 19 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 mo, 12mo

Population: 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

Outcome measures

Outcome measures
Measure	Usual Care n=80 Participants 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 n=80 Participants 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.
Psychosocial Adjustment to Illness-Scale baseline	46 units on a scale Standard Deviation 12 • Interval 43.0 to 60.0	50 units on a scale Standard Deviation 11
Psychosocial Adjustment to Illness-Scale 6 mo	44 units on a scale Standard Deviation 12	44 units on a scale Standard Deviation 13
Psychosocial Adjustment to Illness-Scale 12 mo	42 units on a scale Standard Deviation 12	43 units on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: baseline, 6 mo, 12 mo

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

Outcome measures
Measure	Usual Care n=80 Participants 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 n=80 Participants 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.
Quality of Life baseline	76 units on a scale Standard Deviation 17	64 units on a scale Standard Deviation 23
Quality of Life 6 mo	80 units on a scale Standard Deviation 18	77 units on a scale Standard Deviation 16
Quality of Life 12 mo	80 units on a scale Standard Deviation 17	81 units on a scale Standard Deviation 18

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacqueline de Leeuw MSc

Radboud University Nijmegen Medical Center

Phone: +31243614925

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place