Head and Neck Cancer
Conditions
Keywords
head and neck cancer, nurse-led care, follow-up care, professional-patient relations, psychosocial adjustment, quasi-experimental, prospective, quality of life
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.
Interventions
BEHAVIORALnurse-led consultation
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.
Sponsors
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychosocial Adjustment to Illness-Scale | baseline, 6 mo, 12mo | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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. |
Countries
Netherlands
Participant flow
Recruitment details
Recruitment period: November 2007 to February 2010. Setting: outpatient oncology clinic
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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. | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 10 |
| Overall Study | disease recurrence | 4 | 4 |
| Overall Study | diverse | 6 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Usual Care | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 69 Participants | 137 Participants |
| Age, Continuous | 58.4 years STANDARD_DEVIATION 13 | 59.2 years STANDARD_DEVIATION 12.3 | 58.8 years STANDARD_DEVIATION 11.8 |
| Psychosocial adjustment | 46 units on a scale STANDARD_DEVIATION 12 | 50 units on a scale STANDARD_DEVIATION 11 | 49 units on a scale STANDARD_DEVIATION 12 |
| Quality of Life | 76 units on a scale STANDARD_DEVIATION 17 | 64 units on a scale STANDARD_DEVIATION 23 | 72 units on a scale STANDARD_DEVIATION 19 |
| Region of Enrollment Netherlands | 80 participants | 80 participants | 160 participants |
| Sex: Female, Male Female | 20 Participants | 26 Participants | 46 Participants |
| Sex: Female, Male Male | 60 Participants | 54 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Psychosocial Adjustment to Illness-Scale
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Psychosocial Adjustment to Illness-Scale | 12 mo | 42 units on a scale | Standard Deviation 12 |
| Usual Care | Psychosocial Adjustment to Illness-Scale | baseline | 46 units on a scale | Standard Deviation 12 |
| Usual Care | Psychosocial Adjustment to Illness-Scale | 6 mo | 44 units on a scale | Standard Deviation 12 |
| Intervention | Psychosocial Adjustment to Illness-Scale | baseline | 50 units on a scale | Standard Deviation 11 |
| Intervention | Psychosocial Adjustment to Illness-Scale | 6 mo | 44 units on a scale | Standard Deviation 13 |
| Intervention | Psychosocial Adjustment to Illness-Scale | 12 mo | 43 units on a scale | Standard Deviation 13 |
Secondary
Quality of Life
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.
Time frame: baseline, 6 mo, 12 mo
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Quality of Life | baseline | 76 units on a scale | Standard Deviation 17 |
| Usual Care | Quality of Life | 6 mo | 80 units on a scale | Standard Deviation 18 |
| Usual Care | Quality of Life | 12 mo | 80 units on a scale | Standard Deviation 17 |
| Intervention | Quality of Life | 12 mo | 81 units on a scale | Standard Deviation 18 |
| Intervention | Quality of Life | baseline | 64 units on a scale | Standard Deviation 23 |
| Intervention | Quality of Life | 6 mo | 77 units on a scale | Standard Deviation 16 |