Individualized Follow-Up for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Acceptability - assessed by the SUS
研究概览
简要总结
This pilot study evaluates offering Head and Neck Cancer (HNC) patients a choice between standardized and individualized follow-up after HNC treatment. Following treatment, the patient will be educated about self-examination of the head and neck and which physical symptoms require a follow-up visit. After completing 1.5 years of uncomplicated guideline-prescribed follow-up, patients will be offered the option to switch to individualized follow-up through a tailored decision aid. Standardized follow-up entails continuing the guideline-prescribed follow-up schedule until five years after treatment. Individualized follow-up consists of follow-up visits based on symptoms and other needs at the patient's initiative. We hypothesize that giving patients the choice between standardized and individualized follow-up is feasible and saves costs while maintaining quality of life.
详细描述
Background of the study:
Head and Neck Cancer (HNC) patients are currently enrolled in routine follow-up by medical specialists (standardized follow-up) for five years after primary treatment, according to the Dutch guideline Head and Neck Tumors. Similar recommendations are described in guidelines from the US and UK. The purposes for aftercare following cancer treatment as stated by the Health Council of the Netherlands are to address the effects of the disease and treatment itself, to detect new cancer manifestations, and to evaluate medical procedures to improve the quality of care.
The majority of HNC recurrences occur in the first 1.5-two years after treatment, and most of them cause clinical symptoms.It has not been proven that patients with recurrent disease discovered in the asymptomatic phase have better treatment options and life expectancy than patients who experience symptoms at the time of discovery.
Detecting second primary tumors (SPT) is an extra argument for routine follow-up as HNC patients are at greater risk of developing second primary cancers. SPTs are known to negatively affect overall long-term survival, especially those found outside the head and neck area. However, the way in which control visits are performed, namely physical examination of the head and neck, does not aim to identify SPTs elsewhere in the body. Because the incidence of SPTs remains stable over the years after treatment, detecting them would require life-long follow-up through diagnostic imaging.
Many patients express the concern that their cancer will progress or recur after treatment, also known as fear of cancer recurrence (FCR). FCR has a major impact on quality of life. It is not clear whether routine control visits exacerbate or relieve FCR, although previous research suggests that patient-led follow-up, in which prescheduled visits are replaced by patient-education and access to care by self-referral, does not influence FCR. Furthermore, patients have reported being anxious before scheduled control visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant tumor of the head and neck
- •First primary HNC
- •Participant was treated with curative intent
- •Participant has completed one year of uncomplicated routine follow-up
- •Treating physician supports the possible choice for patient-led follow-up
排除标准
- •Malignant tumors of salivary glands
- •Participant is cognitively impaired
- •Participant is unable to read or write in Dutch
结局指标
主要结局
Acceptability - assessed by the SUS
时间窗: Baseline
The use of the decision-aid will be evaluated using the System Usability Scale (SUS): 10 items giving a global view of subjective assessments of usability of the decision-aid on a 5-point scale from strongly disagree (1) to strongly agree (5). A higher score means higher usability. 10 self-constructed questions about the presentation, actual use, and perceived added value are added to the questionnaire.
Follow-up decision
时间窗: Baseline
The type of follow-up that was chosen (standardized or individualized) will be distracted from the electronical patient record.
Demand - assessed by the reach
时间窗: 1.5 years
Number of patients who received the decision-aid and the choice for follow-up in our clinical practice divided by the number of patients eligible to use the decision-aid and thus make a choice between the two follow-up programs.
Tailored decision aid - usability
时间窗: Baseline
The use of a tailored decision aid to support the decision making process will be evaluated using the System Usability Scale (SUS): 10 items giving a global view of subjective assessments of usability of the decision-aid on a 5-point scale from strongly disagree (1) to strongly agree (5).
Tailored decision aid - implementation in clinical practice
时间窗: 1.5 years
The use of a tailored decision aid from a physician perspective will be evaluated by an adjusted version of the MIDI questionnaire to measure determinants associated with successful implementation of the decision aid. In general, a higher score means higher (expected) use in clinical practice.
Tailored decision aid - use and added value
时间窗: Baseline
The use of a tailored decision aid to support the decision making process will be evaluated by a self-constructed questionnaire consisting of 10 additional questions about the presentation, actual use, and the perceived added value of the decision aid from a patient perspective. A higher score means higher usability.
次要结局
- Quality of life - Fear of cancer recurrence(1.5 years)
- Quality of life - EORTC QLQ C-30(Baseline)
- Practicality - outpatients visits and tests(1.5 years)
- Quality of life - EQ-5D-5L(1.5 years)
- Practicality Medical consumption(1.5 years)
- Quality of life - EORTC QLQ-H&N35(Baseline)
- Quality of life - QLQ C-30(1.5 years)
- Shared decision making for patients(Baseline (after decision making consult))
- Shared decision making for physicians(Baseline (after decision making consult))
- Decisional conflict(Baseline)
- Practicality - Medical consumption(Baseline)
- Decisional regret(1.5 years)
- Practicality - Productivity loss(1.5 years)
- Quality of life - QLQ-H&N35(1.5 years)