Evaluation of an Electronic Psycho-oncological Adaptive Screening Program to Assess Psychological Burden and Need for Psycho-social Support Among Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 660
- 主要终点
- Information level about psychosocial services at 3 months-follow-up
研究概览
简要总结
Background: Psychological burden in cancer patients may worsen quality of life and even medical outcomes such as mortality. Nevertheless, many distressed patients are not recognized by the treating clinicians and left untreated even though effective psychosocial interventions exist. Existing screenings programs have multiple limitations such as the necessity of time consuming training and involvement of clincial staff, conventional screening instruments with limited diagnostic accuracy and the focusing on objective measures of distress, thereby neglecting subjective supportive care needs.
Aims: To address some of the limitations outlined above, we developed an electronic psycho-oncological adaptive screening program (EPAS) which separately assesses distress and psychosocial care needs and provides immediate patient feedback with individualized recommendations about psychosocial care services.
Design: Patients of the intervention are compared to a control condition. All participants are assessed at three measurement points (baseline, and at 3-months and 6-months follow-up).
Outcomes: Outcomes assess aspects related to psychosocial care services, well-being and satisfaction.
Recruitment: Patients are recruited within suitable health care facilities within the University Cancer Center Hamburg (UCCH) and other facilities in the competence network of the UCCH. Patients are checked for eligibility via review of the medical chart and consecutively recruited by research assistants.
Duration of the study: From start of recruitment, 2 years are planned until data analysis. 1 year is planned for recruitment.
Analyses: We conduct group comparisons in the study outcomes, both unconditional and condcitional (controlled for care relevant co-variates).
详细描述
Background: Psychological burden in cancer patients may worsen quality of life and even medical outcomes such as mortality. Nevertheless, many distressed patients are not recognized by the treating clinicians and left untreated even though effective psychosocial interventions exist. Existing screenings in turn have multiple limitations: To be effective in reducing distress, screening results need to be adequately interpreted and transformed into individualized support plans. Most of current screening programs expect the clinical staff to undertake this task, which in turn requires extensive and repeated training. Another critical issue is the assessment: To limit the completion time to a minimum, conventional screening instruments contain as few items as possible, which in turn limits their diagnostic accuracy. Finally, most screening programs assume that there is a clear link between reported levels of distress and the individual need for psychosocial care. Accordingly, many current screenings derive the need for psychosocial care exclusively from the level of distress reported by the patients. However, self-reported distress and self-reported supportive care need are not closely related.
Aims of the study: To address some of the limitations outlined above, we developed an electronic psycho-oncological adaptive screening program (EPAS) which separately assesses distress and psychosocial care needs and provides immediate patient feedback with individualized recommendations about psychosocial care services.
Design: Patients of the intervention are compared to a control condition. All participants are assessed at three measurement points (baseline, and at 3-months and 6-months follow-up).
Outcomes: Outcomes assess aspects related to psychosocial care services, well-being and satisfaction.
Sample size: Our study aims to separately test for group differences (screening vs. no screening) at t1 and t2. To detect an expected small to medium group difference in level of information (effect size = 0.3) with a power of 80 %, sample sizes of 176 patients in each group were needed. Given an expected drop-out rate of 30 % from t0 to t2, we initially planned to recruit n = 251 per group (ntotal = 502).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •minimum age of 18 years
- •diagnosed with any malignancy according to ICD-10 (first diagnosis or relapse)
排除标准
- •Patients with any impairments interfering with the ability to give informed consent
结局指标
主要结局
Information level about psychosocial services at 3 months-follow-up
时间窗: The outcome is assessed at T1 (3-months follow-up).
On 10 items, patients rate their level of information for each of the 10 available psychosocial services on a scale from 0 to 4, with higher values indicating a higher level of information. Items are evaluated as single scales.
Information level about psychosocial services at 6 months-follow-up
时间窗: The outcome is assessed at T2 (six months follow-up).
On 10 items, patients rate their level of information for each of the 10 available psychosocial services on a scale from 0 to 4, with higher values indicating a higher level of information. Items are evaluated as single scales.
Use of the psychosocial services at 3-months follow-up
时间窗: The outcome is assessed at T1 (3-months follow-up).
On an internally developed questionnaire, patients rate on 10 binary items (yes/no) whether they have used each of the 10 psychosocial services available at the study center. The items are analysed as single scales.
Use of the psychosocial services at 6-months follow-up
时间窗: The outcome is assessed at T2 (six months follow-up).
On an internally developed questionnaire, patients rate on 10 binary items (yes/no) whether they have used each of the 10 psychosocial services available at the study center. The items are analysed as single scales.
Evaluation of access to psychosocial services
时间窗: The outcome is assessed at T1 (3-months follow-up).
On 4 nominal items (yes/no/do not know), we assess whether any i) communication with the physicians about supportive/complementary care needs, ii) recommendations by the physicians for psychosocial services, iii) concrete offers by the physicians to use a psychosocial service or iv) request by the physicians for a consultation service have taken place.
Depressive symptomatology at 3-months follow-up
时间窗: The outcome is assessed at T1 (3-months follow-up).
PHQ-9: On 9 items, patients rate the frequency of depressive symptoms on a scale from 0 to 3, with higher scores indicating a higher symptomatology (range of sum score: 0 - 27).
Depressive symptomatology at 6-months follow-up
时间窗: The outcome is assessed at T2 (six months follow-up).
PHQ-9: On 9 items, patients rate the frequency of depressive symptoms on a scale from 0 to 3, with higher scores indicating a higher symptomatology (range of sum score: 0 - 27).
Anxious symptomatology at 3-months follow-up
时间窗: The outcome is assessed at T1 (3-months follow-up).
GAD-7: On 7 items, patients rate the frequency of anxious symptoms on a scale from 0 to 3, with higher values indicating higher level of anxiety (range of sum score: 0 - 21).
Anxious symptomatology at 6-months follow-up
时间窗: The outcome is assessed at T2 (6-months follow-up).
GAD-7: On 7 items, patients rate the frequency of anxious symptoms on a scale from 0 to 3, with higher values indicating higher level of anxiety (range of sum score: 0 - 21).
Health-related quality of life at 3-months follow-up
时间窗: The outcome is assessed at T1 (3-months follow-up).
SF-8: On 8 items, patients rate their impairments of health-related quality of life across different areas on items ranging from 0 to 5/6. Items are later transformed on a scale from 0 to 100, with higher values indicating a higher level of quality of life.
Health-related quality of life at 6-months follow-up
时间窗: The outcome is assessed at T2 (6-months follow-up).
SF-8: On 8 items, patients rate their impairments of health-related quality of life across different areas on items ranging from 0 to 5/6. Items are later transformed on a scale from 0 to 100, with higher values indicating a higher level of quality of life.
Treatment satisfaction at 3-months follow-up
时间窗: The outcome is assessed at T1 (3-months follow-up).
On 32 items, patients rate their satisfaction with medical and psychosocial cancer care on a scale ranging from 1 to 5/6, with higher scores indicating higher level of satisfaction. The questionnaire is analysed by sum scores across specific subscales (Competence, Information, Access, Support, Overall medical treatment, Overall psychosocial treatment).
Treatment satisfaction at 6-months follow-up
时间窗: The outcome is assessed at T2 (6-months follow-up).
On 32 items, patients rate their satisfaction with medical and psychosocial cancer care on a scale ranging from 1 to 5/6, with higher scores indicating higher level of satisfaction. The questionnaire is analysed by sum scores across specific subscales (Competence, Information, Access, Support, Overall medical treatment, Overall psychosocial treatment).
次要结局
未报告次要终点
研究者
Anja Mehnert
Prof. Dr. Anja Mehnert-Theuerkauf
University of Leipzig