The Role of Caregiver in the Clinical Pathway of Patients Newly Diagnosed With Breast and Prostate Cancer: a Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Evaluation of the compliance with therapy
研究概览
简要总结
The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options.
详细描述
The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options. Moreover, a battery of self-report questionnaires will be administered, and sociodemographic and clinical data will be collected. The time window in which to deliver the support intervention is after the detection of a suspected cancer and before the visit with the oncologist, at the time when the patient undergoes diagnostic exams (to understand the type of tumor he/she is affected by), and the most suitable therapeutic protocol have to be discussed with the oncologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Patient aged ≥18 years at the time of recruitment.
- •Patients who have just received a cancer diagnosis and have yet to discuss with their oncologist the treatment to undergo after diagnosis of breast or prostate cancer.
- •Early-stage cancer (I or II).
- •Age ≥ 18 at the time of recruitment.
- •Taking care of the patient.
排除标准
- •Presence of early mental disorders (before age 40) or severe neurological disorder.
- •Patients with advanced stage cancer for which the path is already defined (palliative care patients).
- •Caregivers:
- •● Presence of early mental disorders (before age 40) or severe neurological disorder.
结局指标
主要结局
Evaluation of the compliance with therapy
时间窗: 6 months
The primary endpoint of this study is to observe a difference of 3 points in the average values of the "Interpersonal aspect of care" and "Subjective norm" subscales of the Adherence Determination Questionnaire (ADQ), in favor of the intervention group. Response options for each item formed a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 = strongly agree). The ADQ questionnaire contains 38 questions, with items 15 and 17 through 24 specifically phrased for patients who have cancer
次要结局
未报告次要终点