Sexual Function, Coping and Dyadic Coping in Cervical Cancer Patients: a Comparison Between Surgery and Radiotherapy Plus Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Assess sexual function in cervical cancer patients
研究概览
简要总结
The studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. Moreover, a baseline evaluation about sexual function and coping if often lacking.
Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:
- To assess sexual function, coping, emotional distress, and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy.
- To evaluate changes on the previous variables over 6 months.
The results obtained will be utilized for:
- planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis
- develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients.
详细描述
Many recent reviews focused on QoL and the sexual function of patients with cervical cancer and have only evaluated the sexual dysfunctions of patients undergoing chemo-radiotherapy plus interventional radiotherapy.
The studies currently available in the literature are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. In fact, psychological factors caused by the cancer diagnosismay also negatively influence sexual functioning independently of the type of treatment or stage of cancer.
Common psychological issues included poor body image, decreased sense of femininity, anxiety about sexual interactions, and pain.
Consequently, related social issues may emerge, for example, the ability to maintain a sexual relationship, communication difficulties, and adverse effects on intimate relationships.
Women with cervical cancer have thus independently significant issues related to sexual functioning as a result of their disease and/or its treatment. The most important classification for cervical cancer is FIGO (International Federation Gynecology and Obstetrics) updated in 2021. Treatments for cervical cancer are different depending on this classification. Although early-stage cervical cancers have different prognosis and treatments with respect to invasive cervical cancers (surgery vs chemoradiation plus interventional radiotherapy), both types can have a major impact on patients' sexual function and coping, also dyadic coping since diagnosis.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients' age ≥ 18 years
- •Patients undergoing non-conservative surgery or radiotherapy plus chemotherapy
- •Patients able to understand and sign informed consent
排除标准
- •Patients' age > 65 years
- •Patients with inability to express informed consent
- •Patients denying informed consent
- •Patients with psychopathological disturbances preexisting to the cancer diagnosis
- •Patients affected by severe language deficits
结局指标
主要结局
Assess sexual function in cervical cancer patients
时间窗: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Primary outcome is to assess sexual function of cervical cancer patients undergoing surgery vs patients undergoing radiotherapy plus chemotherapy. This dimension will be assessed by "Female Sexual Function Index" (FSFI), a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The index only measures sexual function in these domains over the previous 30 days. The FSFI can be used as a screening tool and as a potential diagnostic aid. A total cut-off score ≤ 26.55 has been proposed for the diagnosis of female sexual dysfunction, so any woman scoring below 26.55 should be considered at risk for sexual dysfunction.
Assess individual coping strategies in cervical cancer patients
时间窗: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Assessment of individual coping strategies will be done in both groups by The Mini-Mental Adjustment to Cancer (Mini-MAC), a 29-item instrument that evaluates cognitive and behavioral responses to cancer. The factors of the Mini-MAC are: Fighting Spirit, Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Each item is rated on a 4-point scale that ranges from "definitely does not apply to me" to "definitely applies to me". Each statement is rated on a scale from 1 (definitely not) to 4 (definitely yes), and the available scores for each of the four coping strategies range from 7 to 28 points. The higher the score, the greater the coping/behavior style in the patient's fight against cancer.
次要结局
- Evaluate quality of life dimensions in cervical cancer patients(6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.)
- Evaluate dyadic coping in cervical cancer patients(6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.)
- Evaluate emotional Distress in cervical cancer patients(6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.)
- Evaluate Anxiety and Depression in cervical cancer patients(6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.)
- Evaluate the presence of any dissociative symtoms in cervical cancer patients(6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.)