Technology-Based Social-Support Intervention Program for Reducing Psychosocial Burden in Prostate Cancer Patients: A Proof-of-Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Subjective Usability
研究概览
简要总结
The goal of this pilot study is to assess the perceived usability of a smartphone application called WINGS targeting psychosocial distress and well-being in prostate cancer patients and their social network. The main questions it aims to answer are:
- How do prostate cancer patients and their social network rate the usability of the technology-based social-support intervention program smartphone application?
- Do symptoms of prostate cancer patients improve after using the WINGS smartphone application?
- Does the burden of prostate cancer patients social network decrease after using the WINGS smartphone application? Participants will be asked to use the WINGS smartphone application over the period of eight to twelve weeks and fill in questionnaires before, during, and after this time.
详细描述
There is still little knowledge about how smartphone apps can improve the quality of life in prostate cancer patients. Hence, the investigators are interested in finding out whether the simplified access to information and planning of activities increases the perceived social support in prostate cancer patients and ultimately improves their quality of life.
The duration of the study is approximately three months per participant. The WINGS smartphone application can be used from home and questionnaires can be completed online. Participants are therefore not required to be present at the University Hospital Basel during the entire course of the present study.
The investigators plan to recruit a total of 30 prostate cancer patients at the University Hospital Basel and 0-10 supporters (family members and friends) per prostate cancer patient. All study participants will have access to the regular treatment services of the University Hospital Basel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give written consent
- •≥ 18 years of age;
- •Sufficient knowledge of German language;
- •Confirmed diagnosis of prostate carcinoma;
- •Successfully completed prostatectomy with "Da Vinci®" method;
- •Willingness to use the WINGS-IP1 Smartphone Application (technology-based SSIP);
- •In possession of a smartphone on which the WINGS-IP1 Smartphone Application V1.0 can be installed (required operating systems: iOS 12.1 or newer, Android 7.0 or newer);
- •Access to the Internet with smartphone;
- •Ability to operate a smartphone;
排除标准
- •Previous enrolment in the current investigation;
- •Current diagnosis of severe mental disorder, namely bipolar disorder, schizophrenia, personality disorder;
- •Simultaneous participation in any other clinical trial, hospital program, or psychosocial intervention targeting similar concepts (e.g., mental wellbeing, social support, sexuality, etc.);
- •Receiving any current treatment for mental disorder (psychotherapy and/or medication) apart from already existing long-lasting therapies (≥ 6 months);
结局指标
主要结局
Subjective Usability
时间窗: post-intervention (after 8 weeks)
Primary outcome is prostate cancer patients' perceived usability of the WINGS-IP1 Smartphone Application measured by the German version of the 'Intervention Usability Scale' (IUS, \[Lyon et al., 2021\]). This scale was adapted from the 'System Usability Scale' (SUS, \[Brooke, 1996\]), a widely used self-reported scale to assess usability of digital systems, mobile applications, devices, and websites (see Kaya et al., 2019; Klug, 2017; Usability.gov, 2013). The SUS is composed of 10 items, assessed on a five-point Likert-scale, ranging from 0 = "strongly disagree" to 4 = "strongly agree" (Brooke, 1996). This scale will be completed by prostate cancer patients and their supporters.
次要结局
- Change in Depressive Symptoms(pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1))
- Change in Perceived Social Stigma(pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1))
- Treatment Expectancy and Rational Credibility(pre-intervention (T1))
- Change in Anxiety(pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1))
- Change in Mental Burden Related to Medical Condition(pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1))
- Subjective Usability Follow-up(follow-up (after 12 weeks))
- Daily Symptom Trajectories: Depressive Symptoms and Anxiety(daily assessment during 8 week intervention phase)
- Change in Perceived Social Support(pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1))
- Weekly Change in Perceived Social Support(weekly assessment during 8 week intervention phase)
- Change in Somatic Symptom Disorder(pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1))
- Hospital Record Data on Prostate Cancer Symptoms(six months post-prostatectomy)
- Change in Symptoms of Prostate Cancer(pre-intervention (T1), post-intervention (8 weeks after T1))