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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer Patients and their Supporters | Experimental | The WINGS smartphone application is being tested on prostate cancer patients for the first time in this pilot study. It provides easy access to prostate cancer-related information and simplifies networking with supporters, such as family and friends. The WINGS smartphone application can be easily downloaded to a personal smartphone via Google Play or the App Store and can be used at any time from home or on the go. In addition, the WINGS smartphone application also provides supporters, such as family members and friends of prostate cancer patients with easy access to prostate cancer-related information. Moreover, it helps them to support prostate cancer patients by facilitating joint activities, tailored to the needs of the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WINGS-IP1 Smartphone Application | Other | The technology-based SSIP ("WINGS") offers disease-related information and builds up social inner circles between patients, their friends, and family members while facilitating to organize, perform, and enjoy activities and content. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Usability | 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. | post-intervention (after 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Usability Follow-up | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Internet Self-Efficacy Scale | In order to measure patients' beliefs in their capabilities to use the German version of the Internet and Internet-based programs the investigators will use the 'Internet Self-efficacy Scale' (ISS, [Eastin & LaRose, 2006]). The ISS is a self-report measure, including 10 items rated on a seven-point Likert-scale ranging from 1 = "strongly disagree" to 7 = "strongly agree". For the purpose of this study, the investigators will translate the ISS into German. This scale will be completed by prostate cancer patients and their supporters. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunther Meinlschmidt, Prof. Dr. | University Hospital Basel, Basel Switzerland | Principal Investigator |
| Rainer Schaefert, Prof. Dr. | University Hospital Basel, Basel Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25697335 | Background | Miller SM, Hudson SV, Hui SK, Diefenbach MA, Fleisher L, Raivitch S, Belton T, Roy G, Njoku A, Scarpato J, Viterbo R, Buyyounouski M, Denlinger C, Miyamoto C, Reese A, Baman J. Development and preliminary testing of PROGRESS: a Web-based education program for prostate cancer survivors transitioning from active treatment. J Cancer Surviv. 2015 Sep;9(3):541-53. doi: 10.1007/s11764-015-0431-5. Epub 2015 Feb 20. | |
| 11857323 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| follow-up (after 12 weeks) |
| Change in Mental Burden Related to Medical Condition | In order to assess change mental burden related to medical condition the investigators will use the German version of the 'Mental Health Component Summary Score' of the 'Short Form-36 Version 1'(SF-36, [Ware, 2000]). The SF-36 is a validated, self-report instrument consisting of 36 items rated on five-choice response scales. The possible score ranges from 0 to 100 points, whereby 0 points represent the greatest possible health restriction and 100 points represent no health restriction at all. This scale will only be completed by prostate cancer patients. | pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1) |
| Change in Depressive Symptoms | The investigators will use the German version of the 'Patient Health Questionnaire' with 8 items (PHQ-8) to assess the severity of depressive symptoms in prostate cancer patients (Kroenke et al., 2009; Kroenke & Spitzer, 2002). The last criteria had been excluded as it assesses suicidal or self-injurious thoughts, which investigators will not be able to address adequately within the context of the proposed study. Prostate cancer patients and their supporters will be asked to indicate how often they experienced a depressive symptom in the past two weeks (Kroenke et al., 2009). They rate these symptoms on a four-point Likert-scale ranging from 0 = "not at all," 1 = "several days," 2 = "more than half the days," to 3 = "nearly every day". The PHQ-8 demonstrated acceptable internal consistency with Cronbach's α = 0.82 (Pressler et al., 2011). | pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1) |
| Change in Anxiety | The investigators will implement the German version of the seven item 'General Anxiety Disorder Scale' (GAD-7) to assess the presence of generalized anxiety disorder, social phobia, panic disorder, and post-traumatic stress disorder (Spitzer et al., 2006; Staples et al., 2019). Prostate cancer patients and their supporters rate items on a four-point Likert-scale ranging from 0 = "not at all," 1 = "several days," 2 = "more than half the days," to 3 = "nearly every day", based on their symptoms in the last two weeks. The GAD-7 showed acceptable discriminative validity (AUCs between 0.74 and 0.75, ps < 0.001) and good test-retest reliability (r = 0.83) and internal consistency with Cronbach's α = 0.88 (Staples et al., 2019). | pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1) |
| Daily Symptom Trajectories: Depressive Symptoms and Anxiety | In order to measure daily fluctuations of depressive symptoms and anxiety during the eight-week intervention phase, the investigators will implement the 'Patient Health Questionnaire' (PHQ-4) which consists of the PHQ-2 (Kroenke et al., 2003) and the 'General Anxiety Disorder Scale' (GAD-2, [Staples et al., 2019]) as Ecological Momentary Assessment (EMA, [Stone et al., 1999]). Both measures will be adapted in accordance with procedures of Bauer and colleagues (2018) to adjust instructions and Likert-scales to daily assessments. This scale will only be completed by prostate cancer patients. | daily assessment during 8 week intervention phase |
| Change in Perceived Social Stigma | In the proposed study the investigators will assess prostate cancer patients perceived stigma using the German version of the 'Social Impact Scale' (SIS-D) with 24 items (Fife & Wright, 2000). The SIS-D has been previously used to measure stigma in cancer patients and covers four dimensions, namely social rejection, internalised shame, social isolation, and financial insecurity. All items are answered on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). This scale will only be completed by prostate cancer patients. | pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1) |
| Change in Perceived Social Support | To assess prostate cancer patients' perceived social support, the investigators will use the German version of the 'Oslo Social Support Scale' (OSSS-3, [Dalgard et al., 2006; Kocalevent et al., 2018]). The OSSS-3 is a very brief, three-item scale. In addition to pre- and post-intervention assessment, the investigators will also measure the OSSS-3 weekly, to assess fluctuations in perceived social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support. This scale will only be completed by prostate cancer patients. | pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1) |
| Weekly Change in Perceived Social Support | To assess prostate cancer patients' perceived social support, the investigators will use the German version of the 'Oslo Social Support Scale' (OSSS-3, [Dalgard et al., 2006; Kocalevent et al., 2018]). The OSSS-3 is a very brief, three-item scale. In addition to pre- and post-intervention assessment, the investigators will also measure the OSSS-3 weekly, to assess fluctuations in perceived social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support. This scale will only be completed by prostate cancer patients. | weekly assessment during 8 week intervention phase |
| Change in Somatic Symptom Disorder | The investigators will assess somatic symptom disorder using the 'Somatic Symptom Disorder-B Criteria Scale' (SSD-12) composed of 12 items (Toussaint et al., 2016). These subscales are divided into three psychological subscales including cognitive aspects, affective aspects, and behavioural aspects. All items are answered on a 5-point Likert scale from 1 ("never") to 4 ("very often"). This scale will only be completed by prostate cancer patients. | pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1) |
| Change in Symptoms of Prostate Cancer | The investigators will assess symptoms associated with prostate cancer and its treatment with the German version of the 'Expanded Prostate Cancer Index Composite' (EPIC-26, [Wei et al., 2000]). The EPIC-26 is a self-reported measure to assess patient function and distress after prostate cancer treatment. It covers multiple health-related quality of life (HRQOL) domains, namely urinary (incontinence and irritative/obstructive), bowel, sexual, and hormonal functionality. Each of these domains are assessed in terms of their function and bother and summarized into domain summary scores. The higher the EPIC-26 score (maximum 100 points), the better the patient's assessment of functionality in the dimension covered. This scale will only be completed by prostate cancer patients. | pre-intervention (T1), post-intervention (8 weeks after T1) |
| Treatment Expectancy and Rational Credibility | In order to assess prostate cancer patients' expectancy and the perceived credibility of the WINGS-IP1 Smartphone Application the investigators will use the 'Credibility Expectancy Questionnaire' (CEQ, [Devilly & Borkovec, 2000]). A total of six items are rated on a 1-9 or a 0%-100% scale, depending upon the item. Higher scores refer to higher expectancy and higher credibility. This scale will only be completed by prostate cancer patients. | pre-intervention (T1) |
| Hospital Record Data on Prostate Cancer Symptoms | In addition, the 'Expanded Prostate Cancer Index Composite' (EPIC-26, [Wei et al., 2000]) will be assessed in prostate cancer patients six months post-prostatectomy as part of the clinical standard procedures at the University Hospital Basel. Hence, instead of a follow-up assessment 12 weeks after T1, the investigators will retrieve prostate cancer patients' EPIC-26 data from hospital records entered during the standard six months post-prostatectomy follow-up. | six months post-prostatectomy |
| pre-intervention |
| Reported Use Frequency Post-Intervention | The investigators will ask patients and their supporters to declare how often they have used the WINGS Smartphone Application during the eight-week intervention phase (e.g., daily, every other day, three times a week, twice a week, once a week, less than once a week). | post-intervention (after 8 weeks) |
| Reported Use Frequency Follow-up | The investigators will ask patients and their supporters to declare how often they have used the WINGS Smartphone Application during the eight-week intervention phase (e.g., daily, every other day, three times a week, twice a week, once a week, less than once a week). | follow-up (after 12 weeks) |
| Reported Number of Supporters Contacted by Patients Post-Intervention | The investigators will ask patients to declare how many supporters they have contacted via WINGS Smartphone Application. | post-intervention (after 8 weeks) |
| Reported Number of Supporters Contacted by Patients Follow-up | The investigators will ask patients to declare how many supporters they have contacted via WINGS Smartphone Application. | follow-up (after 12 weeks) |
| Number of Supporters per Patient Post-Intervention in WINGS Smartphone Application | The investigators will extract the number of supporters per individual patient directly from the WINGS Smartphone Application. | post-intervention (after 8 weeks) |
| Number of Supporters per Patient Follow-up WINGS Smartphone Application | The investigators will extract the number of supporters per individual patient directly from the WINGS Smartphone Application. | follow-up (after 12 weeks) |
| Reported Psycho-Oncological Consultation Uptake Post-Intervention | The investigators will ask prostate cancer patients if they had taken up psycho-oncological consultation before or after their prostatectomy. | post-intervention (after 8 weeks) |
| Psycho-Oncological Consultation Uptake Post-Intervention in Hospital Records | The investigators will consult hospital records to check whether patients have had any psycho-oncological consultations. | post-intervention (after 8 weeks) |
| Reported Psycho-Oncological Consultation Uptake Follow-up | The investigators will ask prostate cancer patients if they had taken up psycho-oncological consultation before or after their prostatectomy. | follow-up (after 12 weeks) |
| Psycho-Oncological Consultation Uptake Follow-up in Hospital Records | The investigators will consult hospital records to check whether patients have had any psycho-oncological consultations. | follow-up (after 12 weeks) |
| Report of Adverse Event (AE) and/or Device Deficiency (DD) | The investigators will ask prostate cancer patients and their supporters to report any Adverse Events (AEs) in free text format. | through study completion, an average of 3 months |
| Report of Device Deficiency (DD) | The investigators will ask prostate cancer patients and their supporters to report any Device Deficiencies (DDs) in free text format. | through study completion, an average of 3 months |
| General Feedback Post-Intervention | The investigators will ask prostate cancer patients and their supporters to provide general feedback on the WINGS Smartphone Application. | post-intervention (after 8 weeks) |
| General Feedback Follow-up | The investigators will ask prostate cancer patients and their supporters to provide general feedback on the WINGS Smartphone Application. | follow-up (after 12 weeks) |
| Adverse Event (AE) and/or Device Deficiency (DD) Assessed by Investigators | The investigators will adequately assess any undesired side effects of the intervention and document the rate of adverse events in general, considering reports of adverse events or device deficiency by prostate cancer patients and supporters. The investigators will also monitor (severe) Adverse Events (AEs) relating to participants' disease progression, including (but not limited to) death and hospitalization. AEs will be designated and managed according to ICH-GCP E6 (International Conference on Harmonization (ICH), 2016). All AEs that occur during the study will be monitored. | through study completion, an average of 3 months |
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| 16572275 | Background | Dalgard OS, Dowrick C, Lehtinen V, Vazquez-Barquero JL, Casey P, Wilkinson G, Ayuso-Mateos JL, Page H, Dunn G; ODIN Group. Negative life events, social support and gender difference in depression: a multinational community survey with data from the ODIN study. Soc Psychiatry Psychiatr Epidemiol. 2006 Jun;41(6):444-51. doi: 10.1007/s00127-006-0051-5. Epub 2006 Mar 29. |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |