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Feasibility of Technology-Based SSIP in Prostate Cancer Patients

Primary Purpose

Prostate Cancer, Psychosocial Stressor

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
WINGS-IP1 Smartphone Application
Sponsored by
Wings Health AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, social support, mental health, psychosocial intervention, pilot study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to give written consent Male; ≥ 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; Exclusion Criteria: 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);

Sites / Locations

  • University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate Cancer Patients and their Supporters

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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.
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.
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 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.
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.
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.
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.
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.

Full Information

First Posted
January 16, 2023
Last Updated
August 23, 2023
Sponsor
Wings Health AG
Collaborators
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT05720832
Brief Title
Feasibility of Technology-Based SSIP in Prostate Cancer Patients
Official Title
Technology-Based Social-Support Intervention Program for Reducing Psychosocial Burden in Prostate Cancer Patients: A Proof-of-Feasibility Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wings Health AG
Collaborators
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Psychosocial Stressor
Keywords
prostate cancer, social support, mental health, psychosocial intervention, pilot study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate Cancer Patients and their Supporters
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
WINGS-IP1 Smartphone Application
Other Intervention Name(s)
technology-based social-support intervention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective Usability
Description
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.
Time Frame
post-intervention (after 8 weeks)
Secondary Outcome Measure Information:
Title
Subjective Usability Follow-up
Description
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.
Time Frame
follow-up (after 12 weeks)
Title
Change in Mental Burden Related to Medical Condition
Description
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.
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Title
Change in Depressive Symptoms
Description
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).
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Title
Change in Anxiety
Description
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).
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Title
Daily Symptom Trajectories: Depressive Symptoms and Anxiety
Description
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.
Time Frame
daily assessment during 8 week intervention phase
Title
Change in Perceived Social Stigma
Description
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.
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Title
Change in Perceived Social Support
Description
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.
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Title
Weekly Change in Perceived Social Support
Description
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.
Time Frame
weekly assessment during 8 week intervention phase
Title
Change in Somatic Symptom Disorder
Description
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.
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Title
Change in Symptoms of Prostate Cancer
Description
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.
Time Frame
pre-intervention (T1), post-intervention (8 weeks after T1)
Title
Treatment Expectancy and Rational Credibility
Description
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.
Time Frame
pre-intervention (T1)
Title
Hospital Record Data on Prostate Cancer Symptoms
Description
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.
Time Frame
six months post-prostatectomy
Other Pre-specified Outcome Measures:
Title
Internet Self-Efficacy Scale
Description
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.
Time Frame
pre-intervention
Title
Reported Use Frequency Post-Intervention
Description
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).
Time Frame
post-intervention (after 8 weeks)
Title
Reported Use Frequency Follow-up
Description
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).
Time Frame
follow-up (after 12 weeks)
Title
Reported Number of Supporters Contacted by Patients Post-Intervention
Description
The investigators will ask patients to declare how many supporters they have contacted via WINGS Smartphone Application.
Time Frame
post-intervention (after 8 weeks)
Title
Reported Number of Supporters Contacted by Patients Follow-up
Description
The investigators will ask patients to declare how many supporters they have contacted via WINGS Smartphone Application.
Time Frame
follow-up (after 12 weeks)
Title
Number of Supporters per Patient Post-Intervention in WINGS Smartphone Application
Description
The investigators will extract the number of supporters per individual patient directly from the WINGS Smartphone Application.
Time Frame
post-intervention (after 8 weeks)
Title
Number of Supporters per Patient Follow-up WINGS Smartphone Application
Description
The investigators will extract the number of supporters per individual patient directly from the WINGS Smartphone Application.
Time Frame
follow-up (after 12 weeks)
Title
Reported Psycho-Oncological Consultation Uptake Post-Intervention
Description
The investigators will ask prostate cancer patients if they had taken up psycho-oncological consultation before or after their prostatectomy.
Time Frame
post-intervention (after 8 weeks)
Title
Psycho-Oncological Consultation Uptake Post-Intervention in Hospital Records
Description
The investigators will consult hospital records to check whether patients have had any psycho-oncological consultations.
Time Frame
post-intervention (after 8 weeks)
Title
Reported Psycho-Oncological Consultation Uptake Follow-up
Description
The investigators will ask prostate cancer patients if they had taken up psycho-oncological consultation before or after their prostatectomy.
Time Frame
follow-up (after 12 weeks)
Title
Psycho-Oncological Consultation Uptake Follow-up in Hospital Records
Description
The investigators will consult hospital records to check whether patients have had any psycho-oncological consultations.
Time Frame
follow-up (after 12 weeks)
Title
Report of Adverse Event (AE) and/or Device Deficiency (DD)
Description
The investigators will ask prostate cancer patients and their supporters to report any Adverse Events (AEs) in free text format.
Time Frame
through study completion, an average of 3 months
Title
Report of Device Deficiency (DD)
Description
The investigators will ask prostate cancer patients and their supporters to report any Device Deficiencies (DDs) in free text format.
Time Frame
through study completion, an average of 3 months
Title
General Feedback Post-Intervention
Description
The investigators will ask prostate cancer patients and their supporters to provide general feedback on the WINGS Smartphone Application.
Time Frame
post-intervention (after 8 weeks)
Title
General Feedback Follow-up
Description
The investigators will ask prostate cancer patients and their supporters to provide general feedback on the WINGS Smartphone Application.
Time Frame
follow-up (after 12 weeks)
Title
Adverse Event (AE) and/or Device Deficiency (DD) Assessed by Investigators
Description
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.
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to give written consent Male; ≥ 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; Exclusion Criteria: 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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noa Roemmel, M.Sc.
Phone
+4161 556 53 25
Email
noa.roemmel@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunther Meinlschmidt, Prof. Dr.
Organizational Affiliation
University Hospital Basel, Basel Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rainer Schaefert, Prof. Dr.
Organizational Affiliation
University Hospital Basel, Basel Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noa Roemmel, MSc.
Phone
+41615565325
Email
noa.roemmel@usb.ch
First Name & Middle Initial & Last Name & Degree
Gunther Meinlschmidt, Prof. Dr.
Email
gunther.meinlschmidt@usb.ch
First Name & Middle Initial & Last Name & Degree
Gunther Meinlschmidt, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Noa Roemmel, MSc.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25697335
Citation
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.
Results Reference
background
PubMed Identifier
11857323
Citation
Bacon CG, Giovannucci E, Testa M, Glass TA, Kawachi I. The association of treatment-related symptoms with quality-of-life outcomes for localized prostate carcinoma patients. Cancer. 2002 Feb 1;94(3):862-71. doi: 10.1002/cncr.10248.
Results Reference
background
PubMed Identifier
23045995
Citation
Badger TA, Segrin C, Figueredo AJ, Harrington J, Sheppard K, Passalacqua S, Pasvogel A, Bishop M. Who benefits from a psychosocial counselling versus educational intervention to improve psychological quality of life in prostate cancer survivors? Psychol Health. 2013;28(3):336-54. doi: 10.1080/08870446.2012.731058. Epub 2012 Oct 9.
Results Reference
background
PubMed Identifier
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