Feasibility of Technology-Based SSIP in Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

Technology-Based Social-Support Intervention Program for Reducing Psychosocial Burden in Prostate Cancer Patients: A Proof-of-Feasibility Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720832
• Other study ID #: 2022-02095
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Wings Health AG
• Contact: Noa Roemmel, M.Sc.
• Phone: +4161 556 53 25
• Email: noa.roemmel[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Stressor

Intervention

Other:
• WINGS-IP1 Smartphone Application
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (2)

Lead Sponsor	Collaborator
Wings Health AG	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	pre-intervention
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Other	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)
Other	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)
Other	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
Primary	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)
Secondary	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.	follow-up (after 12 weeks)
Secondary	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)
Secondary	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 a = 0.82 (Pressler et al., 2011).	pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Secondary	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 a = 0.88 (Staples et al., 2019).	pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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