Feasibility of Technology-Based SSIP in Prostate Cancer Patients

NCT05720832 | Active Not Recruiting

• 1 other identifier: 2022-02095
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Psychosocial Stressor

Keywords

prostate cancer; social support; mental health; psychosocial intervention; pilot study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Subjective Usability Follow-up

  follow-up (after 12 weeks)

• Change in Mental Burden Related to Medical Condition

  pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)

• Change in Depressive Symptoms

  pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)

• Change in Anxiety

  pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)

• Daily Symptom Trajectories: Depressive Symptoms and Anxiety

  daily assessment during 8 week intervention phase

Other Outcomes (16)

• Internet Self-Efficacy Scale

  pre-intervention

• Reported Use Frequency Post-Intervention

  post-intervention (after 8 weeks)

• Reported Use Frequency Follow-up

  follow-up (after 12 weeks)

Study Arms (1)

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.

Other: WINGS-IP1 Smartphone Application

Interventions

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.

Also known as: technology-based social-support intervention program

Prostate Cancer Patients and their Supporters

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Wings Health AG: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

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MeSH Terms

Conditions

Prostatic Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior

Study Officials

• Gunther Meinlschmidt, Prof. Dr.

  University Hospital Basel, Basel Switzerland

  PRINCIPAL INVESTIGATOR

• Rainer Schaefert, Prof. Dr.

  University Hospital Basel, Basel Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 9, 2023
• Study Start: August 23, 2023
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)