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Trial Title: Feasibility of Technology-Based SSIP in Prostate Cancer Patients

NCT ID: NCT05720832

Condition: Prostate Cancer
Psychosocial Stressor

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
prostate cancer
social support
mental health
psychosocial intervention
pilot study

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: WINGS-IP1 Smartphone Application
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.
Arm group label: Prostate Cancer Patients and their Supporters

Other name: technology-based social-support intervention program

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.

Criteria for 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);

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Basel

Address:
City: Basel
Zip: 4031
Country: Switzerland

Start date: August 23, 2023

Completion date: June 30, 2025

Lead sponsor:
Agency: Wings Health AG
Agency class: Industry

Collaborator:
Agency: University Hospital, Basel, Switzerland
Agency class: Other

Source: Wings Health AG

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05720832

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