Feasibility of Technology-Based SSIP in Prostate Cancer Patients
NCT ID: NCT05720832
Last Updated: 2024-08-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
27 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-08-23
Study Completion Date
2025-06-30
Brief Summary
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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:
* 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.
* 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.
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Detailed Description
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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.
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.
Conditions
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Prostate Cancer
Psychosocial Stressor
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Prostate Cancer Patients and their Supporters
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.
Group Type
EXPERIMENTAL
WINGS-IP1 Smartphone Application
Intervention Type
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.
Interventions
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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.
Intervention Type
OTHER
Other Intervention Names
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technology-based social-support intervention program
Eligibility Criteria
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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;
* 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);
* 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);
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Sponsor Role
collaborator
Wings Health AG
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gunther Meinlschmidt, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Basel Switzerland
Rainer Schaefert, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Basel Switzerland
Locations
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University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Site Status
Countries
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Switzerland
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Other Identifiers
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2022-02095
Identifier Type: -
Identifier Source: org_study_id
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