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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