Clinical trial NCT05720832: Feasibility of Technology-Based SSIP in Prostate Cancer Patients
Official title: Technology-Based Social-Support Intervention Program for Reducing Psychosocial Burden in Prostate Cancer Patients: A Proof-of-Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Psychosocial Stressor
Keywords: prostate cancer
social support
mental health
psychosocial intervention
pilot study
Lead sponsor: Wings Health AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2023-02-09
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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);

Primary outcomes:
measure: Subjective Usability
timeFrame: post-intervention (after 8 weeks)
Secondary outcomes:
measure: Subjective Usability Follow-up
timeFrame: follow-up (after 12 weeks)
measure: Change in Mental Burden Related to Medical Condition
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
measure: Change in Depressive Symptoms
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
measure: Change in Anxiety
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
measure: Daily Symptom Trajectories: Depressive Symptoms and Anxiety
timeFrame: daily assessment during 8 week intervention phase
measure: Change in Perceived Social Stigma
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
measure: Change in Perceived Social Support
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
measure: Weekly Change in Perceived Social Support
timeFrame: weekly assessment during 8 week intervention phase
measure: Change in Somatic Symptom Disorder
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1), follow-up (12 weeks after T1)
measure: Change in Symptoms of Prostate Cancer
timeFrame: pre-intervention (T1), post-intervention (8 weeks after T1)
measure: Treatment Expectancy and Rational Credibility
timeFrame: pre-intervention (T1)
measure: Hospital Record Data on Prostate Cancer Symptoms
timeFrame: six months post-prostatectomy
Other outcomes:
measure: Internet Self-Efficacy Scale
timeFrame: pre-intervention
measure: Reported Use Frequency Post-Intervention
timeFrame: post-intervention (after 8 weeks)
measure: Reported Use Frequency Follow-up
timeFrame: follow-up (after 12 weeks)
measure: Reported Number of Supporters Contacted by Patients Post-Intervention
timeFrame: post-intervention (after 8 weeks)
measure: Reported Number of Supporters Contacted by Patients Follow-up
timeFrame: follow-up (after 12 weeks)
measure: Number of Supporters per Patient Post-Intervention in WINGS Smartphone Application
timeFrame: post-intervention (after 8 weeks)
measure: Number of Supporters per Patient Follow-up WINGS Smartphone Application
timeFrame: follow-up (after 12 weeks)
measure: Reported Psycho-Oncological Consultation Uptake Post-Intervention
timeFrame: post-intervention (after 8 weeks)
measure: Psycho-Oncological Consultation Uptake Post-Intervention in Hospital Records
timeFrame: post-intervention (after 8 weeks)
measure: Reported Psycho-Oncological Consultation Uptake Follow-up
timeFrame: follow-up (after 12 weeks)
measure: Psycho-Oncological Consultation Uptake Follow-up in Hospital Records
timeFrame: follow-up (after 12 weeks)
measure: Report of Adverse Event (AE) and/or Device Deficiency (DD)
timeFrame: through study completion, an average of 3 months
measure: Report of Device Deficiency (DD)
timeFrame: through study completion, an average of 3 months
measure: General Feedback Post-Intervention
timeFrame: post-intervention (after 8 weeks)
measure: General Feedback Follow-up
timeFrame: follow-up (after 12 weeks)
measure: Adverse Event (AE) and/or Device Deficiency (DD) Assessed by Investigators
timeFrame: through study completion, an average of 3 months
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital Basel, Basel Switzerland
name: Gunther Meinlschmidt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Basel, Basel Switzerland
name: Rainer Schaefert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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