Implementation and evaluation of mobile health tools for personalised follow-up of patients in radiation therapy for prostate cancer

Recruiting

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00023818
• Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

SUBSTUDY 1:
Prostate cancer patients under radiation with curative intent,
histologically proven PCA,
cT1-3,
cN0, cM0,
Gleason Score 6-9,
PSA <40 ng/ml.

SUBSTUDY 2:
Patients with primary prostate cancer of favorable-intermediate- to very-high risk after NCCN (National Comprehensive Cancer Network)
histologically proven PCA,
cT2a-3b (MRT, PET/CT),
cN0 und cM0 (MRT, PET/CT),
Gleason-Score 7-9,
ECOG Performance Status 0 or 1,
IPSS < 15,
size of prostate = 75 ml (as of date of radiation therapy planning)

Exclusion Criteria

SUBSTUDIES 1 and 2: insufficient command of German language, patient too much distressed by his condition, acute psychosis, risk of suicide present.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' expectations regarding the functions of the intended app allowing them to record their therapy-related preferences (rating-scales developed by ourselves), distress (distress thermometer) and health-related quality of life before and during radiation therapy and at follow-up (EORTC QLQ-C30, EPIC-26, IPSS25).

Secondary Outcome Measures

Name	Time	Method
Quality of life in the ensuing course of radiation therapy (EORTC QLQ-C30, EPIC-26, IPSS25) and subjective ratings of difficulty with weighing therapy-related preferences with respect to outcomes and possible side effects (rating-scales developed by ourselves).