Evaluation of Needs of Patients and Care-givers During and After Radiotherapy of Patients With Prostate Cancer

NCT ID: NCT07156903

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-11-30

Brief Summary

Exploratory qualitative survey to assess the needs of patients and their relatives during and after radiotherapy for prostate cancer and their attitudes and wishes regarding prehabilitation measures

Detailed Description

Across Germany, more than 500,000 people are newly diagnosed with cancer each year (Center for Cancer Registry Data, RKI, 2020). Prostate cancer, the most common cancer in men, affects more than 65,000 patients annually (https://www.krebsinformationsdienst.de/prostatakrebs). The gold standard for the treatment of advanced prostate cancer is radiotherapy combined with anti-hormonal therapy. If the cancer is detected earlier, surgery can be performed. Both procedures are then considered to be oncologically equivalent. Despite the most modern treatment methods and techniques, severe acute and long-term side effects still occur, which patients can experience as extremely limiting. These include, among other things, loss of libido and erectile function, the development of bladder weakness and even incontinence, and changes in bowel function (e.g., diarrhea).

Currently, patients often only begin treatments designed to mitigate these side effects during their rehabilitation, at least 4-6 weeks after therapy. However, the investigators believe that greater effects can be achieved and even the occurrence of serious side effects can be potentially prevented if treatment is initiated before or during therapy. This concept is called prehabilitation.

In order to develop a suitable prehabilitation program for prostate cancer patients undergoing curative radiation therapy (either definitive or postoperative), the investigators will conduct interviews with patients and, if possible, their immediate family members (e.g., partners) to learn more about their experiences before, during, and after the treatment. The investigators would also like to learn more about their attitudes and wishes regarding prehabilitation measures.

Conditions

Prostate Cancer Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

interviews

Patients will be asked to participate in interviews

Group Type: EXPERIMENTAL

Interview

Intervention Type: OTHER

Patients and their care-givers will be asked to participate in interviews

Interventions

Interview

Patients and their care-givers will be asked to participate in interviews

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed Prostate Cancer with curativ intended Radiotherapy
• min. 18 years
• sufficient knowledge of German language for participation in interviews
• Capacity to consent

Exclusion Criteria

• age <18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Franziska Hausmann

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Franziska Hausmann, MD

Role: CONTACT

franziska.hausmann@charite.de

+4930 450 557000

Facility Contacts

Franziska Hausmann, MD

Role: primary

franziska.hausmann@charite.de

+4930 450 557000

Other Identifiers

EA4/121/25

Identifier Type: -

Identifier Source: org_study_id