Shared Care Follow-up After Chemotherapy for Testicular Cancer

NCT01783145 | Active Not Recruiting

• 2 other identifiers: SCFU-TC 1.201138710
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Conditions

Testicular Cancer

Keywords

survivorship care; testicular cancer; shared care model

Outcome Measures

Primary Outcomes (2)

• Safety of a shared care survivorship care plan (SCP).

  The aim of this study is to develop and evaluate a shared care SCP to follow-up patients with disseminated TC after completion of chemotherapy. Participants in the SCP will be patients, GPs and oncologists. The SCP will be defined according to follow-up guidelines for TC patients, with a focus on disease relapse and late effects.

  Monitoring of safety will be done on a continuous basis with average duration of two years per participant.

• Feasibility of a shared care survivorship care plan (SCP).

  The aim of this study is to develop and evaluate a shared care SCP to follow-up patients with disseminated TC after completion of chemotherapy. Participants in the SCP will be patients, GPs and oncologists. The SCP will be defined according to follow-up guidelines for TC patients, with a focus on disease relapse and late effects.

  Monitoring of feasibility will be done on a continuous basis with average duration of two years per participant.

Secondary Outcomes (2)

• Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists.

  Up to two years.

• Willingness to migrate from hospital care to primary care.

  Up to two years.

Study Arms (1)

Patients

Patients with disseminated TC who have finished their chemotherapy, if needed followed by surgery, and who are in complete remission and currently in active follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with disseminated TC who have finished their chemotherapy, if needed followed by surgery, and who are in complete remission and currently in active follow-up.

You may qualify if:

• Patients with disseminated testicular cancer;
• Complete remission after chemotherapy with or without adjunctive surgery and in active follow-up;
• Age 18 years or older;
• Started with chemotherapy after January 1st 2003;
• Written informed consent.

You may not qualify if:

• Mental disability

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• J.A. Gietema, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 4, 2013
• Study Start: October 1, 2012
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

NL (1)