Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients

NCT ID: NCT05336318

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The present bicentric study has the aim to investigate the effectiveness of the peer supported mentoring program 'Peer2Me' with regard to psychosocial parameters using a prospective Comprehensive Cohort Design. Over a period of three months, acutely ill patients in the intervention group are accompanied by a mentor with the same disease and of similar age. Patients in the control group receive a one-time consultation. Before and after the intervention, mentors and mentees are interviewed about their psychosocial distress and quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After successful piloting of the mentoring program "Peer2Me", the mentoring program developed by us is now to be implemented and evaluated in a large-scale study in a second step, in order to be able to derive clinically relevant results.

A total of 180 acutely ill adolescent and young cancer patients (AYA) between the ages of 18 and 39 will be included in the study (intervention and control group). Again, young former cancer patients who have completed treatment will act as mentors and accompany acutely ill AYAs in the period after diagnosis for a period of three months. Prior to their assignment, the mentors take part in a training course, which includes the teaching of suitable conversation techniques, core topics in dealing with the cancer and advice on further care structures. Patients in the control group receive 30 minutes of standardized counseling regarding psychosocial care needs, including appropriate informational materials, during AYA consultation hours at both clinic sites. The study includes three measurement time points: t1: before the intervention; t2: after the end of the intervention; t3: 3 months after the end of the intervention. At all time points, participants will be surveyed using standardized questionnaires. With the help of these data and a comprehensive statistical analysis, the investigators want to make valid statements regarding the effects of peer mentoring on changes in psychological well-being as well as on social support and coping with illness.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Psychosocial Problem

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comprehensive cohort studies (CCS) are characterized by incorporating patient preferences into the study by using a "parallel preference group." The procedure is to ask patients' preferences at the beginning of the study before randomization. Those who do not consent to randomization will be retained in the study, but group assignment will be made according to their preferences. Patients who agree to randomization are randomized to one of the two groups (intervention vs. control).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Group Type EXPERIMENTAL

Peer support

Intervention Type BEHAVIORAL

patients were supported by a mentor

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peer support

patients were supported by a mentor

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cancer disease between the ages of 18 and 39 (all tumor entities)
* completion of acute treatment at least 2 years ago (mentors)
* curative prognosis
* Native language German or fluent German speaker
* first cancer diagnosis in the last 6 months (mentees, all tumor entities)
* curative prognosis

Exclusion Criteria

* existing and already diagnosed psychiatric disease, ongoing psychotherapy and/or existing suicidal tendency
* palliative treatment approach
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anja Mehnert

Prof. Anja Mehnert-Theuerkauf

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diana Richter, PhD.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Leipzig

Corinna Bergelt, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald, Institute for Medical Psychology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Leipzig

Leipzig, Saxony, Germany

Site Status RECRUITING

University Medical Center Hamburg-Eppendorf, Department of Medical Psychology

Hamburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diana Richter, PhD.

Role: CONTACT

+493419715438

Hannah Brock

Role: CONTACT

+493419718824

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anja Mehnert, PhD

Role: primary

Sarah Dwinger

Role: primary

+4940741056204

References

Explore related publications, articles, or registry entries linked to this study.

Brock H, Dwinger S, Friedrich M, Sender A, Geue K, Mehnert-Theuerkauf A, Bergelt C, Richter D. Peer2Me - impact of peer support on self-efficacy in young adult cancer survivors (YA-CS): findings from a comprehensive cohort design. BMC Cancer. 2025 May 26;25(1):943. doi: 10.1186/s12885-025-14323-5.

Reference Type DERIVED
PMID: 40420294 (View on PubMed)

Brock H, Dwinger S, Bergelt C, Sender A, Geue K, Mehnert-Theuerkauf A, Richter D. Peer2Me - evaluation of a peer supported program for adolescent and young adult (AYA) cancer patients: study protocol of a randomised trial using a comprehensive cohort design. BMC Cancer. 2024 Jul 2;24(1):788. doi: 10.1186/s12885-024-12547-5.

Reference Type DERIVED
PMID: 38956510 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DKH-70114047

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Psychosexual Educational Partners Program (PEPP)
NCT06253182 ACTIVE_NOT_RECRUITING NA