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

August 22, 2024 updated by: Anja Mehnert, University of Leipzig

Evaluation of a Peer Supported Program for Adolescent and Young Adult Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • University Medical Center Hamburg-Eppendorf, Department of Medical Psychology
        • Contact:
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • University Medical Center Leipzig
        • Contact:
          • Anja Mehnert, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
Behavioral: Peer support
patients were supported by a mentor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing post traumatic growth of mentors and change
Time Frame: Baseline and 3 months after intervention
The Posttraumatic Growth Inventory (PTGI) measures the extent to which patients have experienced positive changes regarding cancer. The questionnaire contains 21 items in the five dimensions: new opportunities, relationship with others, personal strength, appreciation of life, and spiritual change. Using a three-point Likert scale, patients indicate the extent to which the item responses apply. Item scores are summed to form a total score, with higher scores indicating higher posttraumatic growth.
Baseline and 3 months after intervention
Assessing Empathy of mentors and change
Time Frame: Baseline and 3 months after intervention

The Saarbrücken Personality Questionnaire on Empathy is the German adaptation of the Interpersonal Reactivity Index. The SPF is a questionnaire for self-assessment of one's own empathic abilities and consists of 16 items that measure both the cognitive and the emotional dimension of empathy on four subscales: imagination, empathic distress, empathic sympathy, and perspective taking.

A five-point Likert scale (1- never to 5- always) is used to assess the extent to which the statements are true.
Baseline and 3 months after intervention
Life satisfaction of mentors and change
Time Frame: Baseline and 3 months after intervention
The FLZ-M is a valid instrument that measures the subjective assessment of satisfaction in various areas of life. Life satisfaction is assessed using the two modules "general life satisfaction" and "satisfaction with health", each with eight items and one overall item. Subjective satisfaction and importance are assessed on a five-point Likert scale (0 = "dissatisfied" to 4 = "very satisfied").
Baseline and 3 months after intervention
Life satisfaction of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention
The FLZ-M is a valid instrument that measures the subjective assessment of satisfaction in various areas of life. Life satisfaction is assessed using the two modules "general life satisfaction" and "satisfaction with health", each with eight items and one overall item. Subjective satisfaction and importance are assessed on a five-point Likert scale (0 = "dissatisfied" to 4 = "very satisfied").
Baseline and 3 months after intervention and 6 months after intervention
Self-efficacy of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention

The General Self-Efficacy Expectancy Scale is a self-assessment procedure with 10 items for assessing general optimistic self-convictions. It measures the expectation of subjective competence to cope with difficult situations such as cancer.

A four-point Likert scale is used to ascertain the extent to which patients agree with the statements. The individual test score is calculated by summing up all ten items.
Baseline and 3 months after intervention and 6 months after intervention
Coping of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention
Self-efficacy in coping with cancer can be defined as the confidence of a cancer patient in his or her ability to develop adaptive coping behavior. The German version of the short form of the Cancer Behavior Inventory (CBI-B-D) uses 14 items to describe coping behavior in the context of cancer. Patients estimate on a nine-point Likert scale how confident they are in performing certain behaviors. By summing all 14 item scores, a sum score is obtained, with high scores indicating high confidence in the ability to perform the coping behavior.
Baseline and 3 months after intervention and 6 months after intervention
Anxiety of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention
The Generalized Anxiety Scale measures symptoms of generalized anxiety disorders and the symptom severity of generalized anxiety on a four-point Likert scale using seven items. The individual item scores are summed to a total score, which can assume values between 0 and 21 points.
Baseline and 3 months after intervention and 6 months after intervention
Depressive symptoms of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention
The Patient Health Questionnaire measures depressive symptoms on a four-point Likert scale using nine items. The PHQ-9 can be evaluated both categorically and by summing up the item characteristics. The scale sum value can reach values between 1 and 27.
Baseline and 3 months after intervention and 6 months after intervention
Social support of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention
The Berlin Social Support Scales measure six dimensions of social support in a multidimensional approach: perceived social support, received social support, provided social support, need and search for social support, and protective cushioning in the sense of protecting others from stress.
Baseline and 3 months after intervention and 6 months after intervention
Health literacy of mentees and change
Time Frame: Baseline and 3 months after intervention and 6 months after intervention
The HLS-EU-Q16 measures health literacy with 16 items and was developed from the long version of the HLS-EU-Q47. The items refer to various tasks and activities related to health care, disease prevention or health promotion. Respondents rate in each case how easy they think the corresponding task or activity is ("very easy," "fairly easy," "fairly difficult," "very difficult"). A sum score from 0 to 16 can be calculated, and the latter can be classified as insufficient (<9), problematic (9-12), and sufficient (13-16) health literacy.
Baseline and 3 months after intervention and 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Diana Richter, PhD., Universitätsklinikum Leipzig
  • Principal Investigator: Corinna Bergelt, Prof., University Medicine Greifswald, Institute for Medical Psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DKH-70114047

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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