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

NCT05336318 | Recruiting

• 1 other identifier: DKH-70114047
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer; Psychosocial Problem

Keywords

adolescents and young adulthood; AYA; psychooncology; peer-support

Outcome Measures

Primary Outcomes (10)

• Assessing post traumatic growth of mentors and change

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: Peer support

Control group

NO INTERVENTION

Interventions

Peer support BEHAVIORAL

patients were supported by a mentor

Intervention group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• existing and already diagnosed psychiatric disease, ongoing psychotherapy and/or existing suicidal tendency
• palliative treatment approach

Sponsors & Collaborators

• University of Leipzig: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (2)

University Medical Center Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf, Department of Medical Psychology

Hamburg, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 40420294 DERIVED

• 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.

  PMID: 38956510 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Diana Richter, PhD.

  Universitätsklinikum Leipzig

  PRINCIPAL INVESTIGATOR

• Corinna Bergelt, Prof.

  University Medicine Greifswald, Institute for Medical Psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Richter, PhD.

CONTACT

+493419715438; diana.richter@medizin.uni-leipzig.de

Hannah Brock

CONTACT

+493419718824; hannah.brock@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Anja Mehnert-Theuerkauf

Model Details: 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).

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: April 20, 2022
• Study Start: January 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

DE (2)