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

Cancer Clinical Trial

— Peer2Me  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336318
• Other study ID #: DKH-70114047
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University of Leipzig
• Contact: Diana Richter, PhD.
• Phone: +493419715438
• Email: diana.richter[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 190 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: September 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Psychosocial Problem

Intervention

Behavioral:
• Peer support
patients were supported by a mentor

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf, Department of Medical Psychology	Hamburg
Germany	University Medical Center Leipzig	Leipzig	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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