Clinical trial NCT05336318: Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients
Official title: Evaluation of a Peer Supported Program for Adolescent and Young Adult Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Psychosocial Problem
Keywords: adolescents and young adulthood
AYA
psychooncology
peer-support
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2022-04-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing post traumatic growth of mentors and change
timeFrame: Baseline and 3 months after intervention
measure: Assessing Empathy of mentors and change
timeFrame: Baseline and 3 months after intervention
measure: Life satisfaction of mentors and change
timeFrame: Baseline and 3 months after intervention
measure: Life satisfaction of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
measure: Self-efficacy of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
measure: Coping of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
measure: Anxiety of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
measure: Depressive symptoms of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
measure: Social support of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
measure: Health literacy of mentees and change
timeFrame: Baseline and 3 months after intervention and 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Medical Center Leipzig
state: Saxony
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Department of Medical Psychology
Study officials:
affiliation: Universitätsklinikum Leipzig
name: Diana Richter, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald, Institute for Medical Psychology
name: Corinna Bergelt, Prof.
role: PRINCIPAL_INVESTIGATOR
References: