CancerPeer2MeNCT05336318
Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients
A study testing Peer support in people with Cancer and Psychosocial Problem, run by University of Leipzig at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Psychosocial Problem
- What is being tested?
- Peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- existing and already diagnosed psychiatric disease, ongoing psychotherapy and/or existing suicidal tendency
- palliative treatment approach
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf, Department of Medical Psychology
Hamburg
Sarah Dwinger, +4940741056204, s.dwinger@uke.de
- Recruiting
University Medical Center Leipzig
Leipzig, Saxony, 04103
Anja Mehnert, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Psychosocial Problem
- Being tested
- Peer support
- Keywords
- adolescents and young adulthood, AYA, psychooncology, peer-support
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportBehavioural
patients were supported by a mentor
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Peer support |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after intervention and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
- Investigators
- Diana Richter, PhD., Principal investigator, Universitätsklinikum LeipzigCorinna Bergelt, Prof., Principal investigator, University Medicine Greifswald, Institute for Medical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336318
- Sponsor's protocol ID
- DKH-70114047
- Acronym
- Peer2Me
- Status last verified
- Aug 2024
- First submitted
- 4 Feb 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40420294Brock 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.
PubMed 38956510
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Peer Supported Program for Adolescent and Young Adult Cancer Patients
- ClinicalTrials.gov ID
- NCT05336318
- Acronym / sponsor ID
- Peer2Me / DKH-70114047
- Conditions
- Cancer, Psychosocial Problem
- Keywords
- adolescents and young adulthood, AYA, psychooncology, peer-support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Peer support |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- existing and already diagnosed psychiatric disease, ongoing psychotherapy and/or existing suicidal tendency
- palliative treatment approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer supportpatients were supported by a mentor | Behavioural | Intervention group |
Primary outcome
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.
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.
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").
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").
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 40420294Brock 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.
- Derived from this study: PubMed 38956510Brock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Richter, PhD. principal investigator
Universitätsklinikum Leipzig
Corinna Bergelt, Prof. principal investigator
University Medicine Greifswald, Institute for Medical Psychology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support in people with Cancer and Psychosocial Problem, run by University of Leipzig at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Richter, PhD. (+493419715438, diana.richter@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing post traumatic growth of mentors and change (time frame: Baseline and 3 months after intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.