An interventional study of Peer support in Cancer and Psychosocial Problem, sponsored by University of Leipzig. Recruiting at 2 sites in Germany. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by University of Leipzig · Not applicable, Interventional, and Supportive care
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.
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.
University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Peer support
patients were supported by a mentor
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.
Time frame: 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.
Time frame: 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").
Time frame: 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").
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months after intervention and 6 months after intervention
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Leipzig