Peer Support Program in cáncer Patients Elkar Laguntza
Phase: NA
Conditions: Neoplasms, Social Skills, Psychological Distress
Sponsor: Joana Perez Tejada

  
 
Date 2020, 01/09 
STUDY PROTOCOL. Elkar laguntza 
AIMS 
The general aim of the present research will be to evaluate the effectiveness of a peer social 
support intervention in cancer patients at the Onkologikoa Foundation of Guipuzcoa. 
Specifically, the immediate and long-term effect that such intervention will have on symptoms 
of psychological distress, quality of life, coping strategy, perception of social support, perception 
of the disease and emotional regulation will be evaluated. As a secondary aim of this study, we 
intend to evaluate the immediate and long-term effect of the peer social support intervention 
on the immune system (through the determination of the levels of cytokines IL-1β, IL-2, IL-6, IL-
8, IL-10, IFN-γ and TNF-α), on the monoaminergic system (through the determination of plasma 
levels of serotonin, tyrosine, phenylalanine, tryptophan, quinurenine, quinurenic acid and 3-HK), 
on the HPA axis (through the measurement of the diurnal cycle of cortisol), and on sex hormones 
(through the measurement of estradiol and testosterone levels), systems that have been related 
both to the development of anxious-depressive symptoms and to the development, progression 
and recurrence of cancer.  
In addition, it will be studied at what time the application of the program is most effective, being 
applied in newly diagnosed patients (experimental group 1) and in patients who have just 
finished medical treatment (experimental group 2).  
METHODS 
The present project will consist of a longitudinal clinical trial to evaluate the effectiveness of a 
peer social support intervention in cancer patients at the Onkologikoa Foundation of Guipuzcoa.  
The intervention will consist of 8 face-to-face peer social support sessions conducted by 
volunteers diagnosed with various types of cancer who have finished their medical treatment 
(chemotherapy, radiotherapy, surgery) or who have been in a stable phase for at least two years 
and who are motivated to participate in this type of intervention. These people will initially be 
informed through informative meetings or through letters sent by e-mail by professionals from 
the Onkologikoa Foundation and the Osakidetza Active Patient program and, afterwards, they 
will be referred to the program coordinator Joana Pérez Tejada for a series of evaluations with 
the aim of checking whether these people have an adequate physical and mental recovery and 
that participation in the program will have the minimum psychological impact on them. Thus, 
the medical history will be checked and the following psychological variables will be evaluated: 
personality (through the Big-5 Inventory Short Version questionnaire), coping style (through the 
COPE-28 questionnaire), presence of anxious-depressive symptoms (through the Hospitalary 
Anxiety and Depression Scale questionnaire), resilience (through the resilience questionnaire) 
and emotional regulation (through the Emotion Regulation Questionnaire).      
The selected individuals will participate in a training program conducted by experts in the field, 
including psychologists, physicians and oncologists, in which lectures, group work and role 
playing will be conducted under the supervision of the researchers. The main topics covered 

  
 
Date 2020, 01/09 
during the program will include: cancer diagnosis and treatment, management and prevention 
of side effects, healthy habits, emotional intelligence, empathy and communication skills, 
among others. All volunteers will be informed of the importance of confidentiality of patient 
information. 
Each of the volunteers will have to be with 2 or 3 patients at the same time since some authors 
state that performing support to more than one patient can compensate for a poor relationship 
with another patient, as well as serve as support in the event of a patient's death (Moulton et 
al., 2013). The volunteer-patient sessions will be conducted in rooms set up for this purpose in 
the Carlos Santamaría building of the UPV/EHU. After each session with the patients, each 
volunteer will have to attend an individual session with the program coordinator Joana Pérez 
Tejada to discuss their emotions and reactions after performing the intervention. Psychological 
supervision of the volunteers is a fundamental part of avoiding retraumatization and the 
possible appearance of anxious-depressive symptoms (Giese-Davis et al., 2006). Likewise, 
volunteers will have to participate in group sessions every two months with the rest of the 
volunteers and the program coordinator Joana Pérez Tejada in order to strengthen group 
cohesion, resolve doubts, detect needs and carry out the necessary training.  
The patients in this study will be 120 patients with various types of cancer from the Onkologikoa 
Foundation. Each patient will be matched with a volunteer depending on the type of tumor and 
medical treatment, since some authors state that for the support program to be effective, the 
volunteers must have had the same type of tumor and medical treatment as the patients 
(Pistrang et al., 2012). This is why it will be necessary to homogenize the group of volunteers as 
much as possible so that the sample of patients has as little variability as possible. The inclusion 
criteria are: having received the diagnosis of cancer in the last month; not having started medical 
treatment; the tumor type and medical treatment coinciding with any of the volunteers. The 
exclusion criteria are: relapse; suffering or having suffered from a serious mental disorder 
(according to DSM-V criteria). The recruitment of these patients will take place just after the 
diagnosis, and the professionals of the Onkologikoa Foundation will be in charge of offering this 
type of intervention to the patients who meet the inclusion criteria of the study.  
Those patients who are interested in participating will be informed about the present research 
project by the coordinator of the program and by the members of the research team of the 
Onkologikoa Foundation and it will be these same people who will be in charge of giving the 
information sheet and the informed consent, and of summoning each participant for the 
collection of data for the first evaluation. Each participant will be given an evaluation 
questionnaire of sociodemographic, clinical and psychological variables that he/she will have to 
bring completed for the day of the appointment. Also, each participant will be given four saliva 
collection bottles, which they will have to collect four times the day before their appointment. 
The times of collection of these saliva samples will be upon waking up, 30 minutes later, before 
lunch (between 13:00 and 13:30) and before dinner (between 20:00 and 20:30). The saliva 
samples will be collected by the program coordinator at the Onkologikoa Foundation and will 
be coded and managed by the Biobanko. Subsequently, they will be taken to the Psychobiology 
laboratory of the UPV/EHU for the determination of different biological variables. In addition, 

  
 
Date 2020, 01/09 
participants will have to undergo a blood draw on the day of the appointment. The blood 
collection will be performed by a nurse member of the research team of the Onkologikoa 
Foundation. The blood samples will be coded and managed by the Biobanko. Subsequently, they 
will be transferred to the Psychobiology laboratory of the UPV/EHU for the determination of 
different biological variables.  
After this first collection of clinical, psychological and biological data, patients will be randomly 
selected, through a balanced block randomization method, to be part of the experimental group 
1 (EG1) or the experimental group (EG2). As this is a crossover design clinical trial, patients in 
GE1 will start the peer social support program before the start of medical treatment, while 
patients in GE2 will start the peer social support program after the end of medical treatment.  
For each GE1 patient, a specific volunteer will be selected based on the patient's tumor type and 
medical treatment, although depending on the availability of volunteers, other variables will also 
be taken into account: age, preferred language, time availability, partner, children and 
socioeconomic level. Once selected, each patient and volunteer will be given a letter of 
introduction to the other, in order to learn basic information about the patient before the first 
session. The social peer support program will begin the week prior to the start of medical 
treatment. There will be a total of eight sessions, one every fifteen days approximately, for a 
total duration of four months. The duration of each session will be as follows: the first and 
second sessions will last approximately one hour, the following sessions will last an average of 
30 minutes. Patients and volunteers will be given the possibility to request a change of person 
in case they feel that the bond between them is not adequate.  
Once the support program has been completed in EG1, a second evaluation of clinical, 
psychological and biological variables will be carried out, and, in addition, satisfaction with the 
intervention program will be evaluated, thanks to the Treatment Satisfaction Questionnaire. In 
GE2, the evaluation of clinical, psychological and biological variables will be carried out four 
months after the first evaluation. A third evaluation of all participants will be carried out 15 days 
after receiving the news of the end of the medical treatment (chemotherapy or radiotherapy). 
At four months and eight months after the end of medical treatment (chemotherapy or 
radiotherapy), the fourth and fifth evaluations will be carried out. In each of these evaluations 
the procedure will be as follows: each participant will be given a questionnaire of psychological 
measures to fill in before their appointment and four saliva collection tubes, which they will 
have to collect the day before their appointment. In addition, they will be scheduled for a blood 
draw and for the collection of the questionnaires and saliva samples. 
GE2 patients will participate in the peer support program, but the application of this intervention 
will take place 15 days after receiving the news of the end of medical treatment. The 
intervention in this group will have the same characteristics and the same evaluations as those 
of GE1. 
VARIABLES 

  
 
Date 2020, 01/09 
The sociodemographic and clinical variables to be collected are: age, marital status, employment 
status, language, family situation, clinical history of interest, personal and family history of 
psychopathology, pharmacological, psychological and substance use treatment, tumor type, 
stage and medical treatment. 
The psychological variables will be assessed by means of the following questionnaires: Big-5 brief 
personality questionnaire, HADS anxiety and depression questionnaire, COPE-28 coping 
questionnaire, brief illness perception questionnaire, MOS-SSS social support questionnaire, SF-
12 quality of life questionnaire, resilience scale, ERQ emotional regulation scale and the program 
satisfaction questionnaire. 
The biological variables to be determined are:  
- In blood: levels of cytokines related to tumor development and inflammation (IL1β, IL-2, IL-6, 
IL-8, IL-10, IFN-γ and TNF-α); monoaminergic activity (tyrosine, phenylalanine, tryptophan, 
quinurenine, serotonin, quinurenic acid and 3HK) and IDO activity (through the tyrosine-
kinurenine ratio). 
- In saliva: the diurnal cortisol cycle and estrogen and testosterone levels.  
 
DATA ANALYSIS 
The relationships between the variables collected will be analyzed with the SPSS version 22.0 
statistical package and with the JMP 10 statistical package. In all the analyses performed, the 
following variables will be controlled: type and duration of medical treatment and 
pharmacological treatment. Repeated measures analyses will be performed to study the effect 
of the intrasubject support program. Also, in order to study the possible physiological and 
psychological differences between experimental groups 1 and 2, analysis of variance (ANOVA) 
will be carried out. Pearson's correlation coefficient will be used to analyze the relationships 
between the different physiological and psychological variables considered in this study. Several 
General Linear Models (GLM) analyses will be performed to determine the predictive value of 
each of the variables in the possible benefit obtained after the application of the program. To 
study the interactions in each of the GLM analyses performed, a simple regression analysis will 
be carried out.