Peer Support Program in Cancer Patients Elkar Laguntza

Neoplasms Clinical Trial

— ElkarLaguntz  

Official title:

Peer Support Program in cáncer Patients Elkar Laguntza

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077371
• Other study ID #: PI2018068
• Secondary ID: 2019
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Onkologikoa
• Contact: Joana Perez Tejada
• Phone: 943328140
• Email: jperez[@]onkologikoa.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In cancer patients, social support provided by partners, family and/or friends plays a key role in coping with the disease and reducing treatment-related distress. However, research indicates that some of the needs of patients, such as coping with the disease, reducing isolation or managing guilt, often go unmet. With the aim of trying to meet these types of needs of people with cancer, the present research will evaluate the effectiveness of a peer support program in cancer patients, based on the support provided or exchanged by people who have faced similar challenges or problems. The intervention will consist of 8 face-to-face sessions of social peer support, involving a cancer patient and a volunteer who is in a stable phase and who has undergone the same diagnosis and medical treatment. To evaluate the effectiveness of the social support program, the immediate and long-term effect of participation in the program on both psychological (anxious-depressive symptoms, quality of life, perception of the disease, coping strategies, perception of social support,...) and biological (endocrine and immune system) variables will be analyzed.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• relapse; suffering or having suffered from a severe mental disorder (according to DSM-V criteria).

Related Conditions & MeSH terms

• Neoplasms
• Psychological Distress
• Social Skills

Intervention

Behavioral:
• Peer support program
The intervention will consist of 8 face-to-face peer social support sessions conducted by volunteers diagnosed with breast 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.

Locations

Country	Name	City	State
Spain	Onkologikoa	San Sebastián	Guipuzcoa

Sponsors (2)

Lead Sponsor	Collaborator
Joana Perez Tejada	University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological distress scale HADS	Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.	baseline
Primary	Social support perception scale MOS-SSS	The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception	baseline
Primary	Coping scale COPE28	The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping	baseline
Primary	Resilience scale	The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience	baseline
Primary	Quality of life scale SF-12	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.	baseline
Primary	emotional inteligence scale TMMS	The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, & Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence	baseline
Primary	illness perception scale	The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception	baseline
Primary	Cortisol levels	Cortisol is a hormone that is mainly released at times of stress	baseline
Primary	Cytokine levels of IL-6 and TNF-a	Cytokines are a broad and loose category of small proteins (~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms	baseline
Primary	Estradiol levels	Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression	baseline
Primary	Monoamines levels	Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.	baseline
Primary	Psychological distress scale HADS	Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression. Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing.	four months after
Primary	Social support perception scale MOS-SSS	The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception	four months after
Primary	Coping scale COPE28	The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping	four months after
Primary	Resilience scale	The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience	four months after
Primary	Quality of life scale SF-12	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.	four months after
Primary	emotional inteligence scale TMMS	The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, & Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence	four months after
Primary	illness perception scale	The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception	four months after
Primary	Cortisol levels	Cortisol is a hormone that is mainly released at times of stress	four months after
Primary	Cytokine levels of IL-6 and TNF-a	Cytokines are a broad and loose category of small proteins (~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms	four months after
Primary	Estradiol levels	Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression	four months after
Primary	Monoamines levels	Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.	four months after
Primary	Psychological distress scale HADS	Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.	through treatment completion, an average of eight months
Primary	Social support perception scale MOS-SSS	The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception	through treatment completion, an average of eight months
Primary	Coping scale COPE28	The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping	through treatment completion, an average of eight months
Primary	Resilience scale	The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience	through treatment completion, an average of eight months
Primary	Quality of life scale SF-12	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.	through treatment completion, an average of eight months
Primary	emotional inteligence scale TMMS	The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, & Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence	through treatment completion, an average of eight months
Primary	illness perception scale	The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception	through treatment completion, an average of eight months
Primary	Cortisol levels	Cortisol is a hormone that is mainly released at times of stress	through treatment completion, an average of eight months
Primary	Cytokine levels of IL-6 and TNF-a	Cytokines are a broad and loose category of small proteins (~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms	through treatment completion, an average of eight months
Primary	Estradiol levels	Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression	through treatment completion, an average of eight months
Primary	Monoamines levels	Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.	through treatment completion, an average of eight months
Primary	Psychological distress scale HADS	Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.	four months after treatment completion
Primary	Social support perception scale MOS-SSS	The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception	four months after treatment completion
Primary	Coping scale COPE28	The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping	four months after treatment completion
Primary	Resilience scale	The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience	four months after treatment completion
Primary	Quality of life scale SF-12	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.	four months after treatment completion
Primary	emotional inteligence scale TMMS	The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, & Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence	four months after treatment completion
Primary	illness perception scale	The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception	four months after treatment completion
Primary	Cortisol levels	Cortisol is a hormone that is mainly released at times of stress	four months after treatment completion
Primary	Cytokine levels of IL-6 and TNF-a	Cytokines are a broad and loose category of small proteins (~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms	four months after treatment completion
Primary	Estradiol levels	Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression	fofour months after treatment completion
Primary	Monoamines levels	Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.	four months after treatment completion
Primary	Psychological distress scale HADS	Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.	one year after treatment completion
Primary	Social support perception scale MOS-SSS	The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception	one year after treatment completion
Primary	Coping scale COPE28	The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping	one year after treatment completion
Primary	Resilience scale	The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience	one year after treatment completion
Primary	Quality of life scale SF-12	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.	one year after treatment completion
Primary	emotional inteligence scale TMMS	The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, & Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence	one year after treatment completion
Primary	illness perception scale	The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception	one year after treatment completion
Primary	Cortisol levels	Cortisol is a hormone that is mainly released at times of stress	one year after treatment completion
Primary	Cytokine levels of IL-6 and TNF-a	Cytokines are a broad and loose category of small proteins (~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms	one year after treatment completion
Primary	Estradiol levels	Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression	one year after treatment completion
Primary	Monoamines levels	Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.	one year after treatment completion