ElkarLaguntz: Peer Support Program in Cancer Patients Elkar Laguntza
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group 1 newly diagnosed breast cancer patients receiving the peer support program at the beginning of their medical treatment. |
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.
|
| Experimental: Experimental group 2 newly diagnosed breast cancer patients receiving the social peer support program at the end of their medical treatment. |
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.
|
Outcome Measures
Primary Outcome Measures
- Psychological distress scale HADS [baseline]
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.
- Social support perception scale MOS-SSS [baseline]
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
- Coping scale COPE28 [baseline]
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
- Resilience scale [baseline]
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
- Quality of life scale SF-12 [baseline]
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.
- emotional inteligence scale TMMS [baseline]
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
- illness perception scale [baseline]
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
- Cortisol levels [baseline]
Cortisol is a hormone that is mainly released at times of stress
- Cytokine levels of IL-6 and TNF-a [baseline]
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
- Estradiol levels [baseline]
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
- Monoamines levels [baseline]
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
- Psychological distress scale HADS [four months after]
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.
- Social support perception scale MOS-SSS [four months after]
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
- Coping scale COPE28 [four months after]
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
- Resilience scale [four months after]
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
- Quality of life scale SF-12 [four months after]
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.
- emotional inteligence scale TMMS [four months after]
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
- illness perception scale [four months after]
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
- Cortisol levels [four months after]
Cortisol is a hormone that is mainly released at times of stress
- Cytokine levels of IL-6 and TNF-a [four months after]
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
- Estradiol levels [four months after]
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
- Monoamines levels [four months after]
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
- Psychological distress scale HADS [through treatment completion, an average of eight months]
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.
- Social support perception scale MOS-SSS [through treatment completion, an average of eight months]
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
- Coping scale COPE28 [through treatment completion, an average of eight months]
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
- Resilience scale [through treatment completion, an average of eight months]
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
- Quality of life scale SF-12 [through treatment completion, an average of eight months]
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.
- emotional inteligence scale TMMS [through treatment completion, an average of eight months]
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
- illness perception scale [through treatment completion, an average of eight months]
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
- Cortisol levels [through treatment completion, an average of eight months]
Cortisol is a hormone that is mainly released at times of stress
- Cytokine levels of IL-6 and TNF-a [through treatment completion, an average of eight months]
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
- Estradiol levels [through treatment completion, an average of eight months]
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
- Monoamines levels [through treatment completion, an average of eight months]
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
- Psychological distress scale HADS [four months after treatment completion]
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.
- Social support perception scale MOS-SSS [four months after treatment completion]
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
- Coping scale COPE28 [four months after treatment completion]
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
- Resilience scale [four months after treatment completion]
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
- Quality of life scale SF-12 [four months after treatment completion]
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.
- emotional inteligence scale TMMS [four months after treatment completion]
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
- illness perception scale [four months after treatment completion]
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
- Cortisol levels [four months after treatment completion]
Cortisol is a hormone that is mainly released at times of stress
- Cytokine levels of IL-6 and TNF-a [four months after treatment completion]
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
- Estradiol levels [fofour months after treatment completion]
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
- Monoamines levels [four months after treatment completion]
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
- Psychological distress scale HADS [one year after treatment completion]
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.
- Social support perception scale MOS-SSS [one year after treatment completion]
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
- Coping scale COPE28 [one year after treatment completion]
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
- Resilience scale [one year after treatment completion]
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
- Quality of life scale SF-12 [one year after treatment completion]
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.
- emotional inteligence scale TMMS [one year after treatment completion]
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
- illness perception scale [one year after treatment completion]
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
- Cortisol levels [one year after treatment completion]
Cortisol is a hormone that is mainly released at times of stress
- Cytokine levels of IL-6 and TNF-a [one year after treatment completion]
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
- Estradiol levels [one year after treatment completion]
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
- Monoamines levels [one year after treatment completion]
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Onkologikoa | San Sebastián | Guipuzcoa | Spain | 20014 |
Sponsors and Collaborators
- Joana Perez Tejada
- University of the Basque Country (UPV/EHU)
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- PI2018068
- 2019