Peer Support Program in Cancer Patients Elkar Laguntza

NCT05077371 | Unknown DMC

• 2 other identifiers: PI20180682019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Social Skills; Psychological Distress

Outcome Measures

Primary Outcomes (55)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Cortisol levels

  Cortisol is a hormone that is mainly released at times of stress

  baseline

• 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

• Estradiol levels

  Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression

  baseline

• Monoamines levels

  Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.

  baseline

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Cortisol levels

  Cortisol is a hormone that is mainly released at times of stress

  four months after

• 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

• 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

• Monoamines levels

  Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.

  four months after

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Cortisol levels

  Cortisol is a hormone that is mainly released at times of stress

  through treatment completion, an average of eight months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Cortisol levels

  Cortisol is a hormone that is mainly released at times of stress

  four months after treatment completion

• 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

• 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

• Monoamines levels

  Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.

  four months after treatment completion

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Cortisol levels

  Cortisol is a hormone that is mainly released at times of stress

  one year after treatment completion

• 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

• 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

• Monoamines levels

  Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.

  one year after treatment completion

Study Arms (2)

Experimental group 1

EXPERIMENTAL

newly diagnosed breast cancer patients receiving the peer support program at the beginning of their medical treatment.

Behavioral: Peer support program

Experimental group 2

EXPERIMENTAL

newly diagnosed breast cancer patients receiving the social peer support program at the end of their medical treatment.

Behavioral: Peer support program

Interventions

Peer support program BEHAVIORAL

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 group 1; Experimental group 2

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Joana Perez Tejada: lead
• University of the Basque Country (UPV/EHU): collaborator

Study Sites (1)

Onkologikoa

San Sebastián, Guipuzcoa, 20014, Spain

RECRUITING

Related Publications (1)

• Aizpurua-Perez I, Arregi A, Gonzalez D, Urruticoechea A, Labaka A, Minguez-Alcaide X, Ugartemendia G, Pascual-Sagastizabal E, Echeverria R, Perez-Tejada J. A randomized controlled trial of the effectiveness of a one-to-one peer support intervention on resilience, social support, and salivary cortisol in recently diagnosed women with breast cancer. Eur J Oncol Nurs. 2024 Aug;71:102616. doi: 10.1016/j.ejon.2024.102616. Epub 2024 May 21.

  PMID: 38885598 DERIVED

MeSH Terms

Conditions

Neoplasms; Social Skills

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Joana Perez Tejada

CONTACT

943328140; jperez@onkologikoa.org

Amaia Arregi

CONTACT

943015217; amaia.arregi@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychology researcher

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 14, 2021
• Study Start: June 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

ES (1)