Clinical trial NCT05077371: Peer Support Program in Cancer Patients Elkar Laguntza
Official title: Peer Support Program in cáncer Patients Elkar Laguntza
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Social Skills
Psychological Distress
Lead sponsor: Onkologikoa
Sponsor class: OTHER
Collaborators: name: University of the Basque Country (UPV/EHU)
First posted: 2021-10-14
Enrollment: 120
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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).

Primary outcomes:
measure: Psychological distress scale HADS
timeFrame: baseline
measure: Social support perception scale MOS-SSS
timeFrame: baseline
measure: Coping scale COPE28
timeFrame: baseline
measure: Resilience scale
timeFrame: baseline
measure: Quality of life scale SF-12
timeFrame: baseline
measure: emotional inteligence scale TMMS
timeFrame: baseline
measure: illness perception scale
timeFrame: baseline
measure: Cortisol levels
timeFrame: baseline
measure: Cytokine levels of IL-6 and TNF-a
timeFrame: baseline
measure: Estradiol levels
timeFrame: baseline
measure: Monoamines levels
timeFrame: baseline
measure: Psychological distress scale HADS
timeFrame: four months after
measure: Social support perception scale MOS-SSS
timeFrame: four months after
measure: Coping scale COPE28
timeFrame: four months after
measure: Resilience scale
timeFrame: four months after
measure: Quality of life scale SF-12
timeFrame: four months after
measure: emotional inteligence scale TMMS
timeFrame: four months after
measure: illness perception scale
timeFrame: four months after
measure: Cortisol levels
timeFrame: four months after
measure: Cytokine levels of IL-6 and TNF-a
timeFrame: four months after
measure: Estradiol levels
timeFrame: four months after
measure: Monoamines levels
timeFrame: four months after
measure: Psychological distress scale HADS
timeFrame: through treatment completion, an average of eight months
measure: Social support perception scale MOS-SSS
timeFrame: through treatment completion, an average of eight months
measure: Coping scale COPE28
timeFrame: through treatment completion, an average of eight months
measure: Resilience scale
timeFrame: through treatment completion, an average of eight months
measure: Quality of life scale SF-12
timeFrame: through treatment completion, an average of eight months
measure: emotional inteligence scale TMMS
timeFrame: through treatment completion, an average of eight months
measure: illness perception scale
timeFrame: through treatment completion, an average of eight months
measure: Cortisol levels
timeFrame: through treatment completion, an average of eight months
measure: Cytokine levels of IL-6 and TNF-a
timeFrame: through treatment completion, an average of eight months
measure: Estradiol levels
timeFrame: through treatment completion, an average of eight months
measure: Monoamines levels
timeFrame: through treatment completion, an average of eight months
measure: Psychological distress scale HADS
timeFrame: four months after treatment completion
measure: Social support perception scale MOS-SSS
timeFrame: four months after treatment completion
measure: Coping scale COPE28
timeFrame: four months after treatment completion
measure: Resilience scale
timeFrame: four months after treatment completion
measure: Quality of life scale SF-12
timeFrame: four months after treatment completion
measure: emotional inteligence scale TMMS
timeFrame: four months after treatment completion
measure: illness perception scale
timeFrame: four months after treatment completion
measure: Cortisol levels
timeFrame: four months after treatment completion
measure: Cytokine levels of IL-6 and TNF-a
timeFrame: four months after treatment completion
measure: Estradiol levels
timeFrame: fofour months after treatment completion
measure: Monoamines levels
timeFrame: four months after treatment completion
measure: Psychological distress scale HADS
timeFrame: one year after treatment completion
measure: Social support perception scale MOS-SSS
timeFrame: one year after treatment completion
measure: Coping scale COPE28
timeFrame: one year after treatment completion
measure: Resilience scale
timeFrame: one year after treatment completion
measure: Quality of life scale SF-12
timeFrame: one year after treatment completion
measure: emotional inteligence scale TMMS
timeFrame: one year after treatment completion
measure: illness perception scale
timeFrame: one year after treatment completion
measure: Cortisol levels
timeFrame: one year after treatment completion
measure: Cytokine levels of IL-6 and TNF-a
timeFrame: one year after treatment completion
measure: Estradiol levels
timeFrame: one year after treatment completion
measure: Monoamines levels
timeFrame: one year after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Onkologikoa
state: Guipuzcoa
Study officials:
References: