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Peer Support Program in Cancer Patients Elkar Laguntza (ElkarLaguntz)

J

Joana Perez Tejada

Status

Enrolling

Conditions

Neoplasms
Social Skills
Psychological Distress

Treatments

Behavioral: Peer support program

Study type

Interventional

Funder types

Other

Identifiers

NCT05077371
2019
PI2018068

Details and patient eligibility

About

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.

Full 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).

Enrollment

120 estimated patients

Sex

Female

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

120 participants in 2 patient groups

Experimental group 1
Experimental group
Description:
newly diagnosed breast cancer patients receiving the peer support program at the beginning of their medical treatment.
Treatment:
Behavioral: Peer support program
Experimental group 2
Experimental group
Description:
newly diagnosed breast cancer patients receiving the social peer support program at the end of their medical treatment.
Treatment:
Behavioral: Peer support program

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Amaia Arregi; Joana Perez Tejada

Data sourced from clinicaltrials.gov

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