Peer Support Program in Cancer Patients Elkar Laguntza

NCT ID: NCT05077371

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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).

Conditions

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Neoplasms Social Skills Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental group 1

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

Group Type EXPERIMENTAL

Peer support program

Intervention Type 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 2

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

Group Type EXPERIMENTAL

Peer support program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role collaborator

Joana Perez Tejada

OTHER

Sponsor Role lead

Responsible Party

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Joana Perez Tejada

Psychology researcher

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Onkologikoa

San Sebastián, Guipuzcoa, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Joana Perez Tejada

Role: CONTACT

943328140

Amaia Arregi

Role: CONTACT

943015217

Facility Contacts

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Joana Perez

Role: primary

943328140

References

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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.

Reference Type DERIVED
PMID: 38885598 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019

Identifier Type: OTHER

Identifier Source: secondary_id

PI2018068

Identifier Type: -

Identifier Source: org_study_id

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