Clinical trial · Interventional
Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors.
Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors: A Multicentre Randomised Controlled Trial. Efficacy, Medical Cost Offset and Treatment Predictors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter study is a sequential RCT which aims to prove, in the first stage, the efficacy of a face-to-face Positive Psychotherapy in Cancer (PPC) group compared to a Cognitive Behavioral Stress Management (CBSM) group. In the second stage, the common face-to-face version of the PPC will be compared with its online version via videoconference (Online group Positive Psychotherapy, OPPC) among a group of primary breast cancer survivors. The principal dependent variables assessed will be emotional distress, post-traumatic growth (PTG) and quality of life (QoL). Some treatment predictors of psychosocial response will be explored. Lastly, an economic analysis focused on the Quality Adjusted Life Years (QALY) will be carried out at each stage. For the first stage, we hypothesize that the PCC group would achieve similar efficacy in reducing participants' distress compared to the CBSM group, while the PCC group would show greater improvement in PTG than the CBSM group. For the second stage, it is hypothesized that the OPCC would achieve similar efficacy in all psychosocial variables and guarantee equivalent retention and adherence compared to face-to-face PPC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breastcancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Distress | — | UNRESOLVED | — |
| Emotional Disorder | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | — | UNRESOLVED |
| Positive Online Psychotherapy | Behavioral | — | UNRESOLVED |
| Positive Psychotherapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Positive Psychotherapy
- description
- A group of breast cancer survivors are randomly allocated to the presential version of the positive psychotherapy
- interventionNames
- Behavioral: Positive Psychotherapy
- type
- EXPERIMENTAL
- label
- Positive Online Psychotherapy
- description
- A group of breast cancer survivors are randomly allocated to the online version of the positive psychotherapy
- interventionNames
- Behavioral: Positive Online Psychotherapy
- type
- EXPERIMENTAL
- label
- Cognitive Behavioral Therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with primary breast cancer, * Having completed the curative treatment and / or adjuvant treatment for their primary tumor in the last 1 to 6 months * Be able to use the Internet in a private place and have a knowledge of Internet at the user level * Scoring ≥ 5 points on the thermometer for emotional distress (anxiety and depression) and confirmed with a score on the HADS total scale ≥ 10 in the admission interview. Exclusion Criteria: * Severe major depressive episode or significant autolytic ideation * Showing symptoms of psychosis or substance abuse. * If a participant relapses or progresses from her illness during the study period, the clinical psychologist responsible for the therapeutic group to which is assigned will ask the participant if they want to be referred to their hospital for individual psychological treatment.
References
Publications (3)
- BACKGROUNDOchoa C, Sumalla EC, Maté J, Castejón V, Rodríguez A, Blanco I, Gil F. Psicoterapia positiva grupal en cáncer. Hacia una atención psicosocial integral del superviviente de cáncer. Psicooncología 7(1):7-34, 2010.
- BACKGROUNDOchoa C, Casellas-Grau A, Vives J, Font A, Borras JM. Positive psychotherapy for distressed cancer survivors: Posttraumatic growth facilitation reduces posttraumatic stress. Int J Clin Health Psychol. 2017 Jan-Apr;17(1):28-37. doi: 10.1016/j.ijchp.2016.09.002. Epub 2016 Oct 18. PMID 30487878
- DERIVEDLleras de Frutos M, Medina JC, Vives J, Casellas-Grau A, Marzo JL, Borras JM, Ochoa-Arnedo C. Video conference vs face-to-face group psychotherapy for distressed cancer survivors: A randomized controlled trial. Psychooncology. 2020 Dec;29(12):1995-2003. doi: 10.1002/pon.5457. Epub 2020 Aug 7. PMID 32618395