CompletedNot Applicable

Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors.

Spain365 participantsStarted 2016-01

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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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.

What they're measuring

Change in Posttraumatic Symptoms (patients)

Timeframe: Time 0 (baseline), Time 1 (change between Time 0 and post-intervention), Time 2 (change between T1 and 3 months post-intervention) and Time 3 (change between Time 2 and 12 months post-intervention)

Change in Posttraumatic Growth (patients)

Change in Distress (Anxiety and Depression) (patients)

Change in Quality of Life (patients)

Trial details

NCT IDNCT03010371

SponsorInstitut Català d'Oncologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

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