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

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.

Conditions

• Breastcancer
• Emotional Disorder
• Distress

Interventions

BEHAVIORAL

Positive Psychotherapy

Positive Psychotherapy (PP) is designed to treat cancer survivors with moderate/severe adaptation difficulties after completing cancer treatments (Ochoa et al., 2010). The objectives are the facilitation and promotion of post-traumatic growth and quality of life, and the reduction of emotional distress (anxiety, depression and post-traumatic symptoms). Secondary consequences of this psychological improvement is a better transition to daily life and the restoration of a good psychosocial functioning (labor reincorporation, adherence to treatments and follow-up, and the adoption of healthy lifestyles). The program consists of twelve sessions of 90 minutes per week in a closed group (5 to 7 participants). Each session focuses on the different topics and tasks defined in the Positive Psychotherapy for cancer survivors (Ochoa et al., 2010).

BEHAVIORAL

Positive Online Psychotherapy

The Positive Online Psychotherapy (POP) is based on the PP program, but being adapted to an online version. Patients in this experimental condition will have access to a secure virtual platform (supervised and dependent from the Catalan Health Department). The POP consists of twelve weekly sessions of 90 minutes, in a closed-group format (5-7 participants). Patients have a simultaneous group-connection to the online platform, together with a clinical psychologist who lead the tasks according to the focuses of each session.

BEHAVIORAL

Cognitive Behavioral Therapy

The Cognitive Behavioral Therapy (CBT) is based on the Cognitive Behavioral Stress Management (Antoni, 2003) and the training program derived from it, "Breast Cancer Stress Management and Relaxation Training" (B-SMART) by Antoni Michael (2003). In its Spanish version, it is a 10-session therapy aimed to reduce cancer-related emotional distress, facilitating adjustment to illness and greater quality of life. Stress management and relaxation techniques help patients to identify their own stress responses and learn alternative ways of thinking and acting in response to the demands they perceive as highly stressful.

Sponsors & Collaborators

• Institut Català d'Oncologia

  lead OTHER

Principal Investigators

• Cristian Ochoa, PhD · Institut Català d'Oncologia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2019-02-28

Completion

2019-02-28

Countries

• Spain

Study Locations