Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors.
Condition: Breastcancer; Emotional Disorder; Distress
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      Psychosocial treatments in cancer survivors have demonstrated their efficacy in reducing
      emotional distress and improving Quality of Life (QoL). Providing access to a psychosocial
      intervention at the end of a curative cancer treatment becomes worthwhile, not only because
      it reduces the use of other medical resources and promotes return-to-work, but also because
      it facilitates oncological treatment adherence and the adoption of healthy lifestyles. Online
      psychosocial treatments are a good option because of their easy access, anonymity and low
      cost. The study is a sequential multicenter, controlled and randomized clinical trial
      organized in two stages. It is worth highlighting that there was a deviance from the initial
      research plan which contemplated a three-arm clinical trial. However, during the preparation
      of the recruitment phase, we faced some problems related to the opening of the third arm
      (online group positive psychotherapy) due to the fact that the required technology that
      supported the online group psychotherapy was not available for use at that moment. As a
      result, we decided to wait for a few months before we activate the third arm of the study. In
      conclusion, the study 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). Those breast cancer survivors who have showed moderate or severe adaptation problems
      after the completion of their oncological treatment will be randomly assigned to PPC versus
      CBSM group for the first stage of the study (January 2013-December 2015), and for the second
      stage, a different group of breast cancer survivors will be assigned to PPC versus OPCC
      (January 2016-February 2019). Regarding the methodology of the study, participants from the 4
      groups will be evaluated using a battery of measures at the beginning of the study (T0),
      post-treatment (T1), 3 months from T1 (T2) and 12 months from T2 (T3). Therefore, this study
      will use a factorial design of 3 (treatment conditions) x 4 (evaluation points).The main
      outcome measures include: quality of life, anxiety, depression, post-traumatic stress and
      post-traumatic growth. Secondary outcome measures will be: healthy lifestyles, adherence to
      the oncological treatment, perceived social support, and the number of return-to-work days
      after the cancer treatment completion.

      Data will be analyzed using SPSS 21.0 version. 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. 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. Besides, the
      presential format will be more effective for severely distressed patients with previous
      history of trauma, while the online format will be more effective for younger patients with
      mild emotional distress.
    

Intervention name(s): Positive Psychotherapy; Positive Online Psychotherapy; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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).; 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.; 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.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The current clinical trial is a sequential RCT. In the first stage, it compares the effectiveness of the Positive Psychotherapy for Cancer with one of the most proved Cognitive-Behavioral Psychotherapies in Cancer, which is the Cognitive Behavioral Stress Management (CBSM). In the other stage, the common presential version of the Positive Psychotherapy is compared with its online version.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: positive psychotherapy, online, breast cancer, survivors