Emotional Disorder Clinical Trial
— PSONLINEOfficial title:
Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors: A Multicentre Randomised Controlled Trial. Efficacy, Medical Cost Offset and Treatment Predictors.
NCT number | NCT03010371 |
Other study ID # | ICOLH201601 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | February 2019 |
Verified date | February 2020 |
Source | Institut Català d'Oncologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 365 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Institut Català d'Oncologia | L'Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Institut Català d'Oncologia |
Spain,
Ochoa C, Casellas-Grau A, Vives J, Font A, Borràs 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. — View Citation
Ochoa 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time since diagnosis (patients) | Days since being diagnosed with breast cancer | Time 0 (baseline) | |
Other | Life Extreme Experiences (patients) | Inventory of Extreme Experiences (IEE) (Pérez-Sales, Cervellón, Vázquez, Vidales, and Gaborit, 2005): This instrument collects data from 34 experiences (most commonly related to trauma, loss or crisis, plus 5 vital positive events). | Time 0 (baseline) | |
Other | Biomarkers (patients) | For estrogen-alpha receptors (RE) a Dako monoclonal antibody Ref: IR657 / IS657. For progesterone receptors (RP) a Dako monoclonal antibody Ref: IR068 / IS068. For ki-67 a Dako monoclonal antibody Ref.IR626 / IS626. Finally, for Her-2 neu, herceptest Dako Ref.SK001.IR657/IS657. Para receptores de progesterona (RP) un anticuerpo monoclonal Dako Ref: IR068/IS068. Para ki-67 un anticuerpo monoclonal Dako Ref.IR626/IS626. Finalmente, para Her-2 neu, herceptest Dako Ref.SK001. | Time 0 (baseline) | |
Primary | Change in Posttraumatic Symptoms (patients) | PCL-C (Posttraumatic Checklist -Civilian Version; Weathers et al., 1991), validated in Spanish for cancer patients (Costa-Requena and Gil, 2010). It assesses the presence of symptoms of posttraumatic stress. | 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) | |
Primary | Change in Posttraumatic Growth (patients) | PTGI (Posttraumatic Growth Inventory; Tedeschi and Calhoun, 1996) validated in Spanish for patients with cancer (Costa-Requena and Gil, 2007). | 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) | |
Primary | Change in Distress (Anxiety and Depression) (patients) | HADS (Hospital Anxiety and Depression Scale; Zigmond AS & Snaith, 1983), validated in Spanish for cancer patients (Costa-Requena et al., 2009). It assesses the levels of Anxiety and Depression in patients. | 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) | |
Primary | Change in Quality of Life (patients) | EuroQol 5D (EQ-5D) European Quality of Life Scale. Spanish version. (Abadia et al., 1999). | 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) | |
Secondary | Change in Healthy Life Style (patients) | Healthy lifestyles. It will be assessed through the Self-Report of Non-Healthy Habits. (Capdevila, 2005). | 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) | |
Secondary | Perception of Social Support (patients) | MOS-SSS (Medical Outcomes Study Survey-Social Support; Sherbourne & Stewart, 1991) validated in Spanish for cancer patients (Costa, Salamero and Gil, 2007). It assesses the perception of social support. | Time 0 (baseline) | |
Secondary | Days of return-to-work (patients) | Work reincorporation. The following variables will be collected: number of days of sick leave until the return to work, changes of work and granting of total or absolute incapacity. It will be used the questionnaire devised by Nieuwenhuijsen et al. (2006) specifically to assess the return to work. | Time T1 (post-intervention) and Time 3 (12 months from T1) | |
Secondary | Fidelity to treatment (therapists) | Therapists´ fidelity to treatment will be assessed using the The Revised Cognitive Therapy Scale (CTS-R; Blackburn et al., 2000; James, Blackburn, & Reichelt, F, 2001) | Time 0 (baseline) |
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