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

NCT03010371 | Completed DMC

• 1 other identifier: ICOLH201601
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

positive psychotherapy, online, breast cancer, survivors

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Change in Healthy Life Style (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)

• Perception of Social Support (patients)

  Time 0 (baseline)

• Days of return-to-work (patients)

  Time T1 (post-intervention) and Time 3 (12 months from T1)

• Fidelity to treatment (therapists)

  Time 0 (baseline)

Other Outcomes (3)

• Time since diagnosis (patients)

  Time 0 (baseline)

• Life Extreme Experiences (patients)

  Time 0 (baseline)

• Biomarkers (patients)

  Time 0 (baseline)

Study Arms (3)

Positive Psychotherapy

EXPERIMENTAL

A group of breast cancer survivors are randomly allocated to the presential version of the positive psychotherapy

Behavioral: Positive Psychotherapy

Positive Online Psychotherapy

EXPERIMENTAL

A group of breast cancer survivors are randomly allocated to the online version of the positive psychotherapy

Behavioral: Positive Online Psychotherapy

Cognitive Behavioral Therapy

EXPERIMENTAL

A group of breast cancer survivors are randomly allocated to the presential cognitive behavioral therapy (Cognitive Behavioral Stress Management, CBSM)

Behavioral: Cognitive Behavioral Therapy

Interventions

Positive Psychotherapy BEHAVIORAL

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).

Positive Psychotherapy

Positive Online Psychotherapy BEHAVIORAL

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.

Positive Online Psychotherapy

Cognitive Behavioral Therapy BEHAVIORAL

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.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (3)

• 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.

  BACKGROUND

• Ochoa 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 BACKGROUND

• Lleras 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cristian Ochoa, PhD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: January 5, 2017
• Study Start: January 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

ES (1)