BreastcancerPSONLINENCT03010371
Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors.
A study testing Positive Psychotherapy, Positive Online Psychotherapy and Cognitive Behavioral Therapy in people with Breastcancer and Emotional Disorder, run by Institut Català d'Oncologia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breastcancer, Emotional Disorder, Distress
- What is being tested?
- Positive Psychotherapy, Positive Online Psychotherapy and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors: A Multicentre Randomised Controlled Trial. Efficacy, Medical Cost Offset and Treatment Predictors.
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.
Read the 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.
- Conditions
- Breastcancer, Emotional Disorder, Distress
- Being tested
- Positive Psychotherapy, Positive Online Psychotherapy, Cognitive Behavioral Therapy
- Keywords
- positive psychotherapy, online, breast cancer, survivors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychotherapyBehavioural
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 Online PsychotherapyBehavioural
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.
Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychotherapy | Experimental | A group of breast cancer survivors are randomly allocated to the presential version of the positive psychotherapy Receives: Behavioral: Positive Psychotherapy |
| Positive Online Psychotherapy | Experimental | A group of breast cancer survivors are randomly allocated to the online version of the positive psychotherapy Receives: 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) Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Healthy lifestyles. It will be assessed through the Self-Report of Non-Healthy Habits. (Capdevila, 2005).
Measured: 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)
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.
Measured: Time 0 (baseline)
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.
Measured: Time T1 (post-intervention) and Time 3 (12 months from T1)
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)
Measured: Time 0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Ochoa Arnedo, Institut Català d'Oncologia
- Investigators
- Cristian Ochoa, PhD, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010371
- Sponsor's protocol ID
- ICOLH201601
- Acronym
- PSONLINE
- Status last verified
- Feb 2020
- First submitted
- 18 Dec 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
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.
PubMed 30487878Lleras 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.
PubMed 32618395
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presential Vs Online Group-based Psychosocial Treatment for Breast Cancer Survivors: A Multicentre Randomised Controlled Trial. Efficacy, Medical Cost Offset and Treatment Predictors.
- ClinicalTrials.gov ID
- NCT03010371
- Acronym / sponsor ID
- PSONLINE / ICOLH201601
- Conditions
- Breastcancer, Emotional Disorder, Distress
- Keywords
- positive psychotherapy, online, breast cancer, survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Positive Psychotherapy | Experimental | Behavioral: Positive PsychotherapyA group of breast cancer survivors are randomly allocated to the presential version of the positive psychotherapy |
| Positive Online Psychotherapy | Experimental | Behavioral: Positive Online PsychotherapyA group of breast cancer survivors are randomly allocated to the online version of the positive psychotherapy |
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyA group of breast cancer survivors are randomly allocated to the presential cognitive behavioral therapy (Cognitive Behavioral Stress Management, CBSM) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive PsychotherapyPositive 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). | Behavioural | Positive Psychotherapy |
| Positive Online PsychotherapyThe 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. | Behavioural | Positive Online Psychotherapy |
| Cognitive Behavioral TherapyThe 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Change in Posttraumatic Symptoms (patients)
Time frame: 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)
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.
Change in Posttraumatic Growth (patients)
Time frame: 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)
PTGI (Posttraumatic Growth Inventory; Tedeschi and Calhoun, 1996) validated in Spanish for patients with cancer (Costa-Requena and Gil, 2007).
Change in Distress (Anxiety and Depression) (patients)
Time frame: 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)
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.
Change in Quality of Life (patients)
Time frame: 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)
EuroQol 5D (EQ-5D) European Quality of Life Scale. Spanish version. (Abadia et al., 1999).
4 secondary outcomes
Change in Healthy Life Style (patients)
Time frame: 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 frame: Time 0 (baseline)
Days of return-to-work (patients)
Time frame: Time T1 (post-intervention) and Time 3 (12 months from T1)
Fidelity to treatment (therapists)
Time frame: Time 0 (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- BackgroundOchoa 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: PubMed 30487878Ochoa 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.
- Derived from this study: PubMed 32618395Lleras 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Ochoa, PhD principal investigator
Institut Català d'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychotherapy, Positive Online Psychotherapy and Cognitive Behavioral Therapy in people with Breastcancer and Emotional Disorder, run by Institut Català d'Oncologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posttraumatic Symptoms (patients) (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010371, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.