Breast CancerICOnnectat-BNCT04372459
Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors
A study testing Online integrated and stepped psychosocial care and Usual psychosocial care in people with Breast Cancer and Psychological Distress, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
This multicenter randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Psychological Distress, Emotional Disorder
- What is being tested?
- Online integrated and stepped psychosocial care and Usual psychosocial care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jun 2021to 30 Jul 2023
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 70 years with BC, within 6 weeks after diagnosis.
- Having online access and a user-level knowledge of Internet.
- Understanding of Spanish language.
Who cannot join
- Major depressive episode.
- Significant autolytic ideation.
- Showing symptoms of psychosis or substance abuse.
- Intellectual disability.
- Having a mobile phone with an old release of Android operating system, which is not compatible with the platform.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors: A Randomized Controlled Trial
This multicenter randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. The outcomes of both interventions will be compared in terms of the amount of waiting time to receive psychosocial care and changes in several psychosocial variables. Finally, a comparative economic analysis will be conducted in other relevant psychosocial and health parameters. The e-health platform is expected to outperform usual care in the aforementioned indicators, while reaching high acceptability and usability by survivors, and additionally reducing costs for health providers.
Read the detailed description
Cancer diagnosis and treatment causes a huge psychosocial impact on breast cancer survivors. Psychosocial treatments in cancer survivors have already demonstrated their effectiveness in reducing emotional distress and improving quality of life although the access to them still presents important barriers, such as poor early detection, long waiting times for diagnosis or treatment, as well as other restrictions related to work, mobility or economic situation. In addition, the current digitization of screening, monitoring and psychosocial treatment poses a revolution in the improvement of the quality of care and the reduction of its economic burden. The objectives of this study are, first, to assess the clinical efficacy of an e-health platform that includes integrated and stepped psychosocial services, in comparison to usual psychosocial care, and second, to examine its cost-utility.
The study methodology is that of a multicentre randomised controlled trial with 2 parallel groups (experimental versus control group). Approximately 193 patients diagnosed with breast cancer in the acute survival phase will be recruited from 3 University hospitals in Catalonia (Spain) and will be randomised to one of two treatment conditions. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include detection of clinical cases, amount of waiting time from detection to psychosocial intervention, and proportion of cases solved in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth and therapeutic alliance. Secondary outcomes will include the acceptability of the platform by patients through satisfaction questionnaires and the usability of the platform. For the cost-utility analysis, the investigators will assess quality-adjusted life years (QALYs) and costs related to the number of days of sick leaves, healthcare utilization, adherence to pharmacological treatment, health professionals' costs, infrastructure and transport costs.
The study will provide an important advance in the treatment of breast cancer; in the long term, it is expected to improve the quality of patient care and the treatment efficacy and to reduce waiting lists as well as direct and indirect costs associated with the treatment of the disease in Spain.
- Conditions
- Breast Cancer, Psychological Distress, Emotional Disorder
- Being tested
- Online integrated and stepped psychosocial care, Usual psychosocial care
- Keywords
- e-health, breast cancer, survivors, psychosocial care, distress, Randomised Controlled Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online integrated and stepped psychosocial careBehavioural
This program features four levels of care, increasing in intensity of psychosocial care as patients move from one level to the next one.
Step 1: Screening and monitoring of several psychosocial variables through the central mobile application of the program (App ICOnnecta't).
Step 2: Online guided and self-help psychoeducation Campus in which patients can consult videos and online resources, co-constructed between health professionals and patients, containing reliable and rigorous information related to the oncological process.
Step 3: Online community of psychosocial support. Participants can choose from 12 cancer-related discussion forums and share with the community any health-related question that worries them fostering, thus, debate and stimulating peer-support.
Step 4: Intensive online group psychotherapy (App ICOnnecta't Videoconsultation), based on the Group Positive Psychotherapy program for cancer survivors (Ochoa, Sumalla, Maté, Castejón, Rodríguez et al., 2010).
Usual psychosocial careBehavioural
This active control group will receive the standard psychosocial treatment for cancer survivors in the participating centers, led by a clinical psychologist and consisting of 8 individual, 45/60-minute sessions, each of which every 1-2 months, focused on providing emotional support and psychoeducation during the first year of primary cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Online integrated and stepped psychosocial care | Experimental | A group of breast cancer survivors will be randomly allocated (1:1 allocation) to the online integrated and stepped psychosocial care group Receives: Behavioral: Online integrated and stepped psychosocial care |
| Usual psychosocial care | Experimental | A group of breast cancer survivors will be randomly allocated (1:1 allocation) to the usual psychosocial care group Receives: Behavioral: Usual psychosocial care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Distress (HADS)
Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983; Spanish validation by Costa-Requena, Pérez Martín, Salamero Baró, \& Gil Moncayo, 2009). It consists of 14 items, 7 for anxiety and 7 for depression, on a four-point Likert scale (range 0-3), with the total score ranging from 0 to 42. Higher scores indicate a greater level of distress.
Measured: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Change in Post-traumatic Stress (PCL-5)
Post-traumatic Stress Disorder Checklist-Civilian version (PCL-5) (Blevins, Weathers, Davis, Witte, \& Domino, 2015). The official Spanish translation of the instrument was provided by the National Center for Post-Traumatic Stress Disorder (www.ptsd.va.gov/). The PCL-5 is a 20-item questionnaire, corresponding to the "Diagnostic and Statistical Manual for Mental Disorders Version 5" symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating worse outcomes.
Measured: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Change in Post-traumatic Growth (PTGI)
Post-traumatic Growth Inventory (PTGI) (Tedeschi \& Calhoun, 1996; Spanish validation by Costa-Requena and Gil, 2007). It is a 21-item instrument based on a 6-point Likert scale (0=no change - 5=very high degree of change), which assesses positive changes experienced after a trauma. Total scores range from 0 to 105 with higher scores indicating better outcomes.
Measured: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Change in Therapeutic alliance (WAI-P)
Working Alliance Inventory-Patient Version (WAI-P; Horvath, 1981; Horvath \& Greenberg, 1986, 1989; Spanish validation by Andrade-González \& Fernández-Liria, 2015). It consists of 36 items with seven possible response options (1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, 7 = always). The scoring range of the overall WAI-P is 36-252 points with higher scores indicating better outcomes.
Measured: Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Change in Quality of Life (EQ-5D-3L)
EuroQoL-EQ-5D-3L (EuroQol Group, 1990; Spanish validation by Abadia et al., 1999). It consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Total scores range from 0-100 with higher scores indicating better outcomes.
Measured: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Secondary outcomes (6)
Healthcare utilization
Total number of visits to each healthcare professional (oncologist, nursing staff, psychologist, psychiatrist, social worker, emergency department) (Electronic Health Record).
Measured: Time 4: 12 months post-intervention
Change in Medication use and adherence (ARMS)
Adherence to Refills and Medications Scale (ARMS; Kripalani, Risser, Gatti, \& Jacobson, 2009; Spanish validation by Gonzalez-Bueno et al., 2017). It consists of 12 questions: 8 aimed at assessing the patient's ability to properly administer the medication and 4 regarding its correct intake based on a four-point Likert scale (range from 1=never to 4=always; total score range 12-48), with lower scores indicating better adherence.
Measured: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Work absenteeism
Number of days of patients' sick leaves (Electronic Health Record).
Measured: Time 4: 12 months post-intervention
Professionals' salaries
Number of professionals involved in the online treatment or usual care as well as the number of professionals' working hours per week and costs (Electronic Health Record).
Measured: Time 4: 12 months post-intervention
Infrastructure costs
Costs per user and per month for the development and maintenance of the online platform (experimental group) and costs of hospital's infrastructure per face-to-face visits per user and month.
Measured: Time 4: 12 months post-intervention
Transport costs
Cost estimate per patient using a specific transport according to mobility data in Catalonia area.
Measured: Time 4: 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start21 Jun 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Parallel groups
- Model description
- The current clinical trial is a multicenter Randomised Controlled Trial with 2 parallel groups. The effectiveness of the online integrated and stepped psychosocial care group will be compared with the usual psychosocial care group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 184 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, L'Hospitalet de Llobregat, Barcelona, Spain, 08908
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372459
- Sponsor's protocol ID
- ICOnnectat-BC
- Other IDs
- PI19/01880
- Acronym
- ICOnnectat-B
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following IPD are to be shared with other researchers: Age (aggregated), civil status (aggregated), education (aggregated), occupational status (aggregated), date of enrolment (aggregated), date of opt out (aggregated and if applicable), date of oncological diagnosis (aggregated), cancer stage, oncological treatment (aggregated), psychotropic medication (aggregated), treatment arm in the study, and results from scales and subscales of psychometric instruments. Only ITT participants' data will be retained in the dataset.
Publications
Ochoa-Arnedo C, Medina JC, Flix-Valle A, Anastasiadou D. E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Mar 8;11(3):e041548. doi: 10.1136/bmjopen-2020-041548.
PubMed 34006024
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04372459
- Acronym / sponsor ID
- ICOnnectat-B / ICOnnectat-BC
- Conditions
- Breast Cancer, Psychological Distress, Emotional Disorder
- Keywords
- e-health, breast cancer, survivors, psychosocial care, distress, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 4 May 2020 (actual)
- 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 randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. The outcomes of both interventions will be compared in terms of the amount of waiting time to receive psychosocial care and changes in several psychosocial variables. Finally, a comparative economic analysis will be conducted in other relevant psychosocial and health parameters. The e-health platform is expected to outperform usual care in the aforementioned indicators, while reaching high acceptability and usability by survivors, and additionally reducing costs for health providers.
Detailed description
Cancer diagnosis and treatment causes a huge psychosocial impact on breast cancer survivors. Psychosocial treatments in cancer survivors have already demonstrated their effectiveness in reducing emotional distress and improving quality of life although the access to them still presents important barriers, such as poor early detection, long waiting times for diagnosis or treatment, as well as other restrictions related to work, mobility or economic situation. In addition, the current digitization of screening, monitoring and psychosocial treatment poses a revolution in the improvement of the quality of care and the reduction of its economic burden. The objectives of this study are, first, to assess the clinical efficacy of an e-health platform that includes integrated and stepped psychosocial services, in comparison to usual psychosocial care, and second, to examine its cost-utility.
The study methodology is that of a multicentre randomised controlled trial with 2 parallel groups (experimental versus control group). Approximately 193 patients diagnosed with breast cancer in the acute survival phase will be recruited from 3 University hospitals in Catalonia (Spain) and will be randomised to one of two treatment conditions. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include detection of clinical cases, amount of waiting time from detection to psychosocial intervention, and proportion of cases solved in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth and therapeutic alliance. Secondary outcomes will include the acceptability of the platform by patients through satisfaction questionnaires and the usability of the platform. For the cost-utility analysis, the investigators will assess quality-adjusted life years (QALYs) and costs related to the number of days of sick leaves, healthcare utilization, adherence to pharmacological treatment, health professionals' costs, infrastructure and transport costs.
The study will provide an important advance in the treatment of breast cancer; in the long term, it is expected to improve the quality of patient care and the treatment efficacy and to reduce waiting lists as well as direct and indirect costs associated with the treatment of the disease in Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The current clinical trial is a multicenter Randomised Controlled Trial with 2 parallel groups. The effectiveness of the online integrated and stepped psychosocial care group will be compared with the usual psychosocial care group
| Arm | Type | Receives |
|---|---|---|
| Online integrated and stepped psychosocial care | Experimental | Behavioral: Online integrated and stepped psychosocial careA group of breast cancer survivors will be randomly allocated (1:1 allocation) to the online integrated and stepped psychosocial care group |
| Usual psychosocial care | Experimental | Behavioral: Usual psychosocial careA group of breast cancer survivors will be randomly allocated (1:1 allocation) to the usual psychosocial care group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 70 years with BC, within 6 weeks after diagnosis.
- Having online access and a user-level knowledge of Internet.
- Understanding of Spanish language.
Key exclusion criteria (5 listed)
- Major depressive episode.
- Significant autolytic ideation.
- Showing symptoms of psychosis or substance abuse.
- Intellectual disability.
- Having a mobile phone with an old release of Android operating system, which is not compatible with the platform.
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 |
|---|---|---|
| Online integrated and stepped psychosocial careThis program features four levels of care, increasing in intensity of psychosocial care as patients move from one level to the next one. Step 1: Screening and monitoring of several psychosocial variables through the central mobile application of the program (App ICOnnecta't). Step 2: Online guided and self-help psychoeducation Campus in which patients can consult videos and online resources, co-constructed between health professionals and patients, containing reliable and rigorous information related to the oncological process. Step 3: Online community of psychosocial support. Participants can choose from 12 cancer-related discussion forums and share with the community any health-related question that worries them fostering, thus, debate and stimulating peer-support. Step 4: Intensive online group psychotherapy (App ICOnnecta't Videoconsultation), based on the Group Positive Psychotherapy program for cancer survivors (Ochoa, Sumalla, Maté, Castejón, Rodríguez et al., 2010). | Behavioural | Online integrated and stepped psychosocial care |
| Usual psychosocial careThis active control group will receive the standard psychosocial treatment for cancer survivors in the participating centers, led by a clinical psychologist and consisting of 8 individual, 45/60-minute sessions, each of which every 1-2 months, focused on providing emotional support and psychoeducation during the first year of primary cancer treatment. | Behavioural | Usual psychosocial care |
Primary outcome
Change in Emotional Distress (HADS)
Time frame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983; Spanish validation by Costa-Requena, Pérez Martín, Salamero Baró, \& Gil Moncayo, 2009). It consists of 14 items, 7 for anxiety and 7 for depression, on a four-point Likert scale (range 0-3), with the total score ranging from 0 to 42. Higher scores indicate a greater level of distress.
Change in Post-traumatic Stress (PCL-5)
Time frame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Post-traumatic Stress Disorder Checklist-Civilian version (PCL-5) (Blevins, Weathers, Davis, Witte, \& Domino, 2015). The official Spanish translation of the instrument was provided by the National Center for Post-Traumatic Stress Disorder (www.ptsd.va.gov/). The PCL-5 is a 20-item questionnaire, corresponding to the "Diagnostic and Statistical Manual for Mental Disorders Version 5" symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating worse outcomes.
Change in Post-traumatic Growth (PTGI)
Time frame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Post-traumatic Growth Inventory (PTGI) (Tedeschi \& Calhoun, 1996; Spanish validation by Costa-Requena and Gil, 2007). It is a 21-item instrument based on a 6-point Likert scale (0=no change - 5=very high degree of change), which assesses positive changes experienced after a trauma. Total scores range from 0 to 105 with higher scores indicating better outcomes.
Change in Therapeutic alliance (WAI-P)
Time frame: Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Working Alliance Inventory-Patient Version (WAI-P; Horvath, 1981; Horvath \& Greenberg, 1986, 1989; Spanish validation by Andrade-González \& Fernández-Liria, 2015). It consists of 36 items with seven possible response options (1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, 7 = always). The scoring range of the overall WAI-P is 36-252 points with higher scores indicating better outcomes.
Change in Quality of Life (EQ-5D-3L)
Time frame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
EuroQoL-EQ-5D-3L (EuroQol Group, 1990; Spanish validation by Abadia et al., 1999). It consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Total scores range from 0-100 with higher scores indicating better outcomes.
6 secondary outcomes
Healthcare utilization
Time frame: Time 4: 12 months post-intervention
Change in Medication use and adherence (ARMS)
Time frame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Work absenteeism
Time frame: Time 4: 12 months post-intervention
Professionals' salaries
Time frame: Time 4: 12 months post-intervention
Infrastructure costs
Time frame: Time 4: 12 months post-intervention
Transport costs
Time frame: Time 4: 12 months post-intervention
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 6 Mar 2024.
- Derived from this study: PubMed 34006024Ochoa-Arnedo C, Medina JC, Flix-Valle A, Anastasiadou D. E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Mar 8;11(3):e041548. doi: 10.1136/bmjopen-2020-041548.
- Individual participant dataSharing planned: Yes. The following IPD are to be shared with other researchers: Age (aggregated), civil status (aggregated), education (aggregated), occupational status (aggregated), date of enrolment (aggregated), date of opt out (aggregated and if applicable), date of oncological diagnosis (aggregated), cancer stage, oncological treatment (aggregated), psychotropic medication (aggregated), treatment arm in the study, and results from scales and subscales of psychometric instruments. Only ITT participants' data will be retained in the dataset.
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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, L'Hospitalet de Llobregat, Barcelona, Spain, 08908
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online integrated and stepped psychosocial care and Usual psychosocial care in people with Breast Cancer and Psychological Distress, 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 3 inclusion and 5 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 6 Mar 2024. 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 Emotional Distress (HADS) (time frame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention). The study lists 5 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 NCT04372459, which also lists 1 linked publication.
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 6 Mar 2024.