Breast NeoplasmPhase 2/3INNOVBCNCT03275727
A Guided Internet-delivered Individually-tailored ACT-influenced CBT Intervention to Improve Psychosocial Outcomes in Breast Cancer
A Phase 2/3 study testing iACT-BC in people with Breast Neoplasm, run by Linkoeping University.
Trial summary
Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- iACT-BC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Dec 2019
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age ≥ 18 years;
- Ability to read and write in Portuguese.
- History of histologically or cytologically confirmed breast cancer with no evidence of metastatic disease.
- An interval ≥ 6 month from primary adjuvant treatment completion (surgery, chemotherapy and/or radiotherapy), except for hormonal therapy.
- Clinically significant symptoms of at least one of the following conditions: anxiety, depression, fatigue, insomnia and/or sexual dysfunction.
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- Ongoing regular psychoactive medication only accepted if dosage has been stable during the last 3 months.
- Daily access to the Internet by computer and/or smartphone.
- Ability to use a computer and/or smartphone and the internet.
- No participation on any other interventional study or clinical trial.
Who cannot join
- Age ≤ 18 years;
- Inability to co-operate and give informed consent.
- Breast cancer not histologically or cytologically confirmed.
- History of other malignancy within the last 5 years.
- Metastasized breast cancer.
- Current severe, uncontrolled systemic disease or mental disorder.
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- Absence of clinically significant symptoms.
- Parallel ongoing psychological treatment.
- Ongoing regular psychoactive medication if dosage has been changed during the last 3 months.
- No access to the internet.
- Inability to use a computer and/or smartphone and the internet.
- Parallel ongoing participation in other interventional study or clinical trial.
- Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
No sites are listed yet.
Gerhard Andersson, PhD contact
About this study
Official title: Self-care Programs in Oncology: a Guided Internet-delivered Individually-tailored Acceptance and Commitment Therapy (ACT)-Influenced Cognitive Behavioural Intervention to Improve Psychosocial Outcomes in Breast Cancer Survivors
Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on this field and aiming at improving survivors´ psychosocial needs is scarce and its practical implementation is limited.
Objectives: This study aims at studying BC patients´ and healthcare providers' attitudes towards IDI; exploring BC patients´ unmet support needs and; determining the acceptability, feasibility, efficacy and cost-effectiveness of iACT-BC, a guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention designed to improve psychosocial outcomes in BC survivors when compared to treatment as usual. The primary outcomes in this research are anxiety and depression. Secondary outcomes include psychological flexibility, fatigue, insomnia, Sexual dysfunction (SD) and Health Related Quality of Life.
Read more
Methods: A multimethod research design will be applied and two consecutive studies will be performed. Study 1 will explore participants´ attitudes towards IDI as well as, BC patients' psychosocial unmet needs by adopting an exploratory cross-sectional study design. Study 2 will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm, parallel, open label, multicentre, waiting list randomized controlled trial.
Expected Results: It is anticipated that iACT-BC will show to be an effective and cost-effective program in improving anxiety, depression, psychological flexibility, fatigue, insomnia, SD and HRQoL in BC survivors, as opposing to a waiting list control under treatment as usual. The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in February 2020.
Read the detailed description
Background: Breast Cancer (BC) ranks as the most frequent and lethal cancer among women, in Portugal. However, advances in cancer detection and treatment contributed to a steady and significant increase in survival over the past years, and 5-year age-standardized relative survival is currently estimated to be 83,4%. This increase translates into a high and growing number of BC survivors, with a considerable proportion of these patients experiencing sequelae of treatment and late effects that can occur immediately to several years after primary treatment ends. Anxiety, depression, fear of recurrence, existential related issues, fatigue, pain, physical and cognitive impairment, tailored information needs, and sexual dysfunction have been reported as the most common unmet support care needs experienced by these women. The answer to these unmet support care needs relies, in part, on delivering comprehensive, highly coordinated, patient-centred care. However, operationalizing such care may prove difficult in a context of competing priorities and constrained health and social care budgets. In this context, connected health, particularly internet-delivered interventions, can provide remarkable opportunities in overcoming the aforementioned constraints, as presenting an effective and innovative healthcare delivery model capable of improving care coordination and providing access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on this field and aiming at improving survivors´ psychosocial needs is scarce and its practical implementation is limited.
Objectives: The objectives of this investigation are: studying BC patients´ and healthcare providers' attitudes towards internet-delivered interventions; exploring breast cancer patients´ unmet support care needs and; determining the acceptability, feasibility, effectiveness and cost-effectiveness of iACT-BC, a guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural intervention designed to improve psychosocial outcomes in BC survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC). The primary outcomes in this research are anxiety and depression. Secondary outcomes include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL).
Hypotheses: We hypothesize that participants in the intervention group will have improved anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL, when compared to a WLC.
Methods: A multimethod research design will be applied and two consecutive studies will be performed: Study 1 - Population characterization study and Study 2 - Efficacy and cost-effectiveness study. Study 1 will explore participants´ attitudes towards internet-delivered interventions as well as, BC patients' psychosocial unmet support needs by adopting an exploratory cross-sectional study design. Study 2 will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm, parallel, open label, multicentre, pragmatic, waiting list randomized controlled trial. A Pilot study, mirroring the conditions applied in Study 2 should be performed in order to evaluate the feasibility and acceptability of iACT-BC. Results from this Pilot study should be appraised and inform execution of Study 2
Ethical approval: This study will soon be submitted to evaluation by CNPD and local ethic committees. Authorization to run the study is expected to be received until January 2018.
Expected Results: It is anticipated that iACT-BC will show to be an effective and cost-effective program in improving psychosocial outcomes such as anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL in BC survivors, as opposing to a WLC under TAU. The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in February 2020.
Keywords: Breast Cancer; Survivors; Internet intervention; Psychosocial intervention; Acceptance and Commitment Therapy (ACT); Randomized controlled trial protocol.
- Conditions
- Breast Neoplasm
- Being tested
- iACT-BC
- Keywords
- Breast Cancer, Survivors, Internet intervention, Psychosocial intervention, Acceptance and Commitment Therapy (ACT), Randomized 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.
iACT-BCBehavioural
A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors
| Study group | Role | What they receive |
|---|---|---|
| A - iACT-BC experimental group | Experimental | Not described Receives: Behavioral: iACT-BC |
| B - Waiting list control group | Other | Not described Receives: Behavioral: iACT-BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Patient Health Questionnaire (PHQ-9)
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Anxiety
Generalized Anxiety Disorder Scale (GAD-7)
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary outcomes (6)
Psychological flexibility
Cancer Acceptance and Action Questionnaire (Cancer AAQ)
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Fatigue
Brief Fatigue Inventory (BFI)
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Insomnia
Insomnia Severity Index (ISI)
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Sexual dysfunction
Female Sexual Function Index (FSFI)
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Health related quality of life - generic measure
EORTC QLQC30
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Health related quality of life - breast cancer specific measure
EORTC QLQBR23
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study startFeb 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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 NeoplasmStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Universidade Nova de Lisboa
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275727
- Sponsor's protocol ID
- INNOVBC
- Acronym
- INNOVBC
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendes-Santos C, Weiderpass E, Santana R, Andersson G. A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol. Internet Interv. 2019 Feb 10;17:100236. doi: 10.1016/j.invent.2019.01.004. eCollection 2019 Sep.
PubMed 30949435
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-care Programs in Oncology: a Guided Internet-delivered Individually-tailored Acceptance and Commitment Therapy (ACT)-Influenced Cognitive Behavioural Intervention to Improve Psychosocial Outcomes in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03275727
- Acronym / sponsor ID
- INNOVBC / INNOVBC
- Conditions
- Breast Neoplasm
- Keywords
- Breast Cancer, Survivors, Internet intervention, Psychosocial intervention, Acceptance and Commitment Therapy (ACT), Randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Universidade Nova de Lisboa
- Study start
- Feb 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Sep 2017 (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.
Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on this field and aiming at improving survivors´ psychosocial needs is scarce and its practical implementation is limited.
Objectives: This study aims at studying BC patients´ and healthcare providers' attitudes towards IDI; exploring BC patients´ unmet support needs and; determining the acceptability, feasibility, efficacy and cost-effectiveness of iACT-BC, a guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention designed to improve psychosocial outcomes in BC survivors when compared to treatment as usual. The primary outcomes in this research are anxiety and depression. Secondary outcomes include psychological flexibility, fatigue, insomnia, Sexual dysfunction (SD) and Health Related Quality of Life.
Methods: A multimethod research design will be applied and two consecutive studies will be performed. Study 1 will explore participants´ attitudes towards IDI as well as, BC patients' psychosocial unmet needs by adopting an exploratory cross-sectional study design. Study 2 will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm, parallel, open label, multicentre, waiting list randomized controlled trial.
Expected Results: It is anticipated that iACT-BC will show to be an effective and cost-effective program in improving anxiety, depression, psychological flexibility, fatigue, insomnia, SD and HRQoL in BC survivors, as opposing to a waiting list control under treatment as usual. The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in February 2020.
Detailed description
Background: Breast Cancer (BC) ranks as the most frequent and lethal cancer among women, in Portugal. However, advances in cancer detection and treatment contributed to a steady and significant increase in survival over the past years, and 5-year age-standardized relative survival is currently estimated to be 83,4%. This increase translates into a high and growing number of BC survivors, with a considerable proportion of these patients experiencing sequelae of treatment and late effects that can occur immediately to several years after primary treatment ends. Anxiety, depression, fear of recurrence, existential related issues, fatigue, pain, physical and cognitive impairment, tailored information needs, and sexual dysfunction have been reported as the most common unmet support care needs experienced by these women. The answer to these unmet support care needs relies, in part, on delivering comprehensive, highly coordinated, patient-centred care. However, operationalizing such care may prove difficult in a context of competing priorities and constrained health and social care budgets. In this context, connected health, particularly internet-delivered interventions, can provide remarkable opportunities in overcoming the aforementioned constraints, as presenting an effective and innovative healthcare delivery model capable of improving care coordination and providing access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on this field and aiming at improving survivors´ psychosocial needs is scarce and its practical implementation is limited.
Objectives: The objectives of this investigation are: studying BC patients´ and healthcare providers' attitudes towards internet-delivered interventions; exploring breast cancer patients´ unmet support care needs and; determining the acceptability, feasibility, effectiveness and cost-effectiveness of iACT-BC, a guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural intervention designed to improve psychosocial outcomes in BC survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC). The primary outcomes in this research are anxiety and depression. Secondary outcomes include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL).
Hypotheses: We hypothesize that participants in the intervention group will have improved anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL, when compared to a WLC.
Methods: A multimethod research design will be applied and two consecutive studies will be performed: Study 1 - Population characterization study and Study 2 - Efficacy and cost-effectiveness study. Study 1 will explore participants´ attitudes towards internet-delivered interventions as well as, BC patients' psychosocial unmet support needs by adopting an exploratory cross-sectional study design. Study 2 will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm, parallel, open label, multicentre, pragmatic, waiting list randomized controlled trial. A Pilot study, mirroring the conditions applied in Study 2 should be performed in order to evaluate the feasibility and acceptability of iACT-BC. Results from this Pilot study should be appraised and inform execution of Study 2
Ethical approval: This study will soon be submitted to evaluation by CNPD and local ethic committees. Authorization to run the study is expected to be received until January 2018.
Expected Results: It is anticipated that iACT-BC will show to be an effective and cost-effective program in improving psychosocial outcomes such as anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL in BC survivors, as opposing to a WLC under TAU. The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in February 2020.
Keywords: Breast Cancer; Survivors; Internet intervention; Psychosocial intervention; Acceptance and Commitment Therapy (ACT); Randomized controlled trial protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - iACT-BC experimental group | Experimental | Behavioral: iACT-BC |
| B - Waiting list control group | Other | Behavioral: iACT-BC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent.
- Age ≥ 18 years;
- Ability to read and write in Portuguese.
- History of histologically or cytologically confirmed breast cancer with no evidence of metastatic disease.
- An interval ≥ 6 month from primary adjuvant treatment completion (surgery, chemotherapy and/or radiotherapy), except for hormonal therapy.
Key exclusion criteria (13 listed)
- Age ≤ 18 years;
- Inability to co-operate and give informed consent.
- Breast cancer not histologically or cytologically confirmed.
- History of other malignancy within the last 5 years.
- Metastasized breast cancer.
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 |
|---|---|---|
| iACT-BCA Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors | Behavioural | A - iACT-BC experimental group, B - Waiting list control group |
Primary outcome
Depression
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Patient Health Questionnaire (PHQ-9)
Anxiety
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Generalized Anxiety Disorder Scale (GAD-7)
6 secondary outcomes
Psychological flexibility
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Fatigue
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Insomnia
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Sexual dysfunction
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Health related quality of life - generic measure
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Health related quality of life - breast cancer specific measure
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Derived from this study: PubMed 30949435Mendes-Santos C, Weiderpass E, Santana R, Andersson G. A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol. Internet Interv. 2019 Feb 10;17:100236. doi: 10.1016/j.invent.2019.01.004. eCollection 2019 Sep.
- Individual participant dataSharing planned: No
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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.
Gerhard Andersson, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing iACT-BC in people with Breast Neoplasm, run by Linkoeping University.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina M Santos, MsC (+351917890798, cristina.mendes.santos@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months). The study lists 2 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 NCT03275727, 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 8 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.