<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03275727</url>
  </required_header>
  <id_info>
    <org_study_id>INNOVBC</org_study_id>
    <nct_id>NCT03275727</nct_id>
  </id_info>
  <brief_title>A Guided Internet-delivered Individually-tailored ACT-influenced CBT Intervention to Improve Psychosocial Outcomes in Breast Cancer</brief_title>
  <acronym>INNOVBC</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Nova de Lisboa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in&#xD;
      addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy&#xD;
      to improve care coordination and provide access to efficacious, cost-efficient and convenient&#xD;
      survivorship care. Nevertheless, research focusing on this field and aiming at improving&#xD;
      survivors´ psychosocial needs is scarce and its practical implementation is limited.&#xD;
&#xD;
      Objectives: This study aims at studying BC patients´ and healthcare providers' attitudes&#xD;
      towards IDI; exploring BC patients´ unmet support needs and; determining the acceptability,&#xD;
      feasibility, efficacy and cost-effectiveness of iACT-BC, a guided internet-delivered&#xD;
      individually-tailored ACT-influenced cognitive behavioural intervention designed to improve&#xD;
      psychosocial outcomes in BC survivors when compared to treatment as usual. The primary&#xD;
      outcomes in this research are anxiety and depression. Secondary outcomes include&#xD;
      psychological flexibility, fatigue, insomnia, Sexual dysfunction (SD) and Health Related&#xD;
      Quality of Life.&#xD;
&#xD;
      Methods: A multimethod research design will be applied and two consecutive studies will be&#xD;
      performed. Study 1 will explore participants´ attitudes towards IDI as well as, BC patients'&#xD;
      psychosocial unmet needs by adopting an exploratory cross-sectional study design. Study 2&#xD;
      will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by&#xD;
      implementing a two-arm, parallel, open label, multicentre, waiting list randomized controlled&#xD;
      trial.&#xD;
&#xD;
      Expected Results: It is anticipated that iACT-BC will show to be an effective and&#xD;
      cost-effective program in improving anxiety, depression, psychological flexibility, fatigue,&#xD;
      insomnia, SD and HRQoL in BC survivors, as opposing to a waiting list control under treatment&#xD;
      as usual. The results of this research will be published in accordance with CONSORT 2010 and&#xD;
      CONSORT-EHEALTH guidelines and should be available for publication in February 2020.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Breast Cancer (BC) ranks as the most frequent and lethal cancer among women, in&#xD;
      Portugal. However, advances in cancer detection and treatment contributed to a steady and&#xD;
      significant increase in survival over the past years, and 5-year age-standardized relative&#xD;
      survival is currently estimated to be 83,4%. This increase translates into a high and growing&#xD;
      number of BC survivors, with a considerable proportion of these patients experiencing&#xD;
      sequelae of treatment and late effects that can occur immediately to several years after&#xD;
      primary treatment ends. Anxiety, depression, fear of recurrence, existential related issues,&#xD;
      fatigue, pain, physical and cognitive impairment, tailored information needs, and sexual&#xD;
      dysfunction have been reported as the most common unmet support care needs experienced by&#xD;
      these women. The answer to these unmet support care needs relies, in part, on delivering&#xD;
      comprehensive, highly coordinated, patient-centred care. However, operationalizing such care&#xD;
      may prove difficult in a context of competing priorities and constrained health and social&#xD;
      care budgets. In this context, connected health, particularly internet-delivered&#xD;
      interventions, can provide remarkable opportunities in overcoming the aforementioned&#xD;
      constraints, as presenting an effective and innovative healthcare delivery model capable of&#xD;
      improving care coordination and providing access to efficacious, cost-efficient and&#xD;
      convenient survivorship care. Nevertheless, research focusing on this field and aiming at&#xD;
      improving survivors´ psychosocial needs is scarce and its practical implementation is&#xD;
      limited.&#xD;
&#xD;
      Objectives: The objectives of this investigation are: studying BC patients´ and healthcare&#xD;
      providers' attitudes towards internet-delivered interventions; exploring breast cancer&#xD;
      patients´ unmet support care needs and; determining the acceptability, feasibility,&#xD;
      effectiveness and cost-effectiveness of iACT-BC, a guided internet-delivered&#xD;
      individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive&#xD;
      behavioural intervention designed to improve psychosocial outcomes in BC survivors when&#xD;
      compared to treatment as usual (TAU) in a waiting list control group (WLC). The primary&#xD;
      outcomes in this research are anxiety and depression. Secondary outcomes include&#xD;
      psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality&#xD;
      of Life (HRQoL).&#xD;
&#xD;
      Hypotheses: We hypothesize that participants in the intervention group will have improved&#xD;
      anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and&#xD;
      HRQoL, when compared to a WLC.&#xD;
&#xD;
      Methods: A multimethod research design will be applied and two consecutive studies will be&#xD;
      performed: Study 1 - Population characterization study and Study 2 - Efficacy and&#xD;
      cost-effectiveness study. Study 1 will explore participants´ attitudes towards&#xD;
      internet-delivered interventions as well as, BC patients' psychosocial unmet support needs by&#xD;
      adopting an exploratory cross-sectional study design. Study 2 will investigate the&#xD;
      effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm,&#xD;
      parallel, open label, multicentre, pragmatic, waiting list randomized controlled trial. A&#xD;
      Pilot study, mirroring the conditions applied in Study 2 should be performed in order to&#xD;
      evaluate the feasibility and acceptability of iACT-BC. Results from this Pilot study should&#xD;
      be appraised and inform execution of Study 2&#xD;
&#xD;
      Ethical approval: This study will soon be submitted to evaluation by CNPD and local ethic&#xD;
      committees. Authorization to run the study is expected to be received until January 2018.&#xD;
&#xD;
      Expected Results: It is anticipated that iACT-BC will show to be an effective and&#xD;
      cost-effective program in improving psychosocial outcomes such as anxiety, depression,&#xD;
      psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL in BC survivors,&#xD;
      as opposing to a WLC under TAU. The results of this research will be published in accordance&#xD;
      with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in&#xD;
      February 2020.&#xD;
&#xD;
      Keywords: Breast Cancer; Survivors; Internet intervention; Psychosocial intervention;&#xD;
      Acceptance and Commitment Therapy (ACT); Randomized controlled trial protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Patient Health Questionnaire (PHQ-9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Generalized Anxiety Disorder Scale (GAD-7)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological flexibility</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Cancer Acceptance and Action Questionnaire (Cancer AAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Brief Fatigue Inventory (BFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Insomnia Severity Index (ISI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual dysfunction</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Female Sexual Function Index (FSFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life - generic measure</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>EORTC QLQC30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life - breast cancer specific measure</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>EORTC QLQBR23</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participants' attitudes towards internet interventions</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Attitudes towards internet interventions survey (ATTIS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Breast cancer patients' unmet support needs</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Supportive Care Needs Survey Questionnaire (SCNS-SF34)</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention cost-effectiveness</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>Questionnaire on Medical consumption and Productivity losses associated with Psychiatric Illness (TIC-P)</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention cost-utility</measure>
    <time_frame>Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months</time_frame>
    <description>EuroQol EQ-5D-5L</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>A - iACT-BC experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B - Waiting list control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iACT-BC</intervention_name>
    <description>A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors</description>
    <arm_group_label>A - iACT-BC experimental group</arm_group_label>
    <arm_group_label>B - Waiting list control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Ability to read and write in Portuguese.&#xD;
&#xD;
          -  History of histologically or cytologically confirmed breast cancer with no evidence of&#xD;
             metastatic disease.&#xD;
&#xD;
          -  An interval ≥ 6 month from primary adjuvant treatment completion (surgery,&#xD;
             chemotherapy and/or radiotherapy), except for hormonal therapy.&#xD;
&#xD;
          -  Clinically significant symptoms of at least one of the following conditions: anxiety,&#xD;
             depression, fatigue, insomnia and/or sexual dysfunction.&#xD;
&#xD;
          -  Ongoing regular psychoactive medication only accepted if dosage has been stable during&#xD;
             the last 3 months.&#xD;
&#xD;
          -  Daily access to the Internet by computer and/or smartphone.&#xD;
&#xD;
          -  Ability to use a computer and/or smartphone and the internet.&#xD;
&#xD;
          -  No participation on any other interventional study or clinical trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 18 years;&#xD;
&#xD;
          -  Inability to co-operate and give informed consent.&#xD;
&#xD;
          -  Breast cancer not histologically or cytologically confirmed.&#xD;
&#xD;
          -  History of other malignancy within the last 5 years.&#xD;
&#xD;
          -  Metastasized breast cancer.&#xD;
&#xD;
          -  Current severe, uncontrolled systemic disease or mental disorder.&#xD;
&#xD;
          -  Absence of clinically significant symptoms.&#xD;
&#xD;
          -  Parallel ongoing psychological treatment.&#xD;
&#xD;
          -  Ongoing regular psychoactive medication if dosage has been changed during the last 3&#xD;
             months.&#xD;
&#xD;
          -  No access to the internet.&#xD;
&#xD;
          -  Inability to use a computer and/or smartphone and the internet.&#xD;
&#xD;
          -  Parallel ongoing participation in other interventional study or clinical trial.&#xD;
&#xD;
          -  Assessment by the investigator to be unable or unwilling to comply with the&#xD;
             requirements of the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female BC survivors</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cristina M Santos, MsC</last_name>
    <phone>+351917890798</phone>
    <email>cristina.mendes.santos@liu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gerhard Andersson, PhD</last_name>
    <email>gerhard.andersson@liu.se</email>
  </overall_contact_backup>
  <link>
    <url>https://innovbc.iterapi.se</url>
    <description>Study website</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Gerhard Andersson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Survivors</keyword>
  <keyword>Internet intervention</keyword>
  <keyword>Psychosocial intervention</keyword>
  <keyword>Acceptance and Commitment Therapy (ACT)</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03275727
org study id: INNOVBC
nct id: NCT03275727
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Depression
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Patient Health Questionnaire (PHQ-9)
measure: Anxiety
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Generalized Anxiety Disorder Scale (GAD-7)
measure: Psychological flexibility
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Cancer Acceptance and Action Questionnaire (Cancer AAQ)
measure: Fatigue
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Brief Fatigue Inventory (BFI)
measure: Insomnia
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Insomnia Severity Index (ISI)
measure: Sexual dysfunction
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Female Sexual Function Index (FSFI)
measure: 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
description: EORTC QLQC30
measure: 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
description: EORTC QLQBR23
measure: Participants' attitudes towards internet interventions
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Attitudes towards internet interventions survey (ATTIS)
measure: Breast cancer patients' unmet support needs
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Supportive Care Needs Survey Questionnaire (SCNS-SF34)
measure: Intervention cost-effectiveness
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: Questionnaire on Medical consumption and Productivity losses associated with Psychiatric Illness (TIC-P)
measure: Intervention cost-utility
time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
description: EuroQol EQ-5D-5L
arm group label: A - iACT-BC experimental group
arm group type: Experimental
arm group label: B - Waiting list control group
arm group type: Other
intervention type: Behavioral
intervention name: iACT-BC
description: A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors
arm group label: A - iACT-BC experimental group
arm group label: B - Waiting list control group
criteria: 
gender: Female
gender based: Yes
gender description: Only female BC survivors
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristina M Santos, MsC
phone: +351917890798
email: cristina.mendes.santos@liu.se
last name: Gerhard Andersson, PhD
email: gerhard.andersson@liu.se
url: https://innovbc.iterapi.se
description: Study website
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Gerhard Andersson
investigator title: Professor
mesh term: Breast Neoplasms
sharing ipd: No