A Guided Internet-delivered Individually-tailored ACT-influenced CBT Intervention to Improve Psychosocial Outcomes in Breast Cancer

NCT03275727 | Unknown Phase 2

• 1 other identifier: INNOVBC
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Breast Neoplasm

Keywords

Breast Cancer; Survivors; Internet intervention; Psychosocial intervention; Acceptance and Commitment Therapy (ACT); Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Depression

  Patient Health Questionnaire (PHQ-9)

  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)

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

Secondary Outcomes (6)

• Psychological flexibility

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

• Fatigue

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

• Insomnia

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

• Sexual dysfunction

  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

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

Other Outcomes (4)

• Participants' attitudes towards internet interventions

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

• Breast cancer patients' unmet support needs

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

• Intervention cost-effectiveness

  Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

Study Arms (2)

A - iACT-BC experimental group

EXPERIMENTAL

Behavioral: iACT-BC

B - Waiting list control group

OTHER

Behavioral: iACT-BC

Interventions

iACT-BC BEHAVIORAL

A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors

A - iACT-BC experimental group; B - Waiting list control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female BC survivors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Linkoeping University: lead
• Universidade Nova de Lisboa: collaborator

Related Publications (1)

• 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.

  PMID: 30949435 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Cristina M Santos, MsC

CONTACT

+351917890798; cristina.mendes.santos@liu.se

Gerhard Andersson, PhD

CONTACT

gerhard.andersson@liu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 8, 2017
• Study Start: February 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share