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Web-based Screening and Tailored Support (ENCOURAGE)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Web-based screening and tailored support
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, psychosocial, website, empowerment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult female breast cancer patients (aged ≥ 18 years of age).
  • Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer
  • Ability to comprehend Dutch (both reading and writing).
  • Access to internet (e.g. at home, via family or friends)
  • Informed consent provided

Exclusion Criteria:

• Chemotherapy treatment with palliative intent or recurrent breast cancer

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web-based screening and tailored support

Standard care

Arm Description

A personalized website (username/password) will become available to patients assigned to the intervention arm for 12 subsequent weeks. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive digital feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, (self)help options and possibilities for referral to professional care. Contact information of one of the investigators will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call.

Patients assigned to standard convalescent care will receive the usual follow-up care delivered by their treating oncologists. Patients will be referred to psychosocial or allied care by their oncologist and/or oncology nurse if certain physical and/or psychosocial problems require more in-depth professional care

Outcomes

Primary Outcome Measures

Change from 6 to 12 weeks follow-up in optimism and control over the future
Patients' optimism and control over the future will be measured by the subscale 'increased optimism and control over the future' of the 'Constructs Empowering Outcomes Questionnaire'. The subscale 'optimism and control over the future' represents a single concept/outcome measure. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.

Secondary Outcome Measures

Change from 6 to 12 weeks follow-up in knowledge level
Patient knowledge level will be measured by the subscale 'being better informed' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Change from 6 weeks to 12 weeks follow-up in acceptance of problems
Patients' acceptance of their problems will be measured by the subscale 'improved acceptance of the illness' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Change from baseline to 12 weeks follow-up in quality of life
Cancer-specific quality of life will be measured by the EORTC QLQ-C30 (version 3.0) questionnaire.
Change from baseline to 12 weeks follow-up in psychological distress
Psychological distress will be measured by the Dutch Distress Thermometer and Problem List.

Full Information

First Posted
April 9, 2013
Last Updated
February 2, 2015
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01834521
Brief Title
Web-based Screening and Tailored Support
Acronym
ENCOURAGE
Official Title
Web-based Screening and Tailored Support for Breast Cancer Patients at the Onset of the Survivorship Phase
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, psychosocial, website, empowerment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based screening and tailored support
Arm Type
Experimental
Arm Description
A personalized website (username/password) will become available to patients assigned to the intervention arm for 12 subsequent weeks. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive digital feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, (self)help options and possibilities for referral to professional care. Contact information of one of the investigators will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients assigned to standard convalescent care will receive the usual follow-up care delivered by their treating oncologists. Patients will be referred to psychosocial or allied care by their oncologist and/or oncology nurse if certain physical and/or psychosocial problems require more in-depth professional care
Intervention Type
Other
Intervention Name(s)
Web-based screening and tailored support
Primary Outcome Measure Information:
Title
Change from 6 to 12 weeks follow-up in optimism and control over the future
Description
Patients' optimism and control over the future will be measured by the subscale 'increased optimism and control over the future' of the 'Constructs Empowering Outcomes Questionnaire'. The subscale 'optimism and control over the future' represents a single concept/outcome measure. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Time Frame
6 and 12 weeks
Secondary Outcome Measure Information:
Title
Change from 6 to 12 weeks follow-up in knowledge level
Description
Patient knowledge level will be measured by the subscale 'being better informed' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Time Frame
6 and 12 weeks
Title
Change from 6 weeks to 12 weeks follow-up in acceptance of problems
Description
Patients' acceptance of their problems will be measured by the subscale 'improved acceptance of the illness' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.
Time Frame
6 and 12 weeks
Title
Change from baseline to 12 weeks follow-up in quality of life
Description
Cancer-specific quality of life will be measured by the EORTC QLQ-C30 (version 3.0) questionnaire.
Time Frame
Baseline and 12 weeks follow-up
Title
Change from baseline to 12 weeks follow-up in psychological distress
Description
Psychological distress will be measured by the Dutch Distress Thermometer and Problem List.
Time Frame
Baseline and 12 weeks follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult female breast cancer patients (aged ≥ 18 years of age). Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer Ability to comprehend Dutch (both reading and writing). Access to internet (e.g. at home, via family or friends) Informed consent provided Exclusion Criteria: • Chemotherapy treatment with palliative intent or recurrent breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.K.L. Reyners, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Web-based Screening and Tailored Support

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