Web-based Screening and Tailored Support

NCT01834521 | Completed

• 2 other identifiers: ENCOURAGE2-2012NL41408.042.12
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; psychosocial; website; empowerment

Outcome Measures

Primary Outcomes (1)

• 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.

  6 and 12 weeks

Secondary Outcomes (4)

• Change from 6 to 12 weeks follow-up in knowledge level

  6 and 12 weeks

• Change from 6 weeks to 12 weeks follow-up in acceptance of problems

  6 and 12 weeks

• Change from baseline to 12 weeks follow-up in quality of life

  Baseline and 12 weeks follow-up

• Change from baseline to 12 weeks follow-up in psychological distress

  Baseline and 12 weeks follow-up

Study Arms (2)

Web-based screening and tailored support

EXPERIMENTAL

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.

Other: Web-based screening and tailored support

Standard care

NO INTERVENTION

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

Interventions

Web-based screening and tailored support OTHER

Web-based screening and tailored support

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chemotherapy treatment with palliative intent or recurrent breast cancer

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms; Empowerment

Condition Hierarchy (Ancestors)

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

Study Officials

• A.K.L. Reyners, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 18, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (1)