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Tired of being fatigued? Extending evidence-based treatment options for fatigued breast cancer survivors using the internet

Tired of being fatigued? Extending evidence-based treatment options for fatigued breast cancer survivors using the internet - CHANGE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38873
Enrollment
132
Registered
2013-06-20
Start date
2014-01-24
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer breast carcinoma

Interventions

Internet therapy: Fatigued breast cancer survivors will receive internet therapy
a web-based version of the face-to-face CBT protocol for postcancer fatigue, with self-guidance instructions. Patients will be guided through the treatment modules with the help of assignments and i

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female. - Treated for breast cancer with curative intent, and finished primary cancer treatment at least three months previously. Survivors who currently receive hormone therapy are also eligible. - Disease-free at entry of the study, as defined by the absence of somatic disease activity parameters. - Age between 18 and 65. - Able to speak, read, and write Dutch. - Being severely fatigued (scoring 35 or higher on the subscale fatigue severity of the CIS). - Having access to a computer with Internet.

Exclusion criteria

Exclusion criteria: A potential subject will be excluded from participation in this study if: - A somatic co-morbidity is present that can explain the fatigue. - A subject suffers from a depressive disorder. - A subject receives current psychological treatment for a psychiatric disorder. - A subject currently follows a CBT program for fatigue.

Design outcomes

Primary

MeasureTime frame
Main endpoint is fatigue severity (primary outcome measure) at T1.

Secondary

MeasureTime frame
Secondary outcome measures are quality of life, psychological distress, and functional impairments at T1.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)