Reducing Cancer-Related Fatigue: Untire App as an Evidence-Based mHealth Solution

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20482

Enrollment

6000

Registered

2017-11-29

Start date

2018-01-18

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Cancer related fatigue (Kankergerelateerde vermoeidheid)

Interventions

The Tired of Cancer app is developed by the Tired of Cancer BV, based on years of academic experiences in the field of psycho-oncology within the Helen Dowling Institute (The Netherlands). The app is

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • 18 years and older; • was/is diagnosed with cancer; • has a smartphone. • experiences persistent fatigue at moderate or severe level; an average composite score (items 1, 2 and 3) of ≥3 on the Fatigue Symptom Inventory.

Exclusion criteria

Exclusion criteria: If participants will answer the following statement and question with “yes”, they are not perceived eligible to participate: • I receive treatment for, take medication for or have a diagnosis of a mental disorder (major depression, anxiety disorder, psychotic disorder or addiction). • Do you have a diagnosis of chronic fatigue syndrome (CF)/myalgic encephalomyelitis (ME) or fibromyalgia (FM)?

Design outcomes

Primary

Measure	Time frame
Change in cancer related fatigue (CRF) from baseline to 12 weeks, assessed with the self-report questionnaire Fatigue Symptom Inventory (FSI).	—

Secondary

Measure	Time frame
- Change in overall quality of life (QoL) from baseline to 12 weeks, assessed with the 1-item on quality of life in the EORTC QLQ-C30 questionnaire. - Insight in usage of the application using log data (automatically stored data about the assessments and activities that users complete). Patterns of usage and most often performed activities will be explored and related to CRF and QoL. - Explore whether domains targeted within the app mediate the relation with users’ outcomes of CRF or QoL. - Moderating factors on CRF and QoL will be explored.	—

Measure

Time frame

- Change in overall quality of life (QoL) from baseline to 12 weeks, assessed with the 1-item on quality of life in the EORTC QLQ-C30 questionnaire. - Insight in usage of the application using log data (automatically stored data about the assessments and activities that users complete). Patterns of usage and most often performed activities will be explored and related to CRF and QoL. - Explore whether domains targeted within the app mediate the relation with users’ outcomes of CRF or QoL. - Moderating factors on CRF and QoL will be explored.

—

Contacts

Public ContactAnne Looijmans

POB 30.001

a.looijmans@umcg.nl050-3616613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)