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The effectiveness and working mechanisms of two different e-health interventions for people suffering from chronic fatigue after cancer.

The effectiveness and working mechanisms of two different e-health interventions for people suffering from chronic fatigue after cancer. - E-health interventions for CCRF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44111
Enrollment
330
Registered
2012-11-19
Start date
2013-05-06
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

chronische vermoeidheid na kanker chronic cancer related fatigue fatigue after cancer

Interventions

AAF: Patients will first receive an e-mail from their personal physiotherapist containing information about physical activity and CCRF and the intervention. They will be asked about the kind of act

Sponsors

Roessingh Research and Development i.s.m. Helen Dowling Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - CIS-fatigue score of 35 or higher on the fatigue severity subscale of the Checklist Individual Strength (CIS) (administered via website) - Patient has been suffering from severe fatigue for at least three months (self-report) - Completion of treatment for cancer at least three months ago (checked during referral). Treatment is defined as surgery, chemotherapy, radiation / radiotherapy, immunotherapy, and/or bone marrow transplant. Hormonal therapy, the use of anti-inflammatories and monitoring visits are not considered as treatment - Disease-free, as defined by the absence of cancer activity parameters (checked during referral) - Age older than 19 years (self-report) - Age at disease onset minimal 18 years (self-report) - Capable of reading and writing Dutch language (self-report) These criteria are based on self-report unless stated otherwise.

Exclusion criteria

Exclusion criteria: - Current or former severe psychiatric morbidity as major depression, psychoses or schizophrenia, or current addiction (checked during referral). Exception: Mild depression is no exclusion criterion. Any addiction in the past that has long been under control is no exclusion criterion. If a patient scores above cutoff score on the HADS (see paragraph 6.1.2) at the intake questionnaire, which is an indication for depression, the patient will be contacted by a psychologist of the Helen Dowling Institute to exclude whether the participant suffers from major depression. - Pregnancy (self-report). - Being dependent on a wheelchair for daily activity (self-report).

Design outcomes

Primary

MeasureTime frame
Primary outcome measure - Fatigue will be assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS). T2 (and not combined with T2') will be the main endpoint of this study. Mediating factors - Physical activity: accelerometer - Level of Mindfulness: Freiburg Mindfulness Inventory, short form (FMI-S) - Sense of control over symptoms (SES) - Subjective sleep quality: Subjective Sleep Quality Scale (SSQS) - Credibility and expectancy: Credibility/Expectancy Questionnaire (CEQ) - Working alliance: working alliance inventory, short form (WAI-S)

Secondary

MeasureTime frame
Secondary outcome measures - Mental health will be measured by two instruments, namely 1) Positive and negative affect (PANAS), and 2) Psychological distress (HADS). - Work ability (return to work, hours work per week), Trimbos/iMTA questionnaire for Costs associated with psychiatric Illness (TIC-P)) - Self perceived ability to work: Work Ability Index (WI) Other study parameters (Attachment 4 "Study schedule supplement" and paragraph 6.1.3 of the protocol offer more detailed information on this topic.) - sex - age - work status - subjective physical activity - causal attributions - duration of fatigue - social support - experience with mindfulness-exercise - perceived probability of and anxiety over cancer recurrence - perceived life threat of cancer - desirable responding - Degree of limitation in physical activity by pain - perceived effect of intervention - Self-efficacy over physical activity - Important life events during study period - psychological help during study period.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)