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A randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU)

A randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU) - Cancer-related fatigue: systematic treatment of physical symptoms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30469
Enrollment
152
Registered
2007-08-08
Start date
2007-10-10
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

cancer-related fatigue

Interventions

Patients randomized in the intervention-arm of the study will participate for 3 months in a complex intervention. The intervention will be conducted by a trained nurse specialist. This nurse special

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a. Histologically or cytologically proven solid malignancy; b. Curative treatment is not possible anymore; c. Treated in the outpatient clinic; d. Presence of fatigue scored as >=4 on a scale of 0 to 10; e. Age >=18 years; f. WHO performance status = 3 months; h. Able to write and speak Dutch; i. Signed informed consent.

Exclusion criteria

Exclusion criteria: a. Concomitant (or within 4 weeks before randomization) administration of any experimental drug; b. Stay in a nursing home; c. Untreated depression or anxiety disorders; d. Severe comorbidity, e.g. heart failure or symptomatic chronic obstructive lung disease e. Cognitive limitations

Design outcomes

Primary

MeasureTime frame
Mean decrease over time in general fatigue measured by Multiple Fatigue Inventory (MFI).

Secondary

MeasureTime frame
Physical fatigue, reduced activity, reduced motivation and mental fatigue measured by MFI; quality of life; daily interference; severity of symptoms; anxiety and depressed mood.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)