Interventions for fatigued palliative cancer patients.

Fatigue in palliative care: Are graded exercise and cognitive behaviour therapy effective treatments and what mediates the treatment response?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28214

Enrollment

219

Registered

2013-01-23

Start date

2012-09-01

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

Severe fatigue

Interventions

1. Graded exercise therapy (GET): Patients assigned to this condition will receive GET in addition to usual care. The GET will consist of weekly sessions of two hours resistance and aerobic training w

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed with locally advanced or metastatic cancer (i.e., breast, colon, prostate, ovarian, renal cell, cervix/endometrial, or bladder cancer, melanoma, or sarcoma); 2. Age 18 or above; 3. Able to speak, read and write Dutch; 4. Being severely fatigued (CIS ≥ 35) for at least two weeks consecutively without known and treatable somatic causes, other than cancer; 5. Scheduled for of palliative systemic treatment.

Exclusion criteria

Exclusion criteria: 1. Contra-indication for exercise (a physical potency of walking six minutes successively is a minimum); 2. Brain metastases; 3. Receiving treatment for a psychiatric disorder; 4. Karnofsky scale < 70.

Design outcomes

Primary

Measure	Time frame
Fatigue severity with subscale fatigue of the Checklist Individual Strength (CIS) ≥ 35 at 3 months. Follow up will be done at 4 months and 6 months.	—

Secondary

Measure	Time frame
1. Quality of life assessed with subscale Global health status of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30 version 3.0) at baseline assessment, 3 months, 4 months, and 6 months; 2. Functional impairments assessed by the total score on the Sickness Impact Profile 7 (SIP7) and the subscales Emotional functioning and Physical functioning of the EORTC QLQ-C30 at baseline assessment, 3 months, 4 months, and 6 months; 3. Fatigue severity will also be assessed with the subscale Fatigue of the EORTC QLQ-C30 version 3.0 at baseline assessment, 3 months, 4 months, and 6 months.	—

Measure

Time frame

1. Quality of life assessed with subscale Global health status of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30 version 3.0) at baseline assessment, 3 months, 4 months, and 6 months; 2. Functional impairments assessed by the total score on the Sickness Impact Profile 7 (SIP7) and the subscales Emotional functioning and Physical functioning of the EORTC QLQ-C30 at baseline assessment, 3 months, 4 months, and 6 months; 3. Fatigue severity will also be assessed with the subscale Fatigue of the EORTC QLQ-C30 version 3.0 at baseline assessment, 3 months, 4 months, and 6 months.

—

Contacts

Public ContactH. Poort

Expert Centre for Chronic Fatigue Radboud University Medical Centre P.O. box 9101

H.Poort@nkcv.umcn.nl+31 (0)24 3610048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)