Evaluation of intervention strategies to manage fatigue during active treatment and to prevent persistent fatigue after curative treatment for cancer.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23808

Enrollment

300

Registered

2005-09-05

Start date

2005-11-01

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

Patients diagnosed with cancer and who will start treatment with curative intentions. (specified by inclusion criteria)

Interventions

Intervention 1: Minimal intervention: The minimal intervention consists of a booklet with easily understood general information about two components. In two one hour session the research nurse will e

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients just have been diagnosed for breast cancer, colorectal cancer, cervix cancer, uterus cancer, testis cancer, Hodgkin and non-Hodgkin disease; 2. Patients in preparation of receiving therapy with curative intention (chemotherapy, radiotherapy and/or surgery); 3. 18-70 years old; 4. Patients must be able to speak and write Dutch and to fill out the questionnaires independently; 5. Patients have no somatic co-morbidity unrelated to the malignancy, that can co-exist with fatigue.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Fatigue severity will be measured using the Checklist Individual Strength (Vercoulen et al., 1994; Vercoulen et al., 1999). The Checklist Individual Strength is a 20-item questionnaire, designed to measure four aspects of fatigue over the last 14 days, namely: fatigue severity (8 items), concentration (5 items), motivation (4 items) and physical activity (3 items). Each item is scored on a 7-point Likert scale. High scores indicate a high level of fatigue, a high level of concentration problems, low motivation and a low level of activity. Psychometric properties are excellent. A score of 35 or higher on the subscale fatigue severity indicates severe feelings of fatigue. Norm scores of different patients groups and healthy controls are available (Vercoulen et al., 1999, Servaes et al., 2002).	—

Measure

Time frame

Fatigue severity will be measured using the Checklist Individual Strength (Vercoulen et al., 1994; Vercoulen et al., 1999). The Checklist Individual Strength is a 20-item questionnaire, designed to measure four aspects of fatigue over the last 14 days, namely: fatigue severity (8 items), concentration (5 items), motivation (4 items) and physical activity (3 items). Each item is scored on a 7-point Likert scale. High scores indicate a high level of fatigue, a high level of concentration problems, low motivation and a low level of activity. Psychometric properties are excellent. A score of 35 or higher on the subscale fatigue severity indicates severe feelings of fatigue. Norm scores of different patients groups and healthy controls are available (Vercoulen et al., 1999, Servaes et al., 2002).

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Secondary

Measure	Time frame
Psychological distress will be measured by the Symptom Checklist-90 (SCL-90). This 90-item questionnaire consists of the subscales anxiety, agoraphobia, depression, somatisation, obsessive-compulsive behaviour, interpersonal sensitivity, hostility and sleep disturbances (Arindell & Ettema, 1986). Daily observed fatigue will be measured during a two-week period with the Self-Observation List. This is another important assessment instrument that is developed by our research group (Fennis et al., 1990; Bleijenberg & Kuipers, 1994). The SOL has been constructed in order to obtain information about severity and frequency of fatigue and other complaints during a two-week period. Fatigue severity is reported four times a day on a 4-point scale (0-16). During this two-week period physical activity will be measured with the actometer, (Vercoulen et al, 1997). The actometer has the size of a match box and records the number of movements every five minute period. This apparatus has to be worn around the ankle day and night for a consecutive two-weeks. The actometer has been used satisfactory in several previous studies. In addition, patients report their level of activity four times a day in the Self-Observation List. Physical fitness will be measured by a steptest (White et al., 2001). The patients will be asked to walk up and down a flight of nine standard stairs at a reasonable but not fixed pace, for 1 minute. The resting pulse rate will be measured and the pulse rate 30 seconds after completion of the exercise. A measure of physical fitness will be calculated by dividing the number of stairs climbed by the exercise pulse-rate difference. The Beck Depression Inventory for primary care (BDI-pc) will be used to measure depression (Beck et al, 1961; 1997). The primary care version will be used to prevent an overlap between the physical aspects of fatigue with the somatic symptoms of depression. This shortened version of the BDI has seven items and is composed of cogniti	—

Measure

Time frame

Psychological distress will be measured by the Symptom Checklist-90 (SCL-90). This 90-item questionnaire consists of the subscales anxiety, agoraphobia, depression, somatisation, obsessive-compulsive behaviour, interpersonal sensitivity, hostility and sleep disturbances (Arindell & Ettema, 1986). Daily observed fatigue will be measured during a two-week period with the Self-Observation List. This is another important assessment instrument that is developed by our research group (Fennis et al., 1990; Bleijenberg & Kuipers, 1994). The SOL has been constructed in order to obtain information about severity and frequency of fatigue and other complaints during a two-week period. Fatigue severity is reported four times a day on a 4-point scale (0-16). During this two-week period physical activity will be measured with the actometer, (Vercoulen et al, 1997). The actometer has the size of a match box and records the number of movements every five minute period. This apparatus has to be worn around the ankle day and night for a consecutive two-weeks. The actometer has been used satisfactory in several previous studies. In addition, patients report their level of activity four times a day in the Self-Observation List. Physical fitness will be measured by a steptest (White et al., 2001). The patients will be asked to walk up and down a flight of nine standard stairs at a reasonable but not fixed pace, for 1 minute. The resting pulse rate will be measured and the pulse rate 30 seconds after completion of the exercise. A measure of physical fitness will be calculated by dividing the number of stairs climbed by the exercise pulse-rate difference. The Beck Depression Inventory for primary care (BDI-pc) will be used to measure depression (Beck et al, 1961; 1997). The primary care version will be used to prevent an overlap between the physical aspects of fatigue with the somatic symptoms of depression. This shortened version of the BDI has seven items and is composed of cogniti

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Contacts

Public ContactM.M. Goedendorp

University Medical Center St. Radboud, Expert Centre Chronic Fatigue, P.O. Box 9101

M.Goedendorp@nkcv.umcn.nl+31 (0)24 3610030

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)