cancer oncology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - adults older than 18 years - primary treatment with curative intent was finished less than 12 months ago (adjuvant hormonal or is allowed) - types of cancer: breast, prostate, lymphoma, gynecological, colorectal - complex adverse effects of cancer or cancer treatment as determined using the Lastmeter
Exclusion criteria
Exclusion criteria: - serious diseases that might hamper a patient*s capacity to carry out intensive exercise (e.g. severe heart failure: New York Heart Assaciation (NYHA) criteria class 3 & 4 and COPD Gold 3 & 4) - severe psychopathology - patients who are undergoing primary or palliative cancer treatment - inability to understand the Dutch language - patients who finished their cancer treatment more than 12 months ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life Cancer-specific quality of life will be assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 is a reliable and valid instrument that has been used in many studies evaluating clinical and psychosocial interventions in cancer patients. The 30-item EORTC QLQ-C30 incorporates a global quality of life scale and five functional scales, namely physical functioning, social functioning, role functioning, emotional functioning, and cognitive functioning; and three symptom scales, namely fatigue, pain, and nausea and vomiting. In this study, we will report the results of the global scale, the functional scales, and one symptom scale (i.e. fatigue) since these are the scales most relevant for participants who have already completed primary treatment for cancer. After applying a linear transformation procedure according to the EORTC QLQ C-30 manual, the scores of the scales range from 0 to 100. A higher score represents a higher quality of life on the global and functional scales, and a higher level of fatigue. In a previous study differences of at least ten points are classified as a minimum clinically meaningful change. | — |
Secondary
| Measure | Time frame |
|---|---|
| Costs During the study period (12 months), all participants will fill out questionnaires to assess their healthcare resource use, work status and productivity losses. Data on health care costs, patient and family costs will be collected using the Medical Consumption Questionnaire (iMCQ) on a 3-monthly basis. Health care costs include the costs of oncological care, general practice care, paramedic care, additional visits to other health care providers, prescription of medication, professional home care and hospitalization. Patient and family costs include out-of-pocket expenses such as travel expenses, over-the-counter medication, and costs for paid and unpaid help. Units resource use (GP visits, hospital days, etc.) will be multiplied by their appropriate integral cost prices. The EuroQuol-5D-5L (EQ-5D-5L) will be used to calculate quality-adjusted life years (QALYs) and consists of the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises five health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension comprises five levels (no problems, some problems, moderate problems, severe problems and extreme problems). The EQ VAS records the respondents* self-rated health status on a vertical graduated (0-100) visual analogue scale. An economic evaluation regarding work/work loss and health care use will be conducted as a cost-utility analysis for health-related quality of life (and changes therein) as assessed using the EQ-5D. Indirect non-medical cost data related to production losses through work loss days and work cutback days will be sampled with the Productivity Costs Questionnaire (iPCQ) for the measurement (and valuation) of productivity costs. It has been tested in several Dutch samples of patients and workers. The modular questionnaire covers all relevant aspects of the relationship between health and productivity, including absence from work, compensation mechani | — |
Countries
Netherlands