Longitudinal Investigation of Cancer-related Fatigue
- Conditions
- Cancer-related Fatigue
- Registration Number
- NCT03211273
- Lead Sponsor
- German Cancer Research Center
- Brief Summary
In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and extensively surveyed over five years on factors that are associated with fatigue.
- Detailed Description
The LIFT study aims to comprehensively investigate characteristics, determinants, and long-term course of fatigue. In addition, information shall be gained on the current state of fatigue treatment and care in Germany and on the needs of affected patients.
Data will be collected by mailed or online questionnaires at 6, 9, and 12 months as well as 2, 3, 4 and 5 years post-diagnosis from 2000 cancer patients. Besides questionnaires on socio-demographic, clinical and patient reported outcomes, saliva samples will be collected in order to gain new insights into biological mechanisms. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.
The results of the LIFT study aim to contribute to an improved, evidence-based and individualized treatment to avoid and ease cancer-related fatigue and will further promote patient-oriented offers and treatments.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ≥ 18 years of age
- Diagnosed with a primary tumor of breast, ovarian, or colon cancer
- Time since first diagnosis is 4 - 6 months
- Having received or currently receiving at least one of the following treatments: surgery, chemotherapy, radiotherapy, hormone therapy, or immune therapy.
- Able to understand and follow the study protocol.
• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact of fatigue from diagnosis to 1 year post-diagnosis assessed by the Brief Fatigue Inventory (BFI)
Fatigue severity from diagnosis to 1 year post-diagnosis assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
State of fatigue management from diagnosis to 1 year post-diagnosis Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue
- Secondary Outcome Measures
Name Time Method Quality of life functions and symptoms 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed by EORTC QLQ-C30
Body mass index 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis calculated from weight and height
Sleep problems 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed by Pittsburgh Sleep Quality Index (PSQI)
Total physical activity 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed by a questionnaire regarding walking, cycling, and exercise behavior
Depression 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed by Patient Health Questionnaire (PHQ-9)
Diurnal cortisol rhythm 1 year post-diagnosis assessed in saliva
Return to work 6, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed by a questions regarding occupational issues
Hot flashes 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed only for women
Anxiety 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)