Cancer-related Fatigue
Conditions
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.
Interventions
None listed
Sponsors
University Hospital Heidelberg
German Cancer Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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.
Exclusion criteria
• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Impact of fatigue | from diagnosis to 1 year post-diagnosis | assessed by the Brief Fatigue Inventory (BFI) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | calculated from weight and height |
| 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 |
| Diurnal cortisol rhythm | 1 year post-diagnosis | assessed in saliva |
| Quality of life functions and symptoms | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | assessed by EORTC QLQ-C30 |
| 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) |
| Return to work | 6, 12 months and 2, 3, 4, and 5 years post-diagnosis | assessed by a questions regarding occupational issues |
| Sleep problems | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | assessed by Pittsburgh Sleep Quality Index (PSQI) |
| Depression | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | assessed by Patient Health Questionnaire (PHQ-9) |
Outcome results
None listed