Longitudinal Investigation of Cancer-related Fatigue

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)

Conditions
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Cancer-related Fatigue

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient cohort<br>Newly diagnosed breast, ovarian or colon cancer patients recruited 6 months post-diagnosis and followed up to 5 years post-diagnosis. No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue severity | assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire) | from diagnosis to 1 year post-diagnosis | 
| Impact of fatigue | assessed by the Brief Fatigue Inventory (BFI) | from diagnosis to 1 year post-diagnosis | 
| State of fatigue management | Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue | from diagnosis to 1 year post-diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life functions and symptoms | assessed by EORTC QLQ-C30 | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Sleep problems | assessed by Pittsburgh Sleep Quality Index (PSQI) | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Depression | assessed by Patient Health Questionnaire (PHQ-9) | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Body mass index | calculated from weight and height | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Total physical activity | assessed by a questionnaire regarding walking, cycling, and exercise behavior | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Diurnal cortisol rhythm | assessed in saliva | 1 year post-diagnosis | 
| Return to work | assessed by a questions regarding occupational issues | 6, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Hot flashes | assessed only for women | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis | 
| Anxiety | assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7) | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |