Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)

Study Overview
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Brief Summary
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The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding cancer-related fatigue from the institutional, professionals' and patients' perspective.

Detailed Description
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The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding fatigue from the institutional, professionals', and patients' perspective. With a multimodal approach including a comprehensive assessment of fatigue management and support offered by different institutions (uncertified hospitals, uncertified oncological practices, counselling units, certified cancer centers; n=350), a survey and qualitative interviews among practicing physicians (Niedergelassene Ärzte), hospital physicians, practicing psychotherapists with psycho-oncological focus, psycho-oncologists at hospitals, nurses at certified cancer centers and nurses at other hospitals (n=420), and a longitudinal clinical study among cancer patients (n=1400) as well as two focus groups with patient representatives (each n=6), the characteristics, patterns, and potential effects or shortcomings of the current fatigue management will be investigated. Furthermore, factors associated with patients' and health care professionals' knowledge about fatigue will be examined. Concerning the longitudinal clinical study assessing the patients' perspective, online or paper-based questionnaires on socio-demographic, clinical and patient reported outcomes will be sent to the patients 6,9,12 and 24 months after diagnosis. 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 project shall provide a basis to identify and overcome shortcomings in the actual fatigue management in Germany, and, to eventually ameliorate this severe burden in cancer patients and survivors.

Official Title
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Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)

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 Newly diagnosed with a primary tumor of one of the following malignant neoplasms: colon (C18), rectum (C19-20), liver (C22), pancreas (C25), lung (C33-34), malignant melanoma (C43), breast (C50, only female), cervix (C53), endometrium (C54.1), ovaries (C56), prostate (C61), kidney (C64), bladder (C67), thyroid gland (C73), non-Hodgkin lymphoma (C82-88), leukemia (C91-C95) Having received or receiving at enrolment at least one of the following treatments: chemotherapy, radiotherapy, hormone therapy, targeted or immune therapy Able to understand and follow the study protocol Exclusion Criteria: Carcinoma in situ Any additional malignant or unclear neoplasm before or since time of diagnosis of the considered primary tumor, except unspecified neoplasm of skin (C44)

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 patients with colon, rectum, liver, pancreas or lung cancer, malignant melanoma, breast or other gynecological cancers, prostate, kidney, bladder or thyroid gland cancer, non-Hodgkin lymphoma or leukemia recruited approximately 6 months after diagnosis and followed up to 2 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). The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much) with higher scores meaning a higher level of fatigue. | 6 months after diagnosis to 2 years post-diagnosis | 
| Impact of fatigue | assessed by the Brief Fatigue Inventory (BFI). The BFI consists of an 11-point numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine) with higher scores signifying higher intensity and impairment. | 6 months after diagnosis to 2 years post-diagnosis | 
| State of fatigue management | Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue. | 6 months after diagnosis to 2 years post-diagnosis | 
| Knowledge, attitudes and beliefs regarding cancer-related fatigue | Questionnaire assessing knowledge, attitudes and beliefs regarding cancer-related fatigue. The knowledge score consists of fatigue-related statements that should be rated as either right, wrong, or dont know. The attitudes scale is composed of statements that should be rated on a 4-point likert scale. Higher scores indicate a greater agreement to the particular statement. | 6 months after diagnosis to 2 years post-diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life functions and symptoms | assessed by EORTC QLQ-C30 and 5 additional items derived according to the EORTC scoring manual assessing symptoms of fever, hot flashes, night sweat, polyneuropathy and distress of dependents caused by the diagnosis are added. The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). A higher score corresponds to a higher level of symptoms/problems. | 6 months after diagnosis to 2 years post-diagnosis | 
| Sleep problems | assessed by Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of open and closed questions regarding characteristics of sleep and sleep quality. Some items are rated on a 4-point likert scale with higher scores meaning more sleep problems. | 6 months after diagnosis to 2 years post-diagnosis | 
| Depression | assessed by Patient Health Questionnaire (PHQ-9). The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score is calculated, with higher scores meaning a higher level of depressive symptoms. | 6 months after diagnosis to 24 months post-diagnosis | 
| Body mass index | calculated from weight and height | 6 months, 12 months and 24 months post-diagnosis | 
| Total physical activity | assessed by a questionnaire regarding walking, cycling and exercise behavior | 6 months, 12 months and 24 months post-diagnosis | 
| Return to work | assessed by questions regarding occupational issues | 6 months, 12 months and 24 months post-diagnosis | 
| Anxiety | assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7). The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score (ranging from 0 to 21) is calculated, with higher scores meaning a higher level of symptomatology. | assessed 6 months after diagnosis to 24 months after diagnosis | 
| Supportive Care Needs | assessed by the Supportive Care Needs Survey (SCNS-SF-34). The scale ranges from 1 (not applicable) to 5 (high need) with higher scores meaning a higher need of support. | assessed at t2 9 months post-diagnosis | 
| Social Support | assessed by the Illness-specific Social Support Scale (ISSS, German Version) among cancer patients. The 8 items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Sum scores for the items 1,3,6 and 8 (positive support) as well as for the items 2,4,5 and 7 (detrimental interaction) are calculated with higher scores meaning higher levels of positive support and detrimental interaction respectively. | at t1 (6 months post-diagnosis) and t3 (12 months post-diagnosis) | 
| Loneliness | assessed by three items of the University of California, Los Angeles (UCLA)-loneliness-scale. The response categories are 1 (hardly ever), 2 (some of the time) and 3(often). A sum score is calculated with higher scores meaning a higher level of loneliness. | at t1 (6 months post-diagnosis) and t4 (24 months post-diagnosis) | 
| Resilience | assessed by the Brief Resilience Scale (BRS). The six items are rated on a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). After reversing the coding of inverted items 2,4 and 6, the mean of the six items is calculated with higher scores meaning a higher level of resilience. | assessed at t1 6 months post-diagnosis | 
| Patient Activation | assessed by the Patient Activation Measure (PAM-13). Patients are supposed to rate their level of agreement to 13 statements on a 4-point-scale. A higher score corresponds to a higher level of patient activation. | at t2 (9 months post-diagnosis) | 
| Posttraumatic growth | assessed by Posttraumatic Growth Inventory (PTGI). The items are rated on a 6-point Likert scale ranging from 1 (not at all) to 6 (very strongly) with higher scores indicating a higher level of posttraumatic growth. | at t4 (24 months post-diagnosis) |