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

Cancer-related Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921644
• Other study ID #: LIFT project
• Status: Recruiting
• Start date: August 20, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2022
• Source: German Cancer Research Center
• Contact: Marlena Milzer
• Phone: +49 6221/42 2207
• Email: marlena.milzer[@]dkfz-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: February 28, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (4)

Lead Sponsor	Collaborator
German Cancer Research Center	Baden-Württemberg Cancer Registry, German Research Foundation, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Body mass index	calculated from weight and height	6 months, 12 months and 24 months post-diagnosis
Secondary	Total physical activity	assessed by a questionnaire regarding walking, cycling and exercise behavior	6 months, 12 months and 24 months post-diagnosis
Secondary	Return to work	assessed by questions regarding occupational issues	6 months, 12 months and 24 months post-diagnosis
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)