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Longitudinal Investigation of Cancer-related Fatigue (LIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211273
Recruitment Status : Withdrawn (no funding)
First Posted : July 7, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
University Hospital Heidelberg
Information provided by (Responsible Party):
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.

Condition or disease
Cancer-related 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Group/Cohort
Patient cohort
Newly diagnosed breast, ovarian or colon cancer patients recruited 6 months post-diagnosis and followed up to 5 years post-diagnosis. No intervention.



Primary Outcome Measures :
  1. Fatigue severity [ Time Frame: 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)

  2. Impact of fatigue [ Time Frame: from diagnosis to 1 year post-diagnosis ]
    assessed by the Brief Fatigue Inventory (BFI)

  3. State of fatigue management [ Time Frame: 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 :
  1. Quality of life functions and symptoms [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed by EORTC QLQ-C30

  2. Sleep problems [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed by Pittsburgh Sleep Quality Index (PSQI)

  3. Depression [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed by Patient Health Questionnaire (PHQ-9)

  4. Body mass index [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    calculated from weight and height

  5. Total physical activity [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed by a questionnaire regarding walking, cycling, and exercise behavior

  6. Diurnal cortisol rhythm [ Time Frame: 1 year post-diagnosis ]
    assessed in saliva

  7. Return to work [ Time Frame: 6, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed by a questions regarding occupational issues

  8. Hot flashes [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed only for women

  9. Anxiety [ Time Frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis ]
    assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)


Biospecimen Retention:   Samples Without DNA
Diurnal saliva samples (5 samples distributed over a day)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients newly diagnosed with breast, ovarian or colon cancer
Criteria

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

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Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT03211273    
Other Study ID Numbers: LIFT
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms