Longitudinal Investigation of Cancer-related Fatigue (LIFT)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: 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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients newly diagnosed with breast, ovarian or colon cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: German Cancer Research Center
• Collaborators: University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: LIFT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No