NCT03211273

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

July 3, 2017

Last Update Submit

August 22, 2019

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Quality of life functions and symptoms

    6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis

  • Sleep problems

    6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis

  • Depression

    6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis

  • Body mass index

    6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis

  • Total physical activity

    6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis

  • +4 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients newly diagnosed with breast, ovarian or colon cancer

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Diurnal saliva samples (5 samples distributed over a day)

0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 7, 2017

Study Start

March 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2025

Last Updated

August 28, 2019

Record last verified: 2019-08