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Trial Title:
CanRestoreFunction Cancer-related Fatigue ( CRF )
NCT ID:
NCT05868187
Condition:
Breast Neoplasm
Conditions: Official terms:
Breast Neoplasms
Fatigue
Conditions: Keywords:
cancer-related fatigue
breast cancer
exercise
problem-solving
online interactive education
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise, Problem-Solving Session and Education
Description:
Complete assigned exercises three times a week Complete Action plan co-developed Complete
part or all of one of the four interactive educational modules
Arm group label:
Exercise, Problem-Solving and Education
Summary:
The goal of this randomized control trial is to determine if participating in an 8-week
online cancer-related fatigue management intervention consisting of individualized
exercise program, one-on-one goal setting and action plan development and interactive
educational module will significantly reduce the perception of cancer-related fatigue,
improve the quality of life, improve perceived cognition, and perceived function of
breast cancer compared to a wait-list control group. The aim the project is to determine
if an online cancerrelated fatigue management program is associated with 1. A decrease in
cancer-related fatigue. 2. An improved perception of their ability and satisfaction in
completing important activities 3. Greater quality of life. 4. Improved mobility 5.
Improved perceived cognition
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- been diagnosed with any type of cancer within 5 years of enrollment,
- received chemotherapy and/or radiation therapy
- have access to mobile device or computer
- have basic computer or mobile device skills,
- have a significant level of fatigue defined as >3 on 0-10 scale using the Oneitem
Fatigue Scale
Exclusion Criteria:
- have metastatic cancer (Stage 4),
- do not have a signed medical release by their physician or physician extender
indicating that the participant can safely participate in the exercise program,
- chronic fatigue prior to cancer diagnosis, such as fibromyalgia
- are unable to follow verbal or written assessment instructions, are non-English
speaking
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45221
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anne Fleischer, Ph.D
Phone:
513-558-3732
Email:
CaRehabResearch@gmail.com
Start date:
March 1, 2023
Completion date:
April 30, 2024
Lead sponsor:
Agency:
University of Cincinnati
Agency class:
Other
Collaborator:
Agency:
University of Dayton
Agency class:
Other
Source:
University of Cincinnati
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05868187
