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Online Program for Fatigue in Breast Cancer (CRF Trial)
N/A
Recruiting
Led By Anne Fleischer, Ph.D
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a significant level of fatigue defined as >3 on 0-10 scale using the Oneitem Fatigue Scale
Received chemotherapy and/or radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
CRF Trial Summary
This trial will evaluate if an 8-week online program can reduce cancer-related fatigue and improve quality of life, ability, satisfaction, mobility, and cognition for breast cancer patients.
Who is the study for?
This trial is for breast cancer patients who've been diagnosed within the last 5 years and are experiencing significant fatigue. Participants must have completed chemotherapy or radiation, be able to use a computer or mobile device, and have their doctor's approval to exercise. Those with stage 4 cancer, chronic pre-cancer fatigue conditions like fibromyalgia, or language barriers (non-English speakers) cannot join.Check my eligibility
What is being tested?
The study tests an 8-week online program designed to manage cancer-related fatigue in breast cancer survivors. It includes personalized exercises, problem-solving sessions, goal setting, action planning, and educational content. The effectiveness will be compared against a wait-list control group.See study design
What are the potential side effects?
Since this intervention involves exercise and education without medical drugs or invasive procedures, side effects may include typical exercise-related discomforts such as muscle soreness or strain but should generally be minimal.
CRF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel very tired, scoring over 3 on a fatigue scale.
Select...
I have undergone chemotherapy or radiation therapy.
CRF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8-week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Fatigue Inventory
Secondary outcome measures
30 second sit to stand
6-minute walk test
Average heart rate
+5 moreCRF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise, Problem-Solving and EducationExperimental Treatment1 Intervention
Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules
Group II: Usual CareActive Control1 Intervention
Participants will complete their daily routines as they typically do.
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Who is running the clinical trial?
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,362 Total Patients Enrolled
2 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
University of DaytonOTHER
3 Previous Clinical Trials
140 Total Patients Enrolled
Anne Fleischer, Ph.DPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been experiencing long-term tiredness before being diagnosed with cancer, such as fibromyalgia.My cancer has spread to other parts of my body (Stage 4).I do not speak English.I was diagnosed with cancer within the last 5 years.I often feel very tired, scoring over 3 on a fatigue scale.I have undergone chemotherapy or radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise, Problem-Solving and Education
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research protocol open to individuals over 20 years of age?
"The minimum age restriction to join this trial is 18 years old and the maximum age allowed for consideration is 70."
Answered by AI
Who would be the ideal candidates for this research study?
"This medical study is searching for roughly 32 participants with a diagnosis of breast cancer, aged between 18 and 70."
Answered by AI
What is the aggregate number of participants in this experiment?
"Affirmative. Per the data on clinicaltrials.gov, this medical trial is still open and actively seeking participants; it was first posted on March 1st 2023 and updated most recently on May 11th 2023. The study requires 32 patients from a single site."
Answered by AI
Are enrollments being accepted for this clinical research at present?
"Affirmative. Per clinicaltrials.gov, this research is accepting participants at the present moment and was initially posted on March 1st 2023 with its most recent update occurring on May 11th2023. The study will enroll 32 individuals from one location."
Answered by AI
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