Clinical trial NCT05868187: CanRestoreFunction Cancer-related Fatigue ( CRF )
Official title: CanRestoreFunction: Cancer-Related Fatigue Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Keywords: cancer-related fatigue
breast cancer
exercise
problem-solving
online interactive education
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Dayton
First posted: 2023-05-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Brief Fatigue Inventory
timeFrame: Baseline
measure: Brief Fatigue Inventory
timeFrame: 4-week
measure: Brief Fatigue Inventory
timeFrame: 8-week
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: Baseline
measure: Canadian Occupational Performance Measure
timeFrame: 4-week
measure: Canadian Occupational Performance Measure
timeFrame: 8-week
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Baseline
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: 4-weeks
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: 8-weeks
measure: PROMIS Cognitive Function Ability 8a
timeFrame: Baseline
measure: PROMIS Cognitive Function Ability 8a
timeFrame: 4-weeks
measure: PROMIS Cognitive Function Ability 8a
timeFrame: 8-weeks
measure: Promis Applied Cognitive Abilities 8a
timeFrame: Baseline
measure: Promis Applied Cognitive Abilities 8a
timeFrame: 4-weeks
measure: Promis Applied Cognitive Abilities 8a
timeFrame: 8-weeks
measure: 6-minute walk test
timeFrame: Baseline
measure: 6-minute walk test
timeFrame: 4-weeks
measure: 6-minute walk test
timeFrame: 8-weeks
measure: 30 second sit to stand
timeFrame: Baseline
measure: 30 second sit to stand
timeFrame: 4-weeks
measure: 30 second sit to stand
timeFrame: 8-weeks
measure: Average number of steps
timeFrame: Week 1
measure: Average number of steps
timeFrame: Week 2
measure: Average number of steps
timeFrame: Week 3
measure: Average number of steps
timeFrame: Week 4
measure: Average number of steps
timeFrame: Week 5
measure: Average number of steps
timeFrame: Week 6
measure: Average number of steps
timeFrame: Week 7
measure: Average number of steps
timeFrame: Week 8
measure: Average heart rate
timeFrame: Week 1
measure: Average heart rate
timeFrame: Week 2
measure: Average heart rate
timeFrame: Week 3
measure: Average heart rate
timeFrame: Week 4
measure: Average heart rate
timeFrame: Week 5
measure: Average heart rate
timeFrame: Week 6
measure: Average heart rate
timeFrame: Week 7
measure: Average heart rate
timeFrame: Week 8
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Anne Fleischer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: