An interventional study of Exercise, Problem-Solving Session and Education in Breast Neoplasm, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 47 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules
Behavioral: Exercise, Problem-Solving Session and Education
Participants will complete their daily routines as they typically do.
Complete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules
Brief Fatigue Inventory
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time frame: Baseline
Brief Fatigue Inventory
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time frame: 4-week
Brief Fatigue Inventory
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time frame: 8-week
Canadian Occupational Performance Measure
The OT administers the COPM, which is a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates "no importance" and 10 indicates "very important." Then the participant separately rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that "they are not able to perform" or "they are not satisfied" and 10 indicates that "they are able to perform the activity well" or "they are very satisfied."
Time frame: Baseline
Canadian Occupational Performance Measure
The OT administers the COPM, which is a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates "no importance" and 10 indicates "very important." Then the participant separately rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that "they are not able to perform" or "they are not satisfied" and 10 indicates that "they are able to perform the activity well" or "they are very satisfied."
Time frame: 4-week
Canadian Occupational Performance Measure
The OT administers the COPM, which is a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates "no importance" and 10 indicates "very important." Then the participant separately rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that "they are not able to perform" or "they are not satisfied" and 10 indicates that "they are able to perform the activity well" or "they are very satisfied."
Time frame: 8-week
Functional Assessment of Chronic Illness Therapy-Fatigue
This 40-item 5-point Likert scale (0=Not at all 1=A little bit 2=Somewhat 3= Quite a bit 4=Very much) evaluates quality of life in individuals with fatigue as measured in 5 domains: physical, social/family, emotional, functional well-being, and fatigue. Higher scores reflect greater quality of life
Time frame: Baseline
Functional Assessment of Chronic Illness Therapy-Fatigue
This 40-item 5-point Likert scale (0=Not at all 1=A little bit 2=Somewhat 3= Quite a bit 4=Very much) evaluates quality of life in individuals with fatigue as measured in 5 domains: physical, social/family, emotional, functional well-being, and fatigue. Higher scores reflect greater quality of life
Time frame: 4-weeks
Functional Assessment of Chronic Illness Therapy-Fatigue
This 40-item 5-point Likert scale (0=Not at all 1=A little bit 2=Somewhat 3= Quite a bit 4=Very much) evaluates quality of life in individuals with fatigue as measured in 5 domains: physical, social/family, emotional, functional well-being, and fatigue. Higher scores reflect greater quality of life
Time frame: 8-weeks
PROMIS Cognitive Function Ability 8a
This 8-item 5-point Likert scale \[Never, Rarely (Once) Sometimes (Two or three times) Often (About once a day) Very often (Several times a day)\] evaluates patient-perceived cognitive abilities, its interference with daily functioning, whether other people observe cognitive impairments, and its impact on quality of life
Time frame: Baseline
PROMIS Cognitive Function Ability 8a
This 8-item 5-point Likert scale \[Never, Rarely (Once) Sometimes (Two or three times) Often (About once a day) Very often (Several times a day)\] evaluates patient-perceived cognitive abilities, its interference with daily functioning, whether other people observe cognitive impairments, and its impact on quality of life
Time frame: 4-weeks
PROMIS Cognitive Function Ability 8a
This 8-item 5-point Likert scale \[Never, Rarely (Once) Sometimes (Two or three times) Often (About once a day) Very often (Several times a day)\] evaluates patient-perceived cognitive abilities, its interference with daily functioning, whether other people observe cognitive impairments, and its impact on quality of life
Time frame: 8-weeks
Promis Applied Cognitive Abilities 8a
This 8-item 5-point Likert scale \[Not at all A little bit, Somewhat, Quite a bit, Very much\] evaluates the patient-perceived cognitive deficits
Time frame: Baseline
Promis Applied Cognitive Abilities 8a
This 8-item 5-point Likert scale \[Not at all A little bit, Somewhat, Quite a bit, Very much\] evaluates the patient-perceived cognitive deficits
Time frame: 4-weeks
Promis Applied Cognitive Abilities 8a
This 8-item 5-point Likert scale \[Not at all A little bit, Somewhat, Quite a bit, Very much\] evaluates the patient-perceived cognitive deficits
Time frame: 8-weeks
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Time frame: Baseline
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Time frame: 4-weeks
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Time frame: 8-weeks
30 second sit to stand
Participants are seated in a standard height fixed chair without armrests, which is placed against a wall. They will move from sitting to standing and back to sitting position, with arms crossed against chest. The number of complete stands and sits
Time frame: Baseline
30 second sit to stand
Participants are seated in a standard height fixed chair without armrests, which is placed against a wall. They will move from sitting to standing and back to sitting position, with arms crossed against chest. The number of complete stands and sits
Time frame: 4-weeks
30 second sit to stand
Participants are seated in a standard height fixed chair without armrests, which is placed against a wall. They will move from sitting to standing and back to sitting position, with arms crossed against chest. The number of complete stands and sits
Time frame: 8-weeks
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 1
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 2
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 3
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 4
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 5
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 6
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 7
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Time frame: Week 8
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 1
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 2
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 3
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 4
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 5
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 6
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 7
Average heart rate
Fitbit will track daily heart rate of each participant
Time frame: Week 8
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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