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Completed

NCT Number: NCT05868187

CanRestoreFunction Cancer-related Fatigue ( CRF )

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

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Key information

Conditions

Breast Neoplasm Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise, Problem-Solving Session and Education

Behavioral

Complete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules

Primary outcomes

  1. Brief Fatigue Inventory

    Time frame: Baseline

    This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

  2. Brief Fatigue Inventory

    Time frame: 4-week

    This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

  3. Brief Fatigue Inventory

    Time frame: 8-week

    This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

Secondary outcomes

  1. Canadian Occupational Performance Measure

    Time frame: Baseline

    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."

  2. Canadian Occupational Performance Measure

    Time frame: 4-week

    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."

  3. Canadian Occupational Performance Measure

    Time frame: 8-week

    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."

  4. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: Baseline

    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

  5. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: 4-weeks

    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

  6. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: 8-weeks

    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

  7. PROMIS Cognitive Function Ability 8a

    Time frame: Baseline

    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

  8. PROMIS Cognitive Function Ability 8a

    Time frame: 4-weeks

    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

  9. PROMIS Cognitive Function Ability 8a

    Time frame: 8-weeks

    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

  10. Promis Applied Cognitive Abilities 8a

    Time frame: Baseline

    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

  11. Promis Applied Cognitive Abilities 8a

    Time frame: 4-weeks

    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

  12. Promis Applied Cognitive Abilities 8a

    Time frame: 8-weeks

    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

  13. 6-minute walk test

    Time frame: Baseline

    Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks

  14. 6-minute walk test

    Time frame: 4-weeks

    Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks

  15. 6-minute walk test

    Time frame: 8-weeks

    Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks

  16. 30 second sit to stand

    Time frame: Baseline

    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

  17. 30 second sit to stand

    Time frame: 4-weeks

    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

  18. 30 second sit to stand

    Time frame: 8-weeks

    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

  19. Average number of steps

    Time frame: Week 1

    Fitbit will track the number of steps that the participants takes each day

  20. Average number of steps

    Time frame: Week 2

    Fitbit will track the number of steps that the participants takes each day

  21. Average number of steps

    Time frame: Week 3

    Fitbit will track the number of steps that the participants takes each day

  22. Average number of steps

    Time frame: Week 4

    Fitbit will track the number of steps that the participants takes each day

  23. Average number of steps

    Time frame: Week 5

    Fitbit will track the number of steps that the participants takes each day

  24. Average number of steps

    Time frame: Week 6

    Fitbit will track the number of steps that the participants takes each day

  25. Average number of steps

    Time frame: Week 7

    Fitbit will track the number of steps that the participants takes each day

  26. Average number of steps

    Time frame: Week 8

    Fitbit will track the number of steps that the participants takes each day

  27. Average heart rate

    Time frame: Week 1

    Fitbit will track daily heart rate of each participant

  28. Average heart rate

    Time frame: Week 2

    Fitbit will track daily heart rate of each participant

  29. Average heart rate

    Time frame: Week 3

    Fitbit will track daily heart rate of each participant

  30. Average heart rate

    Time frame: Week 4

    Fitbit will track daily heart rate of each participant

  31. Average heart rate

    Time frame: Week 5

    Fitbit will track daily heart rate of each participant

  32. Average heart rate

    Time frame: Week 6

    Fitbit will track daily heart rate of each participant

  33. Average heart rate

    Time frame: Week 7

    Fitbit will track daily heart rate of each participant

  34. Average heart rate

    Time frame: Week 8

    Fitbit will track daily heart rate of each participant

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • University of Dayton

Registry information

Official study title

CanRestoreFunction: Cancer-Related Fatigue Management

Acronym: CRF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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