NeoplasmsNCT05017597
Online Cancer-Related Fatigue Management
A study testing Rehabilitation in people with Neoplasms and Fatigue, run by Eastern Kentucky University at 1 site in United States.
Trial summary
Many individuals who have had cancer experience functional limitations during and after their treatments. The most common side effect from cancer treatment that restricts cancer survivors' completion of daily activities is cancer-related fatigue. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completed treatment for a cancer diagnosis within 5 years of enrollment
- Access to mobile device or computer
- Basic computer or mobile device skills
- Experience a significant level of fatigue defined as >= 4 on 0-10 scale using the One-item Fatigue Scale.
Who cannot join
- Currently undergoing chemotherapy or radiation treatment
- Unwilling to participate in an exercise program
- Have metastatic cancer (Stage 4)
- Do not have physician consent to participate in the exercise program
- Unable to follow verbal or written assessment instructions
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
About this study
Many individuals who have had cancer experience functional limitations during and after their treatments. The most common side effect from cancer treatment that restricts cancer survivors' completion of daily activities is cancer-related fatigue. Here, we propose to investigate whether an interprofessional approach that targets physiologic, psychologic, and ecological factors will minimize cancer-related fatigue and enhance daily life participation for volunteer cancer survivors living in the community. The interprofessional team will include occupational therapy professor and students from Eastern Kentucky University (EKU), physical therapy and dietitian professors and their students from the University of Dayton, and instructional design instructor from EKU. The approach will include (1) individualized exercise programs-via physical therapy; (2) problem-solving strategies including modifying the environment or activity -via occupational therapy; (3) goal development via physical and occupational therapy; and (4) cancer-related fatigue education via instructional design. We hypothesize that this approach will result in participants experiencing less fatigue, increasing their mobility, improving their quality of life, and being more satisfied with how they perform daily activities.
Read the detailed description
Setting: Virtual environment
- Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton.
- Educational and Exercise Videos will be accessed within an individual webpage for each participant within the study's website.
Research Design Pre-test/Post-test quasi-experimental design without a control group. This research design will allow us to assess if there is a change in the level of fatigue, mobility, quality of life, and/or perceived performance and satisfaction of important activities Screening Individuals who are interested in participating will contact the Occupational Therapy professor--principal investigator (PI) or Physical Therapy professor-collaborator (CL). PI or CL will contact the potential participant either by telephone or email. Within this initial communication, the potential participant will be provided with the following information: time commitment, type of evaluations, and intervention. If the participant continues to be interested, an electronic inclusion criteria screen will be sent. If all inclusion criteria are met, PI or CL will ask the participant for their physician contact information so a medical release form can be sent to them.
Physician medical release A release form will be faxed, sent electronically, or mailed to participant's oncology or primary care provider. Once this signed release is received, we will send an electronic version of the informed consent to the potential participant and schedule a time to review it and a tentative time for the initial evaluation.
Initial, Weekly, 4-week, and 8-week Standard of Care Cancer Survivor Evaluations Initial Evaluations After the participant agrees to take part in the study and signs the informed consent, the initial evaluation including questionnaires and physical therapy and occupational therapy assessments within one to two visits will be administered by physical therapy and occupational therapy students (PTSI and OTSI). Assessments will be recorded and reviewed by the supervising therapy professor to ensure assessments are performed using standardized methods. After the assessment eight weekly meetings will be schedule.
- Estimated length of weekly meeting is 20-30 minutes.
- Each exercise session is 30-45 minutes in length depending on which level of exercise the participant is completing. The participant will complete 3 sessions each week.
- Each participant will be provided their own webpage, which can only be accessed by them and the researchers. Within the webpage, the researchers will store the prescribed exercise program, including handouts, video and exercise log, and the problem-solving session goals and action plans. Links to the Cancer-Related Fatigue (CRF) educational modules, as they are assigned to the participant will be posted as well.
- Being tested
- Rehabilitation
- Keywords
- Function, Fatigue, Occupation, Exercise
- Medical subject headings
- Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Exercises completed, and rate of perceived exertion (RPE) will be reviewed during \& after each exercise session. Exercises will be modified by either increasing or decreasing the intensity. Decisions will be made based RPE, physical symptoms \& any identified barriers or supports. Weeks 1, 3, 5, \& 7, Cancer-related fatigue (CRF) education will be assigned. During weeks 2, 4, 6, \& 8, CRF education will be reviewed and a plan for how to apply the information will be developed. Participant will be guided through 6 steps of problem solving to address one occupational performance problem identified by participant within Canadian Occupational Performance Measure. Goal \& action plan for the week will be shared with the participant electronically. At the beginning of each session, participant will describe progress on previous week action plan. Based on participant's response, either a new goal will be developed or the current one modified..
| Study group | Role | What they receive |
|---|---|---|
| Fatigue management | Experimental | Prescribed exercises by Physical Therapy Problem-Solving Sessions to resume activities that ther person needs to do, wants to do or is expected to do.
Four online educational modules: What is Cancer-Related Fatigue? Nutrition, Sleep Hygiene and Exercise Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatiue Level: Brief Fatigue Inventory
This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale
Measured: Change from Baseline measure at 4 weeks
Change in Fatiue Level: Brief Fatigue Inventory
This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale
Measured: Change from 4 week measure at 8 weeks
Perceived Functional Change: Canadian Occupational Performance Measure
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 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." This is repeated for how satisficed with how they currently perform each important activity.
Measured: Change from Baseline measure at 4 weeks
Perceived Functional Change: Canadian Occupational Performance Measure
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 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." This is repeated for how satisficed with how they currently perform each important activity.
Measured: Change from 4 week measure at 8 weeks
Secondary outcomes (8)
One Item Fatigue Scale
Participants answer the following question: "How would you rate your fatigue on a scale of 0 to10 with 0 being 'no fatigue' and 10 being the 'worst possible fatigue'
Measured: Change from baseline measure at 8 weeks
FACIT-Fatigue
This 40-item 5-point Likert scale 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
Measured: Change from Baseline measure at 8 weeks
6-minute walk test
Participants will complete a 6-minute walk at their chosen pace, using assistive devices if needed and with permitted standing rest breaks. Participants will be required to measure the length of a hallway, sidewalk, or driveway where they will be walking. They will then walk for 6 minutes. Participants will report the distance walked as well as the number of rest breaks taken during the 6 minutes.
Measured: Change from baseline measure at 4 weeks
6-minute walk test
Participants will complete a 6-minute walk at their chosen pace, using assistive devices if needed and with permitted standing rest breaks. Participants will be required to measure the length of a hallway, sidewalk, or driveway where they will be walking. They will then walk for 6 minutes. Participants will report the distance walked as well as the number of rest breaks taken during the 6 minutes.
Measured: Change from 4 week measure at 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 (1 repetition) will be counted by the investigator and the participant within 30 seconds
Measured: Change from baseline measure at 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 (1 repetition) will be counted by the investigator and the participant within 30 seconds
Measured: Change from 4 week measure at 8 weeks
Borg Perceived Exertion 6-20 scale
This scale allows participants to rate their perceived exertion during physical activity. Patients will be instructed to rate their level of exertion during their home exercise program and at the conclusion of each session. This will be recorded on their weekly exercise log.
Measured: Change from baseline measure to 4 weeks
Borg Perceived Exertion 6-20 scale
This scale allows participants to rate their perceived exertion during physical activity. Patients will be instructed to rate their level of exertion during their home exercise program and at the conclusion of each session. This will be recorded on their weekly exercise log.
Measured: Change from 4 week measure to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Mar 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Principal investigator left the unversity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Kentucky University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dayton
- Responsible party
- Principal investigator, ANNE FLEISCHER, Eastern Kentucky University
- Investigators
- Anne Fleischer, Ph.D, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017597
- Sponsor's protocol ID
- EasternKU
- Status last verified
- Sep 2023
- First submitted
- 10 Jun 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only researchers involved in this study, who have been approved by the Institutional Review Board, will have access to the data.
Publications
Bronfenbrenner U. Toward an experimental ecology of human development. American Psychologist. 1977. 32: 513-531
Champion VL, Wagner LI, Monahan PO, Daggy J, Smith L, Cohee A, Ziner KW, Haase JE, Miller KD, Pradhan K, Unverzagt FW, Cella D, Ansari B, Sledge GW Jr. Comparison of younger and older breast cancer survivors and age-matched controls on specific and overall quality of life domains. Cancer. 2014 Aug 1;120(15):2237-46. doi: 10.1002/cncr.28737. Epub 2014 May 28.
PubMed 24891116Du S, Hu L, Dong J, Xu G, Jin S, Zhang H, Yin H. Patient education programs for cancer-related fatigue: A systematic review. Patient Educ Couns. 2015 Nov;98(11):1308-19. doi: 10.1016/j.pec.2015.05.003. Epub 2015 May 23.
PubMed 26072422Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822-9. doi: 10.1097/mss.0b013e31803349c6.
PubMed 17468581Hegel MT, Lyons KD, Hull JG, Kaufman P, Urquhart L, Li Z, Ahles TA. Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy. Psychooncology. 2011 Oct;20(10):1092-101. doi: 10.1002/pon.1830. Epub 2010 Sep 5.
PubMed 20821373Hong Y, Pena-Purcell NC, Ory MG. Outcomes of online support and resources for cancer survivors: a systematic literature review. Patient Educ Couns. 2012 Mar;86(3):288-96. doi: 10.1016/j.pec.2011.06.014. Epub 2011 Jul 27.
PubMed 21798685Hoybye MT, Dalton SO, Deltour I, Bidstrup PE, Frederiksen K, Johansen C. Effect of Internet peer-support groups on psychosocial adjustment to cancer: a randomised study. Br J Cancer. 2010 Apr 27;102(9):1348-54. doi: 10.1038/sj.bjc.6605646.
PubMed 20424614Lindahl-Jacobsen L, Hansen DG, Waehrens EE, la Cour K, Sondergaard J. Performance of activities of daily living among hospitalized cancer patients. Scand J Occup Ther. 2015 Mar;22(2):137-46. doi: 10.3109/11038128.2014.985253. Epub 2015 Jan 12.
PubMed 25580840Lyons KD, Newman RM, Kaufman PA, Bruce ML, Stearns DM, Lansigan F, Chamberlin M, Bartels SJ, Whipple J, Hegel MT. Goal Attainment and Goal Adjustment of Older Adults During Person-Directed Cancer Rehabilitation. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205110p1-7202205110p8. doi: 10.5014/ajot.2018.023648.
PubMed 29426388Ma Y, He B, Jiang M, Yang Y, Wang C, Huang C, Han L. Prevalence and risk factors of cancer-related fatigue: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Nov;111:103707. doi: 10.1016/j.ijnurstu.2020.103707. Epub 2020 Jul 11.
PubMed 32920423Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.
PubMed 22895961Silver JK, Baima J, Newman R, Galantino ML, Shockney LD. Cancer rehabilitation may improve function in survivors and decrease the economic burden of cancer to individuals and society. Work. 2013;46(4):455-72. doi: 10.3233/WOR-131755.
PubMed 24125901Owen JE, Klapow JC, Roth DL, Shuster JL Jr, Bellis J, Meredith R, Tucker DC. Randomized pilot of a self-guided internet coping group for women with early-stage breast cancer. Ann Behav Med. 2005 Aug;30(1):54-64. doi: 10.1207/s15324796abm3001_7.
PubMed 16097906Salzer MS, Palmer SC, Kaplan K, Brusilovskiy E, Ten Have T, Hampshire M, Metz J, Coyne JC. A randomized, controlled study of Internet peer-to-peer interactions among women newly diagnosed with breast cancer. Psychooncology. 2010 Apr;19(4):441-6. doi: 10.1002/pon.1586.
PubMed 19484712Smith TM, Broomhall CN, Crecelius AR. Physical and Psychological Effects of a 12-Session Cancer Rehabilitation Exercise Program. Clin J Oncol Nurs. 2016 Dec 1;20(6):653-659. doi: 10.1188/16.CJON.653-659.
PubMed 27857248
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cancer-Related Fatigue Management
- ClinicalTrials.gov ID
- NCT05017597
- Acronym / sponsor ID
- EasternKU
- Keywords
- Function, Fatigue, Occupation, Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator left the unversity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Kentucky UniversityUniversity, hospital or other
- Collaborators
- University of Dayton
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many individuals who have had cancer experience functional limitations during and after their treatments. The most common side effect from cancer treatment that restricts cancer survivors' completion of daily activities is cancer-related fatigue. Here, we propose to investigate whether an interprofessional approach that targets physiologic, psychologic, and ecological factors will minimize cancer-related fatigue and enhance daily life participation for volunteer cancer survivors living in the community. The interprofessional team will include occupational therapy professor and students from Eastern Kentucky University (EKU), physical therapy and dietitian professors and their students from the University of Dayton, and instructional design instructor from EKU. The approach will include (1) individualized exercise programs-via physical therapy; (2) problem-solving strategies including modifying the environment or activity -via occupational therapy; (3) goal development via physical and occupational therapy; and (4) cancer-related fatigue education via instructional design. We hypothesize that this approach will result in participants experiencing less fatigue, increasing their mobility, improving their quality of life, and being more satisfied with how they perform daily activities.
Detailed description
Setting: Virtual environment
- Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton.
- Educational and Exercise Videos will be accessed within an individual webpage for each participant within the study's website.
Research Design Pre-test/Post-test quasi-experimental design without a control group. This research design will allow us to assess if there is a change in the level of fatigue, mobility, quality of life, and/or perceived performance and satisfaction of important activities Screening Individuals who are interested in participating will contact the Occupational Therapy professor--principal investigator (PI) or Physical Therapy professor-collaborator (CL). PI or CL will contact the potential participant either by telephone or email. Within this initial communication, the potential participant will be provided with the following information: time commitment, type of evaluations, and intervention. If the participant continues to be interested, an electronic inclusion criteria screen will be sent. If all inclusion criteria are met, PI or CL will ask the participant for their physician contact information so a medical release form can be sent to them.
Physician medical release A release form will be faxed, sent electronically, or mailed to participant's oncology or primary care provider. Once this signed release is received, we will send an electronic version of the informed consent to the potential participant and schedule a time to review it and a tentative time for the initial evaluation.
Initial, Weekly, 4-week, and 8-week Standard of Care Cancer Survivor Evaluations Initial Evaluations After the participant agrees to take part in the study and signs the informed consent, the initial evaluation including questionnaires and physical therapy and occupational therapy assessments within one to two visits will be administered by physical therapy and occupational therapy students (PTSI and OTSI). Assessments will be recorded and reviewed by the supervising therapy professor to ensure assessments are performed using standardized methods. After the assessment eight weekly meetings will be schedule.
- Estimated length of weekly meeting is 20-30 minutes.
- Each exercise session is 30-45 minutes in length depending on which level of exercise the participant is completing. The participant will complete 3 sessions each week.
- Each participant will be provided their own webpage, which can only be accessed by them and the researchers. Within the webpage, the researchers will store the prescribed exercise program, including handouts, video and exercise log, and the problem-solving session goals and action plans. Links to the Cancer-Related Fatigue (CRF) educational modules, as they are assigned to the participant will be posted as well.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue management | Experimental | Other: RehabilitationPrescribed exercises by Physical Therapy Problem-Solving Sessions to resume activities that ther person needs to do, wants to do or is expected to do. Four online educational modules: What is Cancer-Related Fatigue? Nutrition, Sleep Hygiene and Exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completed treatment for a cancer diagnosis within 5 years of enrollment
- Access to mobile device or computer
- Basic computer or mobile device skills
- Experience a significant level of fatigue defined as >= 4 on 0-10 scale using the One-item Fatigue Scale.
Key exclusion criteria (6 listed)
- Currently undergoing chemotherapy or radiation treatment
- Unwilling to participate in an exercise program
- Have metastatic cancer (Stage 4)
- Do not have physician consent to participate in the exercise program
- Unable to follow verbal or written assessment instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationExercises completed, and rate of perceived exertion (RPE) will be reviewed during \& after each exercise session. Exercises will be modified by either increasing or decreasing the intensity. Decisions will be made based RPE, physical symptoms \& any identified barriers or supports. Weeks 1, 3, 5, \& 7, Cancer-related fatigue (CRF) education will be assigned. During weeks 2, 4, 6, \& 8, CRF education will be reviewed and a plan for how to apply the information will be developed. Participant will be guided through 6 steps of problem solving to address one occupational performance problem identified by participant within Canadian Occupational Performance Measure. Goal \& action plan for the week will be shared with the participant electronically. At the beginning of each session, participant will describe progress on previous week action plan. Based on participant's response, either a new goal will be developed or the current one modified.. | Other | Fatigue management |
Primary outcome
Change in Fatiue Level: Brief Fatigue Inventory
Time frame: Change from Baseline measure at 4 weeks
This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale
Change in Fatiue Level: Brief Fatigue Inventory
Time frame: Change from 4 week measure at 8 weeks
This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale
Perceived Functional Change: Canadian Occupational Performance Measure
Time frame: Change from Baseline measure at 4 weeks
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 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." This is repeated for how satisficed with how they currently perform each important activity.
Perceived Functional Change: Canadian Occupational Performance Measure
Time frame: Change from 4 week measure at 8 weeks
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 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." This is repeated for how satisficed with how they currently perform each important activity.
8 secondary outcomes
One Item Fatigue Scale
Time frame: Change from baseline measure at 8 weeks
FACIT-Fatigue
Time frame: Change from Baseline measure at 8 weeks
6-minute walk test
Time frame: Change from baseline measure at 4 weeks
6-minute walk test
Time frame: Change from 4 week measure at 8 weeks
30-second Sit to Stand
Time frame: Change from baseline measure at 4 weeks
30-second Sit to Stand
Time frame: Change from 4 week measure at 8 weeks
Borg Perceived Exertion 6-20 scale
Time frame: Change from baseline measure to 4 weeks
Borg Perceived Exertion 6-20 scale
Time frame: Change from 4 week measure to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- BackgroundBronfenbrenner U. Toward an experimental ecology of human development. American Psychologist. 1977. 32: 513-531
- Background: PubMed 24891116Champion VL, Wagner LI, Monahan PO, Daggy J, Smith L, Cohee A, Ziner KW, Haase JE, Miller KD, Pradhan K, Unverzagt FW, Cella D, Ansari B, Sledge GW Jr. Comparison of younger and older breast cancer survivors and age-matched controls on specific and overall quality of life domains. Cancer. 2014 Aug 1;120(15):2237-46. doi: 10.1002/cncr.28737. Epub 2014 May 28.
- Background: PubMed 26072422Du S, Hu L, Dong J, Xu G, Jin S, Zhang H, Yin H. Patient education programs for cancer-related fatigue: A systematic review. Patient Educ Couns. 2015 Nov;98(11):1308-19. doi: 10.1016/j.pec.2015.05.003. Epub 2015 May 23.
- Background: PubMed 17468581Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822-9. doi: 10.1097/mss.0b013e31803349c6.
- Background: PubMed 20821373Hegel MT, Lyons KD, Hull JG, Kaufman P, Urquhart L, Li Z, Ahles TA. Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy. Psychooncology. 2011 Oct;20(10):1092-101. doi: 10.1002/pon.1830. Epub 2010 Sep 5.
- Background: PubMed 21798685Hong Y, Pena-Purcell NC, Ory MG. Outcomes of online support and resources for cancer survivors: a systematic literature review. Patient Educ Couns. 2012 Mar;86(3):288-96. doi: 10.1016/j.pec.2011.06.014. Epub 2011 Jul 27.
- Background: PubMed 20424614Hoybye MT, Dalton SO, Deltour I, Bidstrup PE, Frederiksen K, Johansen C. Effect of Internet peer-support groups on psychosocial adjustment to cancer: a randomised study. Br J Cancer. 2010 Apr 27;102(9):1348-54. doi: 10.1038/sj.bjc.6605646.
- Background: PubMed 25580840Lindahl-Jacobsen L, Hansen DG, Waehrens EE, la Cour K, Sondergaard J. Performance of activities of daily living among hospitalized cancer patients. Scand J Occup Ther. 2015 Mar;22(2):137-46. doi: 10.3109/11038128.2014.985253. Epub 2015 Jan 12.
- Background: PubMed 29426388Lyons KD, Newman RM, Kaufman PA, Bruce ML, Stearns DM, Lansigan F, Chamberlin M, Bartels SJ, Whipple J, Hegel MT. Goal Attainment and Goal Adjustment of Older Adults During Person-Directed Cancer Rehabilitation. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205110p1-7202205110p8. doi: 10.5014/ajot.2018.023648.
- Background: PubMed 32920423Ma Y, He B, Jiang M, Yang Y, Wang C, Huang C, Han L. Prevalence and risk factors of cancer-related fatigue: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Nov;111:103707. doi: 10.1016/j.ijnurstu.2020.103707. Epub 2020 Jul 11.
- Background: PubMed 22895961Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.
- Background: PubMed 24125901Silver JK, Baima J, Newman R, Galantino ML, Shockney LD. Cancer rehabilitation may improve function in survivors and decrease the economic burden of cancer to individuals and society. Work. 2013;46(4):455-72. doi: 10.3233/WOR-131755.
- Individual participant dataSharing planned: No. Only researchers involved in this study, who have been approved by the Institutional Review Board, will have access to the data.
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Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Fleischer, Ph.D principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Neoplasms and Fatigue, run by Eastern Kentucky University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatiue Level: Brief Fatigue Inventory (time frame: Change from Baseline measure at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017597, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.