Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-03-01
2023-09-30
Brief Summary
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Detailed Description
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1. Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton.
2. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Fatigue management
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
Rehabilitation
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..
Interventions
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Rehabilitation
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..
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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University of Dayton
OTHER
Eastern Kentucky University
OTHER
Responsible Party
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ANNE FLEISCHER
Professor
Principal Investigators
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Anne Fleischer, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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References
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Du 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.
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Hong 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.
Hoybye 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.
Lindahl-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.
Lyons 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.
Ma 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.
Mishra 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.
Silver 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.
Owen 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.
Salzer 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.
Smith 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.
Yun YH, Lee KS, Kim YW, Park SY, Lee ES, Noh DY, Kim S, Oh JH, Jung SY, Chung KW, Lee YJ, Jeong SY, Park KJ, Shim YM, Zo JI, Park JW, Kim YA, Shon EJ, Park S. Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial. J Clin Oncol. 2012 Apr 20;30(12):1296-303. doi: 10.1200/JCO.2011.37.2979. Epub 2012 Mar 12.
Zabit F, Iyigun G. A comparison of physical characteristics, functions and quality of life between breast cancer survivor women who had a mastectomy and healthy women. J Back Musculoskelet Rehabil. 2019;32(6):937-945. doi: 10.3233/BMR-181362.
Other Identifiers
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EasternKU
Identifier Type: -
Identifier Source: org_study_id
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