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| Name | Class |
|---|---|
| University of Dayton | OTHER |
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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.
Setting: Virtual environment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Other | 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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' | Change from baseline measure at 8 weeks |
| FACIT-Fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum heart rate and target heart rate range | The investigator will calculate the participant's maximum heart rate using the formula 207-.70(age)= maximum heart rate. The prescribed exercise intensity will be based on this calculation. The investigator will then instruct the participant on how to measure their heart rate to monitor their exercise intensity during exercise. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Fleischer, Ph.D | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bronfenbrenner U. Toward an experimental ecology of human development. American Psychologist. 1977. 32: 513-531 | ||
| 24891116 | Background | 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. | |
| 26072422 |
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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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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Change from 4 week measure at 8 weeks |
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
| 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. | 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. | 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 | 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 | 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. | 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. | Change from 4 week measure to 8 weeks |
| Background |
| 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. |
| 17468581 | Background | Gellish 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. |
| 20821373 | Background | Hegel 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. |
| 21798685 | Background | 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. |
| 20424614 | Background | 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. |
| 25580840 | Background | 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. |
| 29426388 | Background | 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. |
| 32920423 | Background | 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. |
| 22895961 | Background | 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. |
| 24125901 | Background | 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. |
| 16097906 | Background | 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. |
| 19484712 | Background | 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. |
| 27857248 | Background | 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. |
| 22412149 | Background | 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. |
| 31282398 | Background | 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. |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |