- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07643389
EXCEL-Punjabi: A Culturally Tailored Exercise Oncology Pilot Feasibility Intervention (EXCEL-Punjabi)
EXCEL-Punjabi: Tailored Exercise Oncology for the South Asian Population
The goal of this pilot feasibility study is to explore the feasibility and exploratory effects of a culturally-tailored exercise oncology intervention in Punjabi-speaking individuals of South Asian heritage and their support persons. The main questions it aims to answer are:
- What is the feasibility and acceptability of the EXCEL-Punjabi intervention?
- What are the exploratory effects (i.e., psychosocial and physical changes) before and after program delivery?
Participants will take part in a 12-week exercise oncology intervention consisting of twice weekly hour long multimodal circuit-based exercise sessions. They will also complete questionnaires and functional fitness assessments pre- and post- intervention.
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- Genesis Centre Calgary
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Punjabi-speaking
- Self-identified as being of South Asian heritage
- over the age of 18
- pre-, post-, or currently receiving cancer treatment or a support person of an individual living with and beyond cancer
- cleared to participate in, at minimum, mild intensity exercise by a Clinical Exercise Physiologist
- Able to provide informed consent
Exclusion Criteria:
- under the age of 18
- not cleared to exercise by a Clinical Exercise Physiologist
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: EXCEL-Punjabi
Culturally Tailored Exercise Oncology Intervention
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Culturally Tailored Exercise Oncology Intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Measurement Completion
Lasso di tempo: Baseline to the end of the intervention (12 weeks)
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Participants who completed all pre- and post- questionnaires and functional assessments
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Baseline to the end of the intervention (12 weeks)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Referrals
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Number of participants referred to intervention
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Baseline to end of intervention (12 weeks)
|
|
Consented
Lasso di tempo: Recruitment to end of intervention (12 weeks)
|
Number of participants who consented to participate in the intervention
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Recruitment to end of intervention (12 weeks)
|
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Enrolled
Lasso di tempo: Baseline (week 0)
|
Number of participants who enrolled (i.e. completed baseline assessments)
|
Baseline (week 0)
|
|
Attendance
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Intervention Attendance
|
Baseline to end of intervention (12 weeks)
|
|
Adverse Events
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Using the standardized Common Terminology Criteria for Adverse Events Version 6.0
|
Baseline to end of intervention (12 weeks)
|
|
Time Required to Deliver and Implement Intervention
Lasso di tempo: From recruitment to end of intervention (12 weeks)
|
Time requirement to deliver intervention
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From recruitment to end of intervention (12 weeks)
|
|
Physical Activity Level
Lasso di tempo: Baseline to end of intervention (12 weeks)
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The Godin Leisure Time Exercise Questionnaire is used to determine subjective levels of physical activity in each participant.
Participants report how many times per week they partake in mild, moderate, and/or strenuous exercise.
Higher scores indicate a more physically active lifestyle.
|
Baseline to end of intervention (12 weeks)
|
|
Cancer related symptoms
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Change in Edmonton Symptom Assessment Scale - revised: cancer.
Scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.
|
Baseline to end of intervention (12 weeks)
|
|
Health Related Quality of Life
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Change in EuroQual - 5Dimensions (EQ-5D) tool - first section is a questionnaire; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
|
Baseline to end of intervention (12 weeks)
|
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Fatigue
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale - scale is from 0-4, where 0 means "not at all" and 4 means "very much".
|
Baseline to end of intervention (12 weeks)
|
|
Cancer Related Quality of Life
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
A 5-point Likert scale (0 = not at all, to 4 = very much) to track wellbeing over the course of the cancer journey.
|
Baseline to end of intervention (12 weeks)
|
|
Exercise Barriers Self-Efficacy
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Exercise barriers and facilitators questionnaire
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Baseline to end of intervention (12 weeks)
|
|
Cognition
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Cancer related cognition using the Functional Assessment of Cancer Therapy - Cognition questionnaire.
A 37-item, self-report questionnaire used to evaluate how cancer patients perceive their own cognitive abilities
|
Baseline to end of intervention (12 weeks)
|
|
Aerobic Capacity
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
In-person participants will be assessed on change in 6-minute walk test (m) results
|
Baseline to end of intervention (12 weeks)
|
|
Aerobic Capacity
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Online participants will be assessed with change in the 2-minute step test (number of steps) results.
|
Baseline to end of intervention (12 weeks)
|
|
Lower body strength
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Change in sit-to-stand (number of repetitions in 30 seconds)
|
Baseline to end of intervention (12 weeks)
|
|
Upper extremity flexibility
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Change in active shoulder flexion range of motion (degrees)
|
Baseline to end of intervention (12 weeks)
|
|
Balance
Lasso di tempo: Baseline to end of intervention (12 weeks)
|
Change in one legged stance test (seconds)
|
Baseline to end of intervention (12 weeks)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- Cheifetz O, Park Dorsay J, Hladysh G, Macdermid J, Serediuk F, Woodhouse LJ. CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Psychooncology. 2014 Feb;23(2):204-15. doi: 10.1002/pon.3389. Epub 2013 Sep 6.
- Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
- Cormie P, Zopf EM, Zhang X, Schmitz KH. The Impact of Exercise on Cancer Mortality, Recurrence, and Treatment-Related Adverse Effects. Epidemiol Rev. 2017 Jan 1;39(1):71-92. doi: 10.1093/epirev/mxx007.
- McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975.
- King-Shier K, Lau A, Fung S, LeBlanc P, Johal S. Ethnocultural influences in how people prefer to obtain and receive health information. J Clin Nurs. 2018 Apr;27(7-8):e1519-e1528. doi: 10.1111/jocn.14281. Epub 2018 Mar 30.
- Loeb S, Borno HT, Gomez S, Ravenell J, Myrie A, Sanchez Nolasco T, Byrne N, Cole R, Black K, Stair S, Macaluso JN, Walter D, Siu K, Samuels C, Kazemi A, Crocker R, Sherman R, Wilson G, Griffith DM, Langford AT. Representation in Online Prostate Cancer Content Lacks Racial and Ethnic Diversity: Implications for Black and Latinx Men. J Urol. 2022 Mar;207(3):559-564. doi: 10.1097/JU.0000000000002257. Epub 2022 Feb 4.
- Bhandari D, Ozaki A, Kobashi Y, Higuchi A, Shakya P, Tanimoto T. Cancer information seeking and scanning behavior among Nepalese migrants in Japan and its association with preventive behavior. PLoS One. 2020 Jun 29;15(6):e0235275. doi: 10.1371/journal.pone.0235275. eCollection 2020.
- Caperchione CM, Chau S, Walker GJ, Mummery WK, Jennings C. Gender-Associated Perceptions of Barriers and Motivators to Physical Activity Participation in South Asian Punjabis Living in Western Canada. J Phys Act Health. 2015 May;12(5):686-93. doi: 10.1123/jpah.2013-0208. Epub 2013 Aug 7.
- Wagoner CW, Dreger J, Keats MR, Santa Mina D, McNeely ML, Cuthbert C, Capozzi LC, Francis GJ, Trinh L, Sibley D, Langley J, Chiekwe J, Ester M, Foucaut AM, Culos-Reed SN. First-Year Implementation of the EXercise for Cancer to Enhance Living Well (EXCEL) Study: Building Networks to Support Rural and Remote Community Access to Exercise Oncology Resources. Int J Environ Res Public Health. 2023 Jan 20;20(3):1930. doi: 10.3390/ijerph20031930.
- Heston AH, Schwartz AL, Justice-Gardiner H, Hohman KH. Addressing physical activity needs of survivors by developing a community-based exercise program: LIVESTRONG(R) at the YMCA. Clin J Oncol Nurs. 2015 Apr;19(2):213-7. doi: 10.1188/15.CJON.213-217.
- Haas BK, Kimmel G, Hermanns M, Deal B. Community-based FitSTEPS for life exercise program for persons with cancer: 5-year evaluation. J Oncol Pract. 2012 Nov;8(6):320-4, 2 p following 324. doi: 10.1200/JOP.2012.000555. Epub 2012 Jul 24.
- Leach HJ, Danyluk JM, Nishimura KC, Culos-Reed SN. Evaluation of a Community-Based Exercise Program for Breast Cancer Patients Undergoing Treatment. Cancer Nurs. 2015 Nov-Dec;38(6):417-25. doi: 10.1097/NCC.0000000000000217.
- Leach HJ, Danyluk JM, Culos-Reed SN. Design and implementation of a community-based exercise program for breast cancer patients. Curr Oncol. 2014 Oct;21(5):267-71. doi: 10.3747/co.21.2079.
- Culos-Reed N, Wagoner CW, Dreger J, McNeely ML, Keats M, Santa Mina D, Cuthbert C, Capozzi LC, Francis GJ, Chen G, Ester M, McLaughlin E, Eisele M, Sibley D, Langley J, Chiekwe J, Christensen T; EXCEL Project Team. Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). BMJ Open. 2022 Dec 29;12(12):e063953. doi: 10.1136/bmjopen-2022-063953.
- Hardcastle SJ, Cohen PA. Effective Physical Activity Promotion to Survivors of Cancer Is Likely to Be Home Based and to Require Oncologist Participation. J Clin Oncol. 2017 Nov 10;35(32):3635-3637. doi: 10.1200/JCO.2017.74.6032. Epub 2017 Sep 15. No abstract available.
- Bansal M, Rana B, Ghotra H, King-Shier K, Bridel W, Culos-Reed SN. Exploring physical activity experiences, barriers, and facilitators among individuals of South Asian heritage living with and beyond cancer. Ethn Health. 2023 Nov;28(8):1085-1102. doi: 10.1080/13557858.2023.2224951. Epub 2023 Jun 14.
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Altri numeri di identificazione dello studio
- HREBA.CC-25-0150
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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