Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study
Background: Treatment-related serious adverse events (SAEs) are common in patients receiving intravesical Bacillus Calmette-Guerin (BCG) for the treatment of high-risk nonmuscle-invasive bladder cancer (NMIBC). Here we describe the protocol of a randomized, attention/waitlist-controlled feasibility...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422001612 |
| _version_ | 1811294399616778240 |
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| author | Sarah P. Psutka Susan Veleber Jonathan Siman Samia Jannat Sarah Holt Jonathan L. Wright Heather Greenlee |
| author_facet | Sarah P. Psutka Susan Veleber Jonathan Siman Samia Jannat Sarah Holt Jonathan L. Wright Heather Greenlee |
| author_sort | Sarah P. Psutka |
| collection | DOAJ |
| description | Background: Treatment-related serious adverse events (SAEs) are common in patients receiving intravesical Bacillus Calmette-Guerin (BCG) for the treatment of high-risk nonmuscle-invasive bladder cancer (NMIBC). Here we describe the protocol of a randomized, attention/waitlist-controlled feasibility pilot study testing the use of acupuncture to decrease SAEs and treatment interruptions in this population. The primary objectives are to evaluate the feasibility and efficacy of conducting pre-procedure acupuncture in a Urology Clinic. Methods: A total of 45 patients will be recruited and randomized in a 2:1 ratio (treatment arm: attention/waitlist control). Eligibility criteria include 1) age 18 years or older, 2) English-speaking, 3) high-risk NMIBC, 4) no acupuncture in the previous 3 months, and 5) willing and able to participate in trial activities. Patients in the treatment arm will receive acupuncture prior to weekly BCG for a total of six weeks. Methods were developed to train and monitor research acupuncturists and included online and in-person training, study manuals, and monthly meetings throughout the study period. Feasibility assessments include evaluation of the recruitment, retention and protocol adherence to acupuncture treatment, and measurement of CTCAE v5.0 adverse events specific to acupuncture, and clinic staff surveys regarding the intervention impact on clinic workflow. Efficacy measures will be compared between treatment and control groups including: EORTC-QLQ-NMIBC-24, EORTC-QLQ-C30, CTCAE v5.0, medication journal, healthcare utilization, current use of complementary, alternative, and integrative therapies, and acupuncture expectancy and treatment preference. Trial results will inform the design of a multi-center trial to expand testing of the protocol to a larger patient cohort. |
| first_indexed | 2024-04-13T05:17:00Z |
| format | Article |
| id | doaj.art-d7386dc3beaf4473bf01166b078f84f3 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-13T05:17:00Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-d7386dc3beaf4473bf01166b078f84f32022-12-22T03:00:52ZengElsevierContemporary Clinical Trials Communications2451-86542022-12-0130101044Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility studySarah P. Psutka0Susan Veleber1Jonathan Siman2Samia Jannat3Sarah Holt4Jonathan L. Wright5Heather Greenlee6Department of Urology, University of Washington School of Medicine, United States; Corresponding author. 1959 NE Pacific Street, Box 356510, Seattle, WA, 98195, United States.Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, United States; Division of Public Health Sciences, Fred Hutchinson Cancer Center, United StatesIntegrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, United States; Division of Public Health Sciences, Fred Hutchinson Cancer Center, United StatesDepartment of Urology, University of Washington School of Medicine, United StatesDepartment of Urology, University of Washington School of Medicine, United States; Clinical Research Division, Fred Hutchinson Cancer Center, United StatesDepartment of Urology, University of Washington School of Medicine, United States; Division of Public Health Sciences, Fred Hutchinson Cancer Center, United States; Clinical Research Division, Fred Hutchinson Cancer Center, United StatesIntegrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, United States; Division of Public Health Sciences, Fred Hutchinson Cancer Center, United States; Clinical Research Division, Fred Hutchinson Cancer Center, United States; Division of Medical Oncology, Department of Medicine, University of Washington School of Medicine, United StatesBackground: Treatment-related serious adverse events (SAEs) are common in patients receiving intravesical Bacillus Calmette-Guerin (BCG) for the treatment of high-risk nonmuscle-invasive bladder cancer (NMIBC). Here we describe the protocol of a randomized, attention/waitlist-controlled feasibility pilot study testing the use of acupuncture to decrease SAEs and treatment interruptions in this population. The primary objectives are to evaluate the feasibility and efficacy of conducting pre-procedure acupuncture in a Urology Clinic. Methods: A total of 45 patients will be recruited and randomized in a 2:1 ratio (treatment arm: attention/waitlist control). Eligibility criteria include 1) age 18 years or older, 2) English-speaking, 3) high-risk NMIBC, 4) no acupuncture in the previous 3 months, and 5) willing and able to participate in trial activities. Patients in the treatment arm will receive acupuncture prior to weekly BCG for a total of six weeks. Methods were developed to train and monitor research acupuncturists and included online and in-person training, study manuals, and monthly meetings throughout the study period. Feasibility assessments include evaluation of the recruitment, retention and protocol adherence to acupuncture treatment, and measurement of CTCAE v5.0 adverse events specific to acupuncture, and clinic staff surveys regarding the intervention impact on clinic workflow. Efficacy measures will be compared between treatment and control groups including: EORTC-QLQ-NMIBC-24, EORTC-QLQ-C30, CTCAE v5.0, medication journal, healthcare utilization, current use of complementary, alternative, and integrative therapies, and acupuncture expectancy and treatment preference. Trial results will inform the design of a multi-center trial to expand testing of the protocol to a larger patient cohort.http://www.sciencedirect.com/science/article/pii/S2451865422001612Intravesical bacillus calmette-guerinBCGHigh-risk nonmuscle-invasive bladder cancerAcupuncture |
| spellingShingle | Sarah P. Psutka Susan Veleber Jonathan Siman Samia Jannat Sarah Holt Jonathan L. Wright Heather Greenlee Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study Contemporary Clinical Trials Communications Intravesical bacillus calmette-guerin BCG High-risk nonmuscle-invasive bladder cancer Acupuncture |
| title | Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study |
| title_full | Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study |
| title_fullStr | Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study |
| title_full_unstemmed | Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study |
| title_short | Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study |
| title_sort | effects of acupuncture to decrease adverse events in patients with high risk non muscle invasive bladder cancer receiving induction intravesical bcg therapy study protocol for a randomized controlled pilot and feasibility study |
| topic | Intravesical bacillus calmette-guerin BCG High-risk nonmuscle-invasive bladder cancer Acupuncture |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422001612 |
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