NCT03045575|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · University of California, San Francisco
observational
65
1 country
1
Study Start
August 2, 2016
Actual (reported)Primary Completion
January 18, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)This is a prospective observational study designed to determine the feasibility and acceptability of objectively measuring physical activity, sedentary time, and sleep using the Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and are planning to initiate chemotherapy will be invited to participate in this study, and we will measure general and breast-specific quality-of-life using Patient-Reported Outcomes Measurement Information System (PROMIS) measures for 3-6 months after completion of chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2, 2016
Actual (reported)January 27, 2017
Actual (reported)February 7, 2017
Actual (reported)January 18, 2018
Actual (reported)December 31, 2018
Actual (reported)Adherence
Adherence, defined at the percentage of weeks that a participant successfully syncs their Fitbit at least once a week during the course of the study, will be reported as a point estimate and 95% confidence interval
9 months
Quality of Life - Physical Function
Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Quality of Life - Anxiety
Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Quality of Life - Depression
Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Quality of Life - Fatigue
Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Quality of Life - Applied cognition general concerns
Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Potentially eligible patients who are planning to initiate chemotherapy for breast cancer will be identified through the Breast Care Clinic. Our power calculation is based on the proportion of patients who successfully complete the study, defined as ≥70% of participants wearing the Fitbit and completing the post-chemotherapy follow-up assessment. Using a 1-sided 1-sample binomial test with α = 0.05, 50 patients, an expected successful completion proportion of 70%, we will have 80% power to reject the null hypothesis if 53% or fewer participants successfully complete the protocol. In other words, the intervention will be considered feasible if 27 or more participants in complete the protocol.
University of California, San Francisco
San Francisco, California, 94143, United States
Irwin ML, Crumley D, McTiernan A, Bernstein L, Baumgartner R, Gilliland FD, Kriska A, Ballard-Barbash R. Physical activity levels before and after a diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003 Apr 1;97(7):1746-57. doi: 10.1002/cncr.11227.
DeSantis CE, Lin CC, Mariotto AB, Siegel RL, Stein KD, Kramer JL, Alteri R, Robbins AS, Jemal A. Cancer treatment and survivorship statistics, 2014. CA Cancer J Clin. 2014 Jul-Aug;64(4):252-71. doi: 10.3322/caac.21235. Epub 2014 Jun 1.
Michelle Melisko, MD
University of California, San Francisco
65 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2017
First Posted
February 7, 2017
Study Start
August 2, 2016
Actual (reported)Integrative Approaches to Cancer Survivorship: Project 3
Contact the study team to confirm eligibility.
Byar KL, Berger AM, Bakken SL, Cetak MA. Impact of adjuvant breast cancer chemotherapy on fatigue, other symptoms, and quality of life. Oncol Nurs Forum. 2006 Jan 1;33(1):E18-26. doi: 10.1188/06.ONF.E18-E26.
Demark-Wahnefried W, Peterson BL, Winer EP, Marks L, Aziz N, Marcom PK, Blackwell K, Rimer BK. Changes in weight, body composition, and factors influencing energy balance among premenopausal breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2001 May 1;19(9):2381-9. doi: 10.1200/JCO.2001.19.9.2381.
de Jong N, Courtens AM, Abu-Saad HH, Schouten HC. Fatigue in patients with breast cancer receiving adjuvant chemotherapy: a review of the literature. Cancer Nurs. 2002 Aug;25(4):283-97; quiz 298-9. doi: 10.1097/00002820-200208000-00004.
Schwartz AL. Exercise and weight gain in breast cancer patients receiving chemotherapy. Cancer Pract. 2000 Sep-Oct;8(5):231-7. doi: 10.1046/j.1523-5394.2000.85007.x.
Kroenke CH, Chen WY, Rosner B, Holmes MD. Weight, weight gain, and survival after breast cancer diagnosis. J Clin Oncol. 2005 Mar 1;23(7):1370-8. doi: 10.1200/JCO.2005.01.079. Epub 2005 Jan 31.
Schwartz AL, Mori M, Gao R, Nail LM, King ME. Exercise reduces daily fatigue in women with breast cancer receiving chemotherapy. Med Sci Sports Exerc. 2001 May;33(5):718-23. doi: 10.1097/00005768-200105000-00006.
Anderson RT, Kimmick GG, McCoy TP, Hopkins J, Levine E, Miller G, Ribisl P, Mihalko SL. A randomized trial of exercise on well-being and function following breast cancer surgery: the RESTORE trial. J Cancer Surviv. 2012 Jun;6(2):172-81. doi: 10.1007/s11764-011-0208-4. Epub 2011 Dec 10.
Courneya KS, Segal RJ, McKenzie DC, Dong H, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Crawford JJ, Mackey JR. Effects of exercise during adjuvant chemotherapy on breast cancer outcomes. Med Sci Sports Exerc. 2014 Sep;46(9):1744-51. doi: 10.1249/MSS.0000000000000297.
Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.
Chasan-Taber S, Rimm EB, Stampfer MJ, Spiegelman D, Colditz GA, Giovannucci E, Ascherio A, Willett WC. Reproducibility and validity of a self-administered physical activity questionnaire for male health professionals. Epidemiology. 1996 Jan;7(1):81-6. doi: 10.1097/00001648-199601000-00014.
Primary Completion
January 18, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Last Updated
July 2, 2020
Record last verified: 2020-06
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