Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

NCT03045575 | Completed

• 2 other identifiers: 15751215-17054
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• have been diagnosed with breast cancer
• be planning to initiate chemotherapy for breast cancer at University of California, San Francisco (UCSF)
• be able to speak and read English, or have a family member or friend who can assist in translating and completing surveys in English
• be able to walk unassisted
• be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet

You may not qualify if:

• We will exclude individuals who cannot speak or read English unless they have a friend or family member who can assist in translating and completing quality of life surveys in English. In addition, the Fitbit® requires the ability to connect to the Internet and input data in a website, therefore we will exclude patients with no regular access to the Internet or who are unable to fill out forms on the web or navigate websites. We will exclude patients who are unable to walk unassisted.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (12)

• 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.

  PMID: 12655532 BACKGROUND

• 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.

  PMID: 24890451 BACKGROUND

• 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.

  PMID: 16470230 BACKGROUND

• 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.

  PMID: 11331316 BACKGROUND

• 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.

  PMID: 12181497 BACKGROUND

• 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.

  PMID: 11898235 BACKGROUND

• 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.

  PMID: 15684320 BACKGROUND

• 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.

  PMID: 11323538 BACKGROUND

• 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.

  PMID: 22160629 BACKGROUND

• 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.

  PMID: 24633595 BACKGROUND

• 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.

  PMID: 20411366 BACKGROUND

• 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.

  PMID: 8664406 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michelle Melisko, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 7, 2017
• Study Start: August 2, 2016
• Primary Completion: January 18, 2018
• Study Completion: December 31, 2018
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)