Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045575
• Other study ID #: 157512
• Secondary ID: 15-17054
• Status: Completed
• Start date: August 2, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Over 3.1 million women are currently living with a diagnosis of breast cancer in the United States (US), representing 41% of all female cancer survivors in the US. The increased breast cancer survival rate has necessitated a shift in cancer care toward developing interventions to empower patients to improve their quality-of-life, and perhaps prognosis, during and after treatment. Among women diagnosed with early-stage (I or II) breast cancer, around 40% will receive chemotherapy. Among women diagnosed with late-stage (III or IV), around 75% will receive chemotherapy. Adjuvant chemotherapy is associated with many side effects, including fatigue, nausea, disturbed sleep, decreased activity, and weight gain. Women receiving chemotherapy gain an average of 2.5 to 6.2 kg during therapy. Weight gain increases the risk of breast cancer recurrence and mortality, as well as cardiovascular disease, diabetes, and second primary cancers. Physical activity alleviates or reduces both short and long term treatment side effects of chemotherapy, including weight gain, and restores physical functioning in breast cancer patients. Additionally, randomized controlled trials in breast cancer patients have shown that adding exercise to chemotherapy programs can improve breast cancer outcomes.

Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. Existing research has relied on self-reported activity levels, which is a poor measure of low-intensity activities and can only capture a periodic snap shot of activity levels. This study will provide objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent physical activity declines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Jan 31. — View Citation

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. — View Citation

Schwartz AL. Exercise and weight gain in breast cancer patients receiving chemotherapy. Cancer Pract. 2000 Sep-Oct;8(5):231-7. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life - Physical Function	Mean of PROMIS physical functioning questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Anxiety	Mean of PROMIS anxiety questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Depression	Mean of PROMIS depression questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Fatigue	Mean of PROMIS fatigue questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Applied cognition general concerns	Mean of PROMIS applied cognition general concerns questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Social roles	Mean of PROMIS social roles questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Applied cognitive abilities	Mean of PROMIS applied cognitive abilities questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	12 months from start of chemotherapy
Secondary	Quality of Life - Sleep disturbance	Mean of PROMIS sleep disturbance questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Sleep-related impairment	Mean of PROMIS sleep-related impairment questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Pain interference	Mean of PROMIS pain interference questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Quality of Life - Exercise Vital Sign	Mean of the Exercise Vital Sign (A patient reported measure of the average minutes of moderate or greater physical activity they engage in per week) at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported.	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.
Secondary	Body Size	Body mass index (BMI) will be calculated at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and at 6 months following chemotherapy.	Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.