PMID- 33890857
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 4
DP  - 2021 Apr 23
TI  - A Technology-Based Physical Activity Intervention for Patients With Metastatic 
      Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial.
PG  - e24254
LID - 10.2196/24254 [doi]
LID - e24254
AB  - BACKGROUND: Increased incidence and life expectancy have resulted in a growing 
      population of patients with metastatic breast cancer, and these patients 
      experience high rates of morbidity and premature mortality. Increased physical 
      activity (PA) is consistently associated with improved health and disease 
      outcomes among early-stage survivors. However, there is a paucity of research on 
      PA in patients with metastatic breast cancer, and existing PA interventions have 
      exhibited low feasibility because of their focus on intense PA and/or requirement 
      of on-site visits. Mobile health (mHealth)-based PA interventions may be 
      particularly useful for patients with metastatic breast cancer because they allow 
      for remote monitoring, which facilitates individual tailoring of PA 
      recommendations to patients' abilities and may minimize participant burden. 
      However, no studies have examined mHealth PA interventions in patients with 
      metastatic breast cancer. OBJECTIVE: We aim to address these critical research 
      gaps by testing a highly tailored technology-based intervention to promote PA of 
      any intensity (ie, light, moderate, or vigorous) by increasing daily steps in 
      patients with metastatic breast cancer. The primary aim of this study is to test 
      the feasibility and acceptability of the Fit2ThriveMB intervention. We will also 
      examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom 
      burden, quality of life, and functional performance. METHODS: The Fit2ThriveMB 
      trial is a two-arm pilot randomized controlled trial that will compare the 
      effects of a smartphone-delivered, home-based PA intervention and an 
      attention-control education condition on PA and quality of life in low-active 
      female patients with metastatic breast cancer. A subsample (n=25) will also 
      complete functional performance measures. This innovative trial will recruit 50 
      participants who will be randomized into the study's intervention or control arm. 
      The intervention will last 12 weeks. The Fit2ThriveMB intervention consists of a 
      Fitbit, coaching calls, and the Fit2ThriveMB smartphone app that provides 
      self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app 
      notifications, and a group message board. Assessments will occur at baseline and 
      post intervention. RESULTS: The Fit2ThriveMB study is ongoing. Data collection 
      ended in February 2021. CONCLUSIONS: Data from this study will provide the 
      preliminary effect sizes needed to assemble an intervention that is to be 
      evaluated in a fully powered trial. In addition, these data will provide 
      essential evidence to support the feasibility and acceptability of using a 
      technology-based PA promotion intervention, a scalable strategy that could be 
      easily integrated into care, among patients with metastatic breast cancer. TRIAL 
      REGISTRATION: ClinicalTrials.gov NCT04129346; 
      https://clinicaltrials.gov/ct2/show/NCT04129346. INTERNATIONAL REGISTERED REPORT 
      IDENTIFIER (IRRID): DERR1-10.2196/24254.
CI  - (c)Siobhan Phillips, Payton Solk, Whitney Welch, Lisa Auster-Gussman, Marilyn Lu, 
      Erin Cullather, Emily Torre, Madelyn Whitaker, Emily Izenman, Jennifer La, 
      Jungwha Lee, Bonnie Spring, William Gradishar. Originally published in JMIR 
      Research Protocols (https://www.researchprotocols.org), 23.04.2021.
FAU - Phillips, Siobhan
AU  - Phillips S
AUID- ORCID: 0000-0001-8899-3825
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Solk, Payton
AU  - Solk P
AUID- ORCID: 0000-0002-4887-2532
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Welch, Whitney
AU  - Welch W
AUID- ORCID: 0000-0002-1420-3090
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Auster-Gussman, Lisa
AU  - Auster-Gussman L
AUID- ORCID: 0000-0002-3294-1708
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Lu, Marilyn
AU  - Lu M
AUID- ORCID: 0000-0003-2568-7841
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Cullather, Erin
AU  - Cullather E
AUID- ORCID: 0000-0002-6813-764X
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Torre, Emily
AU  - Torre E
AUID- ORCID: 0000-0002-6915-4150
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Whitaker, Madelyn
AU  - Whitaker M
AUID- ORCID: 0000-0002-6532-1898
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Izenman, Emily
AU  - Izenman E
AUID- ORCID: 0000-0002-4687-4024
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - La, Jennifer
AU  - La J
AUID- ORCID: 0000-0002-1622-4047
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Lee, Jungwha
AU  - Lee J
AUID- ORCID: 0000-0002-0806-0847
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Spring, Bonnie
AU  - Spring B
AUID- ORCID: 0000-0003-0692-9868
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
FAU - Gradishar, William
AU  - Gradishar W
AUID- ORCID: 0000-0002-2772-3140
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT04129346
GR  - K07 CA196840/CA/NCI NIH HHS/United States
GR  - R21 CA239130/CA/NCI NIH HHS/United States
GR  - UL1 TR001422/TR/NCATS NIH HHS/United States
PT  - Journal Article
DEP - 20210423
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8105756
OTO - NOTNLM
OT  - metastatic breast cancer
OT  - mobile phone
OT  - physical activity
OT  - randomized controlled trial
OT  - technology
COIS- Conflicts of Interest: None declared.
EDAT- 2021/04/24 06:00
MHDA- 2021/04/24 06:01
PMCR- 2021/04/23
CRDT- 2021/04/23 12:24
PHST- 2020/09/10 00:00 [received]
PHST- 2021/02/15 00:00 [accepted]
PHST- 2021/01/28 00:00 [revised]
PHST- 2021/04/23 12:24 [entrez]
PHST- 2021/04/24 06:00 [pubmed]
PHST- 2021/04/24 06:01 [medline]
PHST- 2021/04/23 00:00 [pmc-release]
AID - v10i4e24254 [pii]
AID - 10.2196/24254 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 Apr 23;10(4):e24254. doi: 10.2196/24254.