Titre officiel
Technology to Support Exercise Adherence in Project EXCEL Participants
Sommaire:
Adhésion et maintien de l’exercice dans le programme EXCEL avec l’aide
d’une application pour téléphone intelligent : un essai pilote contrôlé à
répartition aléatoire
Description de l'essai
Primary Outcome:
- Objective Physical Activity Minutes Per Week
- Subjective Physical Activity Minutes Per Week
- EXCEL class attendance
Secondary Outcome:
- ZI application usage
- Participant Satisfaction
- Body Composition
- Aerobic Endurance
- Upper extremity grip strength
- Functional performance test
- Upper extremity flexibility
- Lower extremity flexibility
- Balance
- Cancer related symptoms
- General Health-related Quality of Life
- Fatigue
- General well-being
- Cognition
- Barriers and facilitators to exercise participation
- Exercise adherence
- Participant perceptions of using the ZI application
Purpose:
The primary aim of this proposed pilot randomized controlled trial is
to investigate the effectiveness and patterns of use of a mHealth
application (ZoeInsights - ZI) for supporting physical activity (PA)
maintenance in remote and rural cancer survivors within an
online-delivered exercise oncology program (Project EXCEL; ethics
HREBA-CC.20-0098).
Background/Rationale:
Evidence indicates mixed effectiveness for online-delivered exercise
oncology programs to improve physical activity (PA) behaviour, especially
with regards to maintenance of PA behaviour post-intervention.
Supportive resources are needed, especially for remote/rural cancer
survivors who may have lower social support, PA self-efficacy,
motivation, as well as unique barriers to PA. Mobile health technology
(mHealth) has potential to support PA behaviour change in cancer
survivors, but evidence for its impact and best implementation practices
in exercise oncology remains limited. Prior findings on PA behavior
change suggest that in order to elicit lasting effects, early
integration of supportive resources (eg. self-monitoring via a mhealth
app) within PA participation is important. And in particular, research
is needed to determine the effectiveness of mHealth within exercise
oncology programs for supporting long-term PA maintenance. No studies on
mhealth exercise interventions have been carried out in remote/rural
cancer survivors.
Objectives: Primary aim
is to assess the effectiveness of the mhealth app, ZI for supporting
maintenance of PA behaviour change, up to 24-weeks from program
initiation. The impact of the ZI intervention on PA behaviour change
will be measured by weekly objectively measured minutes of moderate to
vigorous physical activity (MVPA), subjectively reported weekly minutes
of MVPA, and program attendance. The investigators hypothesize the ZI
intervention group will have improved maintenance of PA behaviour change
at 24-weeks compared to those in EXCEL only group. The secondary
outcomes aim to assess the extent of use of the application. This will
be assessed by app usage, satisfaction reports, and the participants
perspectives on the continued use of the ZI application. The
investigators hypothesize that majority of users will download and
continue to use the application throughout the 24-week study period.
Methods:
Participants and
Recruitment All EXCEL participants will be eligible to participate in
the proposed sub-study, including those who may already be using
PA-related apps. Email invitations will be sent to eligible participants
with a study overview, instructions on who to contact to answer
questions, and a link to complete the informed consent form in the EXCEL
RedCap database if they are interested in participating. The consent
form will require an electronic signature. It will be marked as complete
in RedCap as soon as all required fields are completed and the
participant submits the form. After completion of recruitment,
randomization using a random number generator, with odd numbers assigned
to the intervention (EXCEL + ZI at baseline) and even numbers to the
waitlist control (EXCEL + ZI at 24 weeks) group. Randomization will
occur by clusters so that all participants in the same exercise class
day and time will be assigned to the intervention or waitlist control
group. This will be done to enhance the integration of ZoeInsights
within the EXCEL program.
To participate in EXCEL,
participants must 1) have a cancer diagnosis; 2) be over the age of 18
years; 3) be able to participate in mild levels of activity as a minimum
(to be assessed during screening via the Physical Activity Readiness
Questionnaire); 4) be pre-treatment, or receiving active cancer
treatment, or have received cancer treatment within the past three
years; 5) be able to provide informed written consent in English; and 6)
have access to internet service that can support video calling. All
EXCEL participants live in rural or remote locations in Canada. The
inclusion criteria ensures the investigators reach a wide range of
cancer survivors throughout various stages of their journey while
ensuring they are physically capable of safely completing exercise.
Participants will be eligible regardless of cancer type and stage and
there are no aims to recruit specific cancer survivors. No
stratification for treatment status will occur.
Study Design/Procedure
The proposed study will be a prospective, 2-arm, pilot randomized
controlled trial with waitlist control arm. Participants randomized to
the intervention will receive access to the ZI application for the
duration of the study. Those in the waitlist control group will be able
to download and use ZI after completing the 24-week assessment. All
participants will take part in the standard 12-week group-based EXCEL
online exercise program. Garmin wearable PA trackers will be provided to
all participants to objectively track PA habits throughout the
intervention.
Intervention
The ZI App:
ZI is designed to
promote PA behavior change and maintenance via self-monitoring of
physical activity, symptoms, and other health data. Furthermore,
self-monitoring is intended to facilitate participant understanding of
and communication about their PA and health with caregivers, exercise
professionals, and healthcare professionals. Additional information for
using ZI will be provided via a PDF-based user guide on installing and
using the application, a live instructional webinar hosted by ZI
developer Hanalytics Solutions, and access to continued support via
email/telephone communication with study staff as well as Hanalytics
Solutions. After completing initial set-up, participants will be asked
to record physical activity and symptoms regularly via scheduled in-app
routines. Reminders to complete these self-monitoring tasks will be
provided using daily push notifications scheduled according to
participant preferences. Automatic graphs will be generated and
displayed within the app to allow participants to visualize trends in
physical activity, symptoms, and other health data. Further use of ZI
(eg. Custom daily routines, additional graphing, medication tracking,
accessing linked health resources) during the intervention will be
possible ad libitum.
ZI can be accessed via a
web browser on any device that is connected to the internet (e.g.
computer, laptop, tablet, smartphone), or via a native android or iOS
mobile application on a smartphone or tablet. No devices will be
provided to participants, as participants are already required to own an
internet-connected device for email communication and completion of
study measures online in RedCap.
The EXCEL online exercise program:
The EXCEL exercise
program is based on the Alberta Cancer Exercise (ACE) program
(HREBA.CC-16-0905), adapted as required for rural/remote site
implementation. The exercise program includes a combination of aerobic,
resistance, balance, and flexibility exercises delivered in a
circuit-type class setting or group personal training format, twice
weekly for a 8-12 week period. The exercise sessions will be conducted
online in small groups of 8-15 participants under the direct supervision
of a trained qualified exercise professional (QEP). The sessions will
be conducted over the Zoom platform and the QEP will be provided
additional support from the central research team, including moderators
for sessions. The exercises will be slightly modified to ensure safety
of all participants is maintained, based on current ACE online delivery.
The program follows exercise progression principles (ie, principles of
frequency, intensity, time, type, overload and progression) over the
8-12-weeks, with tailoring of any exercise to meet individual
participant needs as required, in order to promote fitness and wellness
benefits.
Timing Participants will
complete the baseline assessment, including EXCEL and
sub-study-specific questionnaires and baseline physical function
assessment, prior to EXCEL class start (T0). They will then be given
access, within the first two weeks of EXCEL, to the ZI application along
with the ZI user guide and invitation to the instructional webinar to
facilitate installation, set-up, and familiarization with ZI. Upon
program start, participants will attend twice-weekly group-based EXCEL
exercise classes and use ZI as outlined above to self-monitor PA and
health. The study will consist of 2 phases, the intervention phase
(EXCEL classes + ZI) from week 0-12, followed by the maintenance phase
from weeks 12-24 (ZI only). Outcome measures will be collected at 3
subsequent time points: week 4 (T1), week 12 (T2), and week 24 (T3).
Measures Demographics
(T0) Participant demographics will be collected within EXCEL.
Additionally, participants will be asked to complete a set of
questionnaires to assess prior technology usage, familiarity, and
literacy.
Physical Activity
(T0-T3) To examine effectiveness of ZI to support PA habits and
maintenance, PA will be assessed via self-report at all time points
(T0-T3) using the Godin Leisure Time Exercise Questionnaire (GLTEQ) and
objectively throughout the intervention using the accelerometer
(continued reporting of objective PA via Garmin after T2 is optional).
In addition, class attendance (weeks 1-12) will be recorded.
Patterns of ZI use
(T1-T3) App usage data will be collected directly via ZI, including
logins, tasks completed, pages visited, additional use, and continued
usage habits during the maintenance phase. User satisfaction with ZI as
well as usability will be assessed using the validated mobile app
usability questionnaire (MAUQ). Additional data collected includes error
reporting/technical difficulties and costs of providing ZI per
participant (subscription fee and support hours required). Participant
perceptions of using the ZI application will be examined via qualitative
semi-structured interviews.
Qualitative Interviews
(T2-T3) A purposive sample of participants from the intervention group
(n=10-20) will be invited to participate in semi-structured one-on-one
interviews at 12 and 24 weeks. Interviews will focus on participant
perspectives of using the ZI app as well as its usefulness for
supporting PA behavior change and maintenance. An interview guide was
developed by researchers with open-ended questions that are designed to
guide the discussion while allowing the participant voice to dictate the
flow of their interview. Purposive sampling will be used to ensure that
participants from various demographic backgrounds are represented,
giving consideration to age, gender, cancer diagnosis (type, stage, time
since diagnosis), and baseline technology use.
EXCEL Study Measures
(T0, T2, T3) As part of the EXCEL study, participants will complete a
online physical function assessment with a clinical exercise
physiologist (CEP). The CEP will assess resting health measures (heart
rate, blood pressure, height, weight) as well as measures of
flexibility, strength, and endurance via standardized tests. EXCEL
participants will also complete questionnaires assessing symptom burden
(Edmonton Symptom Assessment Scale), quality of life (Functional
Assessment of Cancer Therapy - General and Cognitive subscales), fatigue
(Functional Assessment of Chronic Illness Therapy - Fatigue subscale),
and exercise barriers and facilitators (Exercise Barriers and
Facilitators questionnaire developed for ACE).
Sample Size The sample
size calculation is based on the primary outcome of assessing
intervention effectiveness for supporting PA maintenance. A total sample
of 140 (70 per group) provides at least 80% power to detect a
between-group difference in PA of 60 minutes per week (including any PA
from mild housework to strenuous training) with a two-tailed alpha of
5%, allowing for 10% attrition over the intervention period. The
investigators do not anticipate that the second wave of EXCEL (Winter
2020) will recruit more than 60-80 participants, thus the investigators
will collect data over at least two waves. Preliminary analyses on
feasibility, and any changes required, would be made at the end of
Spring 2021 session (i.e., July 2021), and put into place for Fall 2021
participants.
Data Analysis
Participant baseline characteristics and patterns of use will be
summarized using descriptive statistics. To investigate within and
between-group differences at all time points, random effects linear
mixed models will be used. The models will be controlled for potential
demographic confounders (age, gender, cancer type, treatment status, and
others). Primary analyses will follow intention-to-treat principles,
with exploratory subgroup analyses based on actual ZI usage (i.e.
completion of routines and other self-monitoring). Qualitative
interviews will be transcribed verbatim and analyzed according to
interpretive description methodology based on a constructivist
philosophy.
Voir cet essai sur ClinicalTrials.gov
