Improving Physical Functioning in Older Cancer Survivors Through Light-Intensity Physical Activity
Phase: NA
Conditions: Cancer Survivors
Sponsor: University of New Mexico

PROTOCOL TITLE: Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
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PROTOCOL TITLE:
Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
Short Title “Move for Your Health”
PRINCIPAL INVESTIGATOR:
Name
Cindy Blair
Department
Internal Medicine
Telephone Number
505-925-7907
Email Address
CiBlair@salud.unm.edu
VERSION NUMBER:
12
VERSION DATE:
20 July 2023
Table of Contents
1.0
Objectives ...................................................................................................................2
2.0
Background.................................................................................................................2
3.0
Inclusion and Exclusion Criteria ................................................................................3
4.0
Study-Wide Number of Subjects................................................................................7
5.0
Study-Wide Recruitment Methods .............................................................................7
6.0
Multi-Site Research ....................................................................................................7
7.0
Study Timeline............................................................................................................7
8.0
Study Endpoints..........................................................................................................8
9.0
Procedures Involved ...................................................................................................8
10.0
Data and Specimen Management ...........................................................................14
11.0
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................16
12.0
Withdrawal of Subjects...........................................................................................17
13.0
Risks to Subjects.....................................................................................................17
14.0
Potential Benefits to Subjects .................................................................................18
15.0
Vulnerable Populations...........................................................................................19
16.0
Community-Based Participatory Research.............................................................19
17.0
Setting.....................................................................................................................19
18.0
Resources Available ...............................................................................................19
19.0
Recruitment Methods..............................................................................................20
20.0
Number of Subjects ................................................................................................21
21.0
Provisions to Protect the Privacy Interests of Subjects ..........................................21
22.0
Compensation for Research-Related Injury............................................................21
23.0
Economic Burden to Subjects.................................................................................21
24.0
Consent Process......................................................................................................22
25.0
Process to Document Consent in Writing...............................................................22
26.0
Devices ...................................................................................................................22

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1.0
Objectives
Our objective is to examine the feasibility and acceptability of a home-based lifestyle activity 
intervention to promote light-intensity activity and reduce sedentary activity using a whole-of-day 
approach. Sixty-four older cancer survivors will be randomized to either a 12-week theory-based 
intervention or a waitlist control. The intervention uses a wearable activity tracker that pairs with 
a smartphone app to promote awareness and enable self-monitoring of both activity and inactivity. 
Motivational counseling will be used to individually tailor strategies to achieve goals. Data will be 
collected at baseline, post-intervention, and 3-months post-intervention. We will pursue the 
following specific aims. 
1.1 Primary Aims and Hypotheses
1.1.a. Determine the feasibility and acceptability of a home-based lifestyle activity intervention by 
assessing recruitment, retention, adherence rates, and participant satisfaction, and monitoring 
adverse events. We hypothesize that we will meet the accrual target of older cancer survivors 
within 18 months, retain 80% of the sample, and achieve 80% adherence/fidelity to the 
intervention with high satisfaction ratings, while limiting the number of adverse events.
1.1.b. Estimate effect sizes for primary and secondary endpoints for the adoption (baseline to 12 
weeks) and maintenance (3-months post-intervention) of the intervention. We hypothesize that 
compared to the control condition, the intervention will result in improvements in physical 
function (primary outcome) and secondary outcomes: physical performance, objective measures 
of sedentary- and light-intensity activities, and self-reported quality of life. Further, we 
hypothesize that the arm differences at 12 weeks will be sustained at 3-months post-intervention. 
1.2. Secondary Aim 
1.2.a. Conduct a process evaluation using mailed surveys and intervention fidelity assessments to 
inform a larger definitive trial, and more broad dissemination and implementation.
2.0
Background
The unprecedented growth of the U.S. older adult population (≥65 years), the cancer burden in this 
age group (≥50% of diagnoses) and the high survival rate (≥80%),1 is resulting in a rapidly 
expanding high-need population. Compared to the general population, older cancer survivors are 
at higher risk for physical function decline and other comorbidities (e.g., cardiovascular disease, 
osteoporosis), which further exacerbate the risk for functional limitations.2-5 Given the adverse 
consequences of functional impairment, including mobility limitations, increased number of falls, 
hospital/ nursing home admissions, diminished quality of life, premature death, and substantial 
financial costs,6-9 the importance of implementing strategies to delay or mitigate these effects is 
crucial. Despite being the majority of cancer survivors, few health behavior change interventions 
are conducted in older survivors with comorbidities.10 
Regular physical activity has been shown to reduce the risk of these comorbid conditions,11 yet 
<30% of cancer survivors meet the recommended goal (≥150 minutes/week of moderate-to-
vigorous physical activity [MVPA]; e.g., fast walking, aerobics).12-14 Compounding the effects of 

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physical inactivity are the adverse physiologic distinct effects of sedentary behavior [SB].15,16 SB 
is defined as prolonged sitting or reclining with minimal energy expenditure.17,18 SB is associated 
with increased risk of cardiovascular disease,19-22 premature mortality,23,24 and decreased physical 
function,25,26 even among individuals who meet recommended activity guidelines. 
To date, the predominant focus in physical activity research (including in cancer survivors) has 
been MVPA, since this intensity level has been found to confer the greatest health benefits.11 
However, older cancer survivors with physical functional impairment may have different needs, 
preferences, and barriers to being physically active, and thus require a different approach. Light-
intensity activities ([LPA]; e.g., leisurely walking, gardening) are associated with better physical 
health,27 including physical function28,29 and cardio-metabolic biomarkers,30-34 and better 
emotional well-being,27,35 independent of MVPA. Changing the focus from MVPA to LPA 
represents a more achievable and sustainable target for vulnerable populations such as older 
survivors with comorbidities. Despite emerging evidence of the health benefits of LPA, few 
rigorously designed RCTs have been conducted to evaluate the effects of LPA on physical and 
psychosocial health and well-being. 
The majority of physical activity studies have been clinic- or center-based, focused on common 
cancers (breast, prostate, & colorectal), and targeted behavior.36,37 Few studies have focused on 
adults over 65 years or minority survivor populations (race-ethnic minorities, rural), and targeted 
outcomes meaningful to survivors (e.g., patient-reported outcomes).36 Thus, there is a critical need 
for lifestyle activity interventions that are effective, low-cost, and accessible to older cancer 
survivors from diverse backgrounds, designed to be feasible, relevant, and meaningful for them. 
A home-based approach (both intervention delivery and outcomes assessment), expands the reach 
to underserved and underrepresented minority survivor populations.
We propose a home-based intervention focused on increasing light-intensity activity and reducing 
sedentary behavior throughout the day – more obtainable goals – for maintaining and improving 
physical function in vulnerable populations. By reducing barriers to participation, a home-based 
approach will expand the reach to underserved cancer survivors who are older or from rural areas. 
3.0
Inclusion and Exclusion Criteria
The eligibility criteria for the pilot study will vary slightly depending on the recruitment method 
(NMTR vs. self-referrals). The criteria for recruitment via the NMTR are based on increasing the 
likelihood of identifying and contacting cancer survivors who are still alive, healthy enough to 
participate in the study (vs. later stage disease), and for whom the contact information may still be 
accurate. Additionally, there is a 2-year lag in the completeness of data collected and managed by 
the registry. Several of these criteria are not necessary for recruiting through the general 
population, i.e., self-referrals who respond to study posted flyers. As this is a feasibility study, 
some of the eligibility criteria will be relaxed in order to assess our primary aims: the feasibility, 
acceptability, and safety of the intervention.
Identification of potential participants for this study will occur primarily through the New Mexico 
Tumor Registry (NMTR), which is one of the original Surveillance Epidemiology and End Results 
(SEER) Program registries. The NMTR will identify cases diagnosed in NM at age ≥60 years 
within the past 5 years with a local or regionally staged cancer common in older adults (Table 1). 
Random quota sampling based on ethnicity (Hispanic [H] vs. non-Hispanic [NH]) and geography 

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(rural vs. urban) will be employed to ensure equal numbers of subgroups. The sample frame 
includes the entire state of NM. Rural status is defined using codes 4-10 of the RUCA classification 
system (urban = codes 1-3; see NM Map, Figure 1).38-40  
Table 1. Local and regionally staged cancer types common in older adults 
and associated with a 60% or greater 5-year survival rate
Cancer Site
Diagnosis 
Stage(s)
Percentage 
of cases by 
stage
5-year 
relative 
survival 
rate (%)
Median age 
at diagnosis
Bladder
In situ
Localized
51.0
34.0
96.0
69.6
73
Breast (female)
Localized
Regional
64.0
29.0
99.1
86.1
63
Colon & rectum
(excluding carcinoid 
tumors)
Localized
Regional
37.0
36.0
90.9
72.8
66
Endometrial 
Localized
Regional
67.0
20.0
94.9
69.8
63
Gastric (Stomach)
Localized
28.0
71.8
68
Kidney & renal pelvis
Localized
Regional
66.0
16.0
93.0
72.3
65
Larynx
Localized
52.0
78.3
65
Leukemia
-
-
65.7
67
Melanoma of the skin
Localized
Regional
82.0
9.0
99.5
70.6
65
Non-Hodgkin Lymphoma
Stage I
Stage II 
Stage III
Stage IV
23.0
15.0
18.0
35.0
86.5
78.1
72.3
63.9
67
Oral cavity 
(Pharynx & Larynx)
Localized
Regional
28.0
50.0
86.3
69.0
64
Ovary
Localized
Regional
17.0
21.0
93.1
74.2
63
Prostate
Localized
Regional
73.0
14.0
100
100
67

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3.1
Screening.
Initial screening will take place through the New Mexico Tumor Registry. Only key research 
staff will be able to link the name of the cancer patient/survivor with the code number (please 
refer to HRPO#: 85-001). Men and women who meet the following criteria will be identified:

Diagnosed with one of the combinations of cancer-site and stage associated with a 60% 
or greater 5-year relative survival rate and common among seniors (See Table 1 for 
cancer types).

Diagnosed within the past 5 years. This time frame was selected to increase the 
probability of obtaining accurate/current contact information for the patients. Because 
there is a 2 year lag in the completeness of data collected and managed by the registry, 
this increases the probability that the patient has completed primary cancer therapy.

Age 60 years or older at the time of diagnosis (age 65 or older at the time of study 
enrollment); Selection of cancer cases from the NMTR will be based on year of diagnosis 
and age at diagnosis

Known to be alive at the last ascertainment of vital status 

Per NMTR policy, a letter is sent to the cancer survivor from the NMTR to allow him/her 
an opportunity to refuse contact by the study research team.

Current address within the state of New Mexico. Rural cancer survivors will be over 
sampled, such that 50% of the letters introducing the study will be mailed to cancer 
survivors with a rural census tract. Rural status is defined using codes 4-10 of the RUCA 
classification system (urban = codes 1-3; see NM Map, Figure 1).38-40  

Hispanic cancer survivors will be over sampled, such that 50% of the letters introducing 
the study will be mailed to Hispanic cancer survivors and 50% to non-Hispanic cancer 
survivors. Determination of ethnicity will be based on what is recorded in the tumor 
registry and according to an algorithm for Hispanic surnames, per standard procedures 
in place at the NMTR.

Given the scope of the K07 career development award, it is not feasible to seek tribal 
approval for contacting American Indian/Native American cancer patients who are 
included in the NMTR. Therefore, per standard NMTR policies and procedures when 
tribal IRB approval has not been obtained, American Indian and Native American cancer 
survivors will not be contacted by the NMTR on behalf of the study.
Figure 1. NM map of rural 
(light) vs. urban (dark) 
census tracts

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The second screening will take place by telephone approximately 5-8 days after the cancer 
survivor has received the letter from the study that further explains the intervention and 
invites participation. The study coordinator/recruiter will provide additional information 
about the study, answer questions, and assess eligibility.
3.2
Men and women 65 years (at time of study enrollment) and older who meet the following 
criteria are eligible:

Diagnosed in NM within the past 5 years with a loco-regionally staged cancer, completed 
primary treatment (surgery, radiation, chemotherapy), and not currently being treated for 
a recurrence. Individuals on hormone therapy only are eligible. (See Table 1 for cancer 
types) 

Mild-to-moderate physical functional impairment (raw score between 15 and 29 on the 
8-item PROMIS Physical Function survey); representing individuals most at risk for 
functional decline and most likely to benefit from a home-based lifestyle activity 
intervention based on our previous research. (A score of 15 represents 0.5 standard 
deviation [SD] below the population mean; a score of 29 represents 1.5 SD below the 
population mean)

Able to speak, read, & understand English or Spanish. 

Participating in less than 120 minutes per week of MVPA (otherwise a program to 
increase MVPA would be more suitable)(determined using Godin Leisure Time Exercise 
Questionnaire – low respondent burden). 

Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 
mile) without an assistive device (e.g., cane, walker) and without stopping to rest. 

No severe impairments (in seeing or hearing) or pre-existing medical limitations for 
engaging in daily LPA (e.g., severe orthopedic conditions, pending hip/knee 
replacement, dementia, oxygen dependent, chronic vertigo).

No paid employment or volunteer position for greater than 20 hours per week (to avoid 
potential confounding by occupation activity/inactivity)

Not currently participating in a program (personal, e.g., wearing an activity monitor, or 
structured, e.g., another study) to decrease sedentary time or increase physical activity.

Not planning to move out of New Mexico within the next year.

Own a smartphone, tablet or computer OR be willing to use a study provided smartphone 
capable of running the Fitbit app or website. Additionally, access to the internet or a Wi-
Fi hotspot at least once per week is required. Smartphones and data plans will be provided 
to those individuals who are eligible but do not currently own a computer, tablet or 
smartphone. Participants loaned a study phone will be asked to sign form indicating they 
agree to return the phone at the end of the study.

Availability of a family member or friend to be present (for safety) during remote 
assessment of physical performance tests.

Willingness to be randomized to either study arm and to wear activity trackers 
(activPAL3 [sedentary behavior, standing, stepping] at weeks 1, 13, and 26 for 7 days; 
the Fitbit activity tracker during weeks 2-26 during waking hours if randomized to the 
immediate intervention arm; during weeks 14-26 if randomized to the delayed 
intervention arm).

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3.3  Exclusion Criteria 

Adults not able to consent are excluded from participation 

Based on the age criteria (65 years and older), individuals who are not yet adults (infants, 
children, teenagers) may not participate in this study due to the same age criteria above 

Pregnant women may not participate in this study due to the same age criteria above 

Prisoners may not participate in this study as this is a study of free-living individuals
3.4
Self-referrals and Community-based recruitment
Recruitment through the NMTR is our primary recruitment method. However, we will also 
screen for eligibility, those individuals who self-refer to the study. We will provide study 
flyers to various community-based organizations, e.g., cancer support groups; community 
centers; senior centers; clinics; etc. Additionally, oncologists or physicians may refer their 
patients (cancer survivors) to the study by giving them a study flyer.
We will also contact participants of completed studies who provided permission to 
recontact about new studies being conducted by the PI at UNM.
Note: Given the nature of this pilot study (to assess feasibility and acceptability of the 
intervention among older cancer survivors), the eligibility criteria are less restrictive for 
self-referred participants. 
Modifications to the above eligibility criteria for self-referrals include the following:

Any cancer type and stage, as long as the patient has completed primary cancer 
therapy (surgery, radiation, chemotherapy) and it has been at least six months 
since diagnosis. Metastatic cancer patients are eligible with MD written or 
verbal approval. 

Cancer diagnosis greater than 5 years ago will be eligible.

Must live in NM, but could have been diagnosed with cancer outside of NM. 
Eligibility is dependent on confirmation of cancer diagnosis (via NMTR or 
physician).
4.0
Study-Wide Number of Subjects
This study will enroll up to 70 cancer survivors. If individuals are determined to be ineligible or 
withdraw after consent, but prior to randomization, we will replace them with another eligible and 
interested individual. The goal is to randomize 64 participants. In order to achieve this accrual 
target, we estimate that the NMTR may need to contact 600 or more cancer patients identified in 
the registry due to the number of eligibility criteria and a conservative estimate of 20% 
participation rate.
5.0
Study-Wide Recruitment Methods
NA - This is not a multi-site study.

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6.0
Multi-Site Research
NA - This is a single-site study.
7.0
Study Timeline
The table below outlines the proposed intervention trial, which is 12 weeks in duration with 
(telephone, email, and mail) contact by study staff followed by a 3-month maintenance period 
(limited contact with study staff). The trial begins with the baseline assessment (week 1) and ends 
with a 3-month post-intervention follow-up assessment (week 26). Recruitment will take place 
over a period of 15 months.  This trial is individual-based vs. group-based, so the intervention for 
a subject begins once the subject has provided written informed consent and completed the 
baseline assessment.  This is a 2-year study. 
Study Timeline
2023
2024
2025
Quarter: 
3
4
1
2
3
4
1
2
Recruitment
Intervention Delivery
Ongoing data entry/cleaning
Analyses/manuscript prep
Prepare and submit R01
8.0
Study Endpoints
Primary endpoints include: a) process data (enrollment, retention and adherence rates; satisfaction 
with the program), and b) change in self-reported physical function.
Secondary endpoints include change in: a) subjective and objective measures of sedentary- and 
light-intensity activities, b) physical performance, and c) self-reported quality of life (QOL).
Safety endpoints: 
All adverse events associated with the physical performance tests (see section 9.0) will be tracked. 
The performance tests incorporate movements typically undertaken during normal daily activities 
(standing from a chair, sitting on a chair), and thus represent tests that are more likely to be safely 
performed in the home. A friend or family member will be present during the remote assessment 
of physical performance, which is conducted in the study participants’ homes. Safety checks will 
be made prior to the performance tests (see section 13.0 Potential Risks to Subjects / Protection 
Against Risks).
Additionally, study participants will be encouraged to report any “emergencies or events” by 
calling the toll-free study number. See Data Safety and Monitoring Plan for more details.

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9.0
Procedures Involved
Study Design
Baseline Assessment, Randomization: Interested and eligible individuals will be mailed a packet 
for the baseline assessment. The packet includes one activity monitor (for objective measurement 
of light-intensity physical activity [LPA] and sedentary behavior [SB]), instructions for use (video 
and print), and questionnaires (see Table 2). Participants will be instructed to wear the 
ActivPAL3TM monitor41 during waking hours for one week, consistent with other studies.42-44 
Participants will be asked to complete a sleep and activity monitor log so during data analyses, 
sleep time can be distinguished from sedentary time. At the end of the week, participants will 
complete questionnaires on both SB and physical activity to provide context to the objective data. 
Instructions will be provided for returning (via self-addressed stamped mailer) the monitors and 
questionnaires to study staff. Upon receipt, participants will be block randomized with equal 
allocation to 2 arms (intervention vs. waitlist control) within four strata defined by self-reported 
ethnicity (Hispanic vs. non-Hispanic) and geographic location (urban vs. rural, see Fig. 1).
Remote assessment of physical performance:  Based on our findings from the Remote 
Assessment of Physical Function Study (17-334), participants would prefer to use their own device 
(smartphone, tablet) to videoconference with the study investigators. Additionally, we learned 
from this study that the Time Up & Go performance test is not very accurate, given the lag/stutter 
of the audio and/or video. Participants’ smart phone or tablet will be used to conduct the remote 
assessment of the physical performance tests self-administered by study participants in their own 
home. If a participant does not have a suitable device, the study will provide a smartphone to 
capture the physical performance tests. Instructions will be provided that demonstrate the 
performance tests and safety measures. Further instructions will be provided by the investigator 
via videoconferencing. The investigator will perform the assessment from a remote location (i.e., 
UNM) using videoconferencing software (Zoom or Skype). During the videoconference, the 
investigator will review the instructions for the tests, and will signal the start and stop time of the 
tests (the tests are timed using a standard stopwatch). A separate software (Snagit) run on a study 
computer will be used to record the assessments for later viewing and scoring (i.e., timing via 
stopwatch) for quality control purposes.
The physical performance tests include the 30-second chair stand test and the 4-stage balance test 
(see Table 2). These tests incorporate movements typically undertaken during normal daily 
activities, and thus represent tests that are more likely to be safely performed in the home, under 
supervision of a family member or friend (and remote supervision by the study investigator). 
Both tests are timed. The first test is the 4-stage balance test and includes four different positions, 
which the participant will be asked to hold for 10 seconds. The participant may decline to try any 
of the positions if they feel it is unsafe. Also, if the participant is unable to maintain their balance 
for 10 seconds, they do not proceed to the next position. The four positions include: feet side-by-
side, semi-tandem (one foot slightly behind the other), full-tandem (one foot directly behind the 
other), standing on one foot; For the 30-second chair stand test, the participant will stand up from 
a chair without using their arms and sit back down again, and to repeat this for 30 seconds. The 
participant is instructed to perform the test quickly, but safely, and can slow down or stop before 
the end of the test. A friend or family member much be present for this portion of the study. 

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These video calls will be recorded for quality control.  These video recordings will be destroyed 
3 years after the study closes. The participant is provided with both written and video 
instructions of how to perform these tests safely, and how to prepare for the videoconference 
session with the study investigator. 
 Lifestyle Activity Intervention: The goal of the 
intervention is to be more active throughout the day, every 
day – a whole-of-day approach - without regard for 
frequency, intensity, or duration of activity bouts. To 
promote gradual and sustained change, participants will be 
asked to increase the number of steps per day (above their 
individual baseline level) during weeks 3-12, and then work 
to maintain their goals during weeks 13-25 (Table 3). The 
target of 3,000 extra steps per day represents approx. 30 
extra minutes of LPA,45 which is associated with health 
benefits.27,46 To encourage activity throughout the day (and 
reduce SB), participants will work towards 10 of 14 active 
hours per day (defined as >250 steps/hour in Fitbit). 
Frequent interruption of sitting is associated with better 
cardiometabolic health.21,47-49 In accordance with SDT and 
MI, participants will choose their own strategies for 
becoming more active and achieving their weekly goals 
with guidance and (technology) support from their health 
coach. A menu of ideas will be provided in their education materials, but participants will be 
encouraged to identify options that work best for their lifestyle. 
 
Fitbit Inspire 3 TM wearable activity tracker: During week 2, participants in the intervention 
group will be mailed the Fitbit Inspire 3TM activity tracker, and detailed instructions for installing 
the app on their smartphone or tablet and for using the tracker with the app. The distinguishing 
feature is an activity reminder in which the tracker gently vibrates if fewer than 250 steps were 
taken in the previous 50 minutes, and a suggestion to take more steps in the next 10 minutes (to 
achieve goal of ≥250 steps/hour). Data from the tracker is wirelessly synced to the app. Participants 
will be instructed to wear the tracker during waking hours and will be encouraged to track their 
activity via their app/website at least once a day, which includes a daily summary of total steps 
and number of active hours (hours with ≥250 steps). The health coach will assist with the 
installation, review instructions for using the tracker and app, set goals (steps per day, # active 
hours), and track their progress. If needed, a family member or close friend will be included on 
telephone calls to assist the study participant.
A Fitbit account is required as part of installing the free Fitbit app. To create the Fitbit account, 
the study team will use a de-identified placeholder for the participant’s first and last names, and 
the first day and month of their true birth year. For more accurate step tracking, the participant’s 
sex, and their self-reported height and weight will be added to the account. The study team will 
create and assign an email address for the sole purpose of creating each Fitbit account. The study 
team will manually connect the Fitbit account to the study’s Fitabase account. 
Table 3.  Intervention Schedule
Wee
k
# Active
Hours/ 
day
Steps/d
ay 
(above 
baselin
e)
Minimu
m 
# 
days / 
week
1
Baseline assessment 
randomization, Fitbit mailed to 
participant
2
Establish Fitbit baseline data
3-4
6
1000
3,5
5-6
7
1500
3,5
8-8
8
2000
3,5
9-10
9
2500
3,5
11-
12
10
3000
3,5
13
Post-intervention assessment
14-
25
Maintain goals (no study 
contact)
26
3-months post-intervention 
assess.

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Fitabase (Small Steps Labs LLC): https://fitabase.com/ Fitabase is a research platform that collects 
data from internet connected consumer wearable activity trackers. For this study, data will be 
collected from each Fitbit activity tracker by Fitabase. The data to be collected includes
Total daily steps, number of steps per minutes, estimated energy expenditure, distance 
moved, minutes of vigorous, moderate, and light activity, minutes of sedentary time, sleep 
length and quality (if Fitbit worn overnight), heart rate, and manually entered and 
automatically detected physical activities such as walking or running.
Once the study team connects a Fitbit account to Fitabase, Fitabase collects all new data that is 
collected by the device.  When the device syncs (i.e., transfers data), Fitabase is notified of data 
availability, requests the new data, and then processes the data in order to make it available to the 
study. The study team will download study participant’s de-identified data from Fitabase. Fitabase 
does not collect personally identifiable data. Each study participant is de-identified with a 
participant ID. Fitabase does not receive the associated email address, the Fitbit account name, 
Fitbit Friends list, or any GPS data. 
Participants will be given Fitabase’s Terms of Use and the Privacy Policy upon request. By 
consenting to use the Fitbit device as part of this study, the participant also consents to the Fitabase 
Terms of Use and Privacy Policy. At the end of the study, the participant gets to keep the Fitbit 
device and will receive instructions how to change the email address associated with the Fitbit 
account, At the end of the study or if a participant withdraws from the study we will disassociate 
the Fitbit account from the Fitabase account. 
Health Coach Calls / MI:  Research assistants will undergo MI training specific to this study. MI 
techniques and micro-skills will be used to guide five sessions of telephone-based health coaching, 
which will occur during weeks 3, 5, 7, 9, and 11. Key intervention topics and techniques include: 
establishing rapport; eliciting knowledge about adverse effects of inactivity/SB and benefits to 
becoming more active; assessing motivation, confidence, perceived importance and barriers to 
becoming more active; eliciting change talk; and enhancing participants’ self-efficacy 
(competence) and motivation to be more active (e.g., small, achievable goals). The health coach 
also provides tech support to the participant for assessments (activPAL and performance testing) 
and using Fitbit with their mobile app (weeks 1, 2, 13, & 26). The first call (week 2) to help the 
participant set up their Fitbit may take up to 45 minutes, but can be much shorter depending on the 
participant’s comfort level with technology. The first health coaching call may take up to 45 
minutes (week 3); the remaining four health coaching calls will take 20 minutes each (weeks 5, 7, 
9 and 11). Health coaching calls will be audio recorded and reviewed for quality control. Audio 
files will be destroyed 3 years after the study closes.
Educational Materials: Participants will be mailed educational materials (visual aids) to be used 
during the telephone calls with their Health Coach. The handouts include: (a) the benefits of LPA 
and suggestions for how to add more steps to their day, throughout the day (i.e., breaking up 
sedentary time through at least minimal stepping each hour); (b) reasons to be physically active; 
(c) example plans for meeting step goals; (d) ideas for getting more steps; and (e) pages for the 
participant to write their plan for each week. Instructions for setting up and using the Fitbit Inspire 
3 tracker and mobile app will be included. All materials serve as reference for discussions with the 
health coach. 

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Intervention Fidelity: We will use evidence-based MI training procedures identified in previous 
studies.50,51 The health coaches will receive an initial 1.5 days of in-person MI training by Dr. 
Walters (consultant, clinical psychologist). Prior to contacting participants, the coaches will 
complete 4 practice sessions, and receive feedback via 4 phone supervision sessions. Dr. Walters 
will code the sessions for MI fidelity by using the MI Treatment Integrity Coding System, version 
4.1,52 and use this information during supervision sessions. During the study period (15 months), 
the health coaches will submit one audio recording and participate in one phone supervision per 
week (months 1-2), then per month (months 3-15). An intervention fidelity checklist will be 
created to assess the other intervention components, i.e., promoting and supporting self-efficacy, 
knowledge and skills, self-monitoring, autonomous motivation, and social support to become more 
active. With HSC Affiliate status, Dr. Walters will review the selected audio files saved to the 
secured P drive. 
A Waitlist Control was selected to help boost recruitment and retention. Participants will be asked 
to maintain their usual lifestyle during the 12-week intervention. After the 12-week waitlist period, 
participants will receive (via mail) a Fitbit Inspire 3TM monitor and education materials, and the 
full telephone-based MI intervention with the health coach.
Retention: To enhance recruitment, retention, and adherence rates and to compensate participants 
for their time and offset phone data charges, a $50 merchandise card will be provided for each 
outcome assessment ($150 total). Additionally, both groups will be able to keep the Fitbit activity 
tracker after the study ends.
Follow-up assessment: The ActivPAL3TM monitor, and instructions will be mailed to all 
participants to collect 1-week of data for secondary outcomes during week 13. The packet will 
also include questionnaires to assess subjective outcomes (see Table 2). The RA will call to review 
the instructions and answer any questions. The same procedure will be used for the 3-month post-
intervention follow-up assessment.
Participant Advisory Board (PAB): The PAB will include 4-5 cancer survivors from the 
community. The PAB will meet twice per year (years 2-5) with the study team to provide advice 
and guidance on the protocol and study materials for both the validation study and RCT, 
interpretation of the study/RCT results, and identify next steps and strategies for the future, larger 
RCT (R01 application).
Study Flow:  The table below describes the flow of the study from recruitment through 
intervention delivery to assessment of outcomes. Form of contact (phone, email, or mail) is 
indicated. Important information is conveyed over the phone (e.g., eligibility assessment, 
consent) and the use of email is dependent on participant preference for minor communication 
(e.g, reminders).
Phone
Email
Mail
Fees/
Postage
IN
OUT
IN
OUT
IN
OUT
$
X
NMTR-> mail letter about study & flyer
(X)
(X)
(X)
(Possible reply by potential ppts)

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Phone
Email
Mail
Fees/
Postage
IN
OUT
IN
OUT
IN
OUT
NMTR releases contact info to Study Team
$
X
Mail letter of invitation, flyer, & consent form
X
X
X
Recruitment materials to community settings
(X)
(X)
(X)
Possible reply by potential ppts
X
Investigator determines interest & eligibility 
using
REDCap recruitment screener

If refusal  Refusal Qs

If interested & eligible  Go to ppt info
X
Schedule time to review consent w/ ppt
$
(X)
(X)
Mail or email consent form (if lost copy)
X
Review consent
$
X
X
Ppt mails signed consent form or e-signs 
X
Mail ppt photocopy of signed consent form 1
X
Once received, investigator contacts ppt to 
schedule BASELINE assessment, preference 
for surveys 2  (see Assessment Call 1 Script 
…)
Verify receipt of packet and schedule remote 
assessment w/ Tawny via MYHealth calendar 
(see Assessment Call 2 Script …)
$
(X)
X
Survey packet & cover letter mailed to ppt 
(optional: email w/ REDCap link)
X
X
Reminder to ppt about assessment (need 
another person present for physical function 
tests) (see Assessment Call 3 Script …)
X
Reminder to ppt about assessment (text from 
Tawny with link to Zoom or Skype 
videoconference session for physical function 
tests)
X
Remote assessment conducted / completed 
via Skype or Zoom
X
X
Follow-up for incomplete surveys; return of 
activPAL (see Assessment Call 4 Script …)
$
X
Randomization and mail gift card:

Group A: mail thank you (on card 
stock) and gift card; start intervention; 
mail cover letter, Fitbit, Fitbit 
instructions, & MI Visual Aids (1st 2 
Health Coaching calls)

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Phone
Email
Mail
Fees/
Postage
IN
OUT
IN
OUT
IN
OUT

Group B: mail thank you letter 
(maintain usual activity for 12 weeks; 
then receive full intervention) and gift 
card.
X
Fitbit setup; verify receipt, ask if ppt would like 
help; reminder: maintain usual activity for 1 
week; schedule 1st health coaching call
X
1st Health Coaching Call; review Fitabase 
before call; record notes on MI Visual Aids;
X
2nd  Health Coaching Call; review Fitabase 
before call; record notes on MI Visual Aids;
$
X
Mail MI Visual Aids (calls 3-5)
X
3rd Health Coaching Call; review Fitabase 
before call; record notes on MI Visual Aids;
X
4th Health Coaching Call; review Fitabase 
before call; record notes on MI Visual Aids;
X
5th Health Coaching Call; review Fitabase 
before call; record notes on MI Visual Aids;
Schedule 13-week Assessment

Schedule remote assessment w/ 
Tawny via MYHealth calendar

Ask survey preference (mail/online)

(see Assessment Call 1 Script …)
X
Waitlist Control Group – 13-week 
Assessment:

Schedule remote assessment w/ 
Tawny via MYHealth calendar

Ask survey preference (mail/online)

Inform ppt Fitbit will be mailed

(see Assessment Call 1 Script …)
(X)
X
Survey packet & cover letter mailed to ppt 
(optional: email w/ REDCap link)
Verify receipt of packet (see Assessment Call 
2 Script …)
X
X
Reminder to ppt about assessment (need 
another person present for physical function 
tests) (see Assessment Call 3 Script …)
X
Reminder to ppt about assessment (text from 
Tawny with link to Zoom or Skype 
videoconference session for physical function 
tests)
Remote assessment conducted / completed 
via Skype or Zoom

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Phone
Email
Mail
Fees/
Postage
IN
OUT
IN
OUT
IN
OUT
X
Follow-up for incomplete surveys; return of 
activPAL (see Assessment Call 4 Script …)
X
Mail gift card (after verifying activPAL 
returned, and remote assessment AND 
surveys completed)
X
Mail letter to immediate intervention group 
(maintain usual activity; next study contact in 
12 weeks)
Start intervention for waitlist control 
participants (Fitbit setup, 5 health coaching 
calls)
26-week assessment

Schedule remote assessment w/ 
Tawny via MYHealth calendar

Ask survey preference (mail/online)
Repeat steps from 13-week assessment
Post-study telephone survey
NOTES:
1 Whoever conducts the consent process signs the participants’ form once received; for e-
consent; print consent form, sign, photocopy and keep one copy in the ppt’s folder; mail a copy 
of signed consent to ppt
2 Whoever conducts the consent process signs the participants’ form once received; for 
e-consent; print consent form, sign, photocopy and keep one copy in the ppt’s folder, 
mail a copy to ppt

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Outcomes and Measurements
All measures have well-established validity and reliability, and are responsive to change.
Table 2.  Outcomes & Measures (B=baseline; P=1-week post-intervention; F=3-months post-intervention 
follow-up to assess maintenance of behavior change & effects)(alpha=Cronbach’s alpha; ICC=intraclass 
correlation test-retest reliability; RMSEA=root mean square error of approximation; CFI: comparative fit index)
B P
F
Process Data   (primary outcomes):  As this is a feasibility and acceptability study, the primary outcomes relate to 
recruitment, retention, adherence, and adverse events, which will be carefully tracked. Collected and used to 
evaluate adherence: steps per day/number of active hours (downloaded from Fitbit® website), satisfaction with the 
program, likes & dislikes, barriers & issues, perceived degree of benefit, and intervention fidelity (see above)
X
X
Physical Function   (primary outcome) / Physical Performance (secondary outcome):  
Subjective Measure: Self-reported physical function, a patient-reported outcome (PRO), is a key measure of physical 
health and well-being in cancer surviviors.
Objective Measures: Two standard gerontology assessment tests will be used to measure physical performance: the 
30 second chair stand test (30s-CST) and the 4-stage balance test. Both of these tests are included in the CDC 
Stopping Elderly Accidents, Deaths, & Injuries (STEADI) toolkit for assessment of falls [43, 44].  
The 30s-CST involves standing up from a chair and sitting down as quickly and safely as possible, preferably 
without the use of upper extremity support [44, 51]. It is measured by the number of times a person comes to a full 
standing position from a chair in 30 seconds. The 30s-CST is a measure of lower extremity strength and dynamic 
balance, and has good validity [0.7<r<0.8] and excellent reliability [ICC=0.84-0.92][51].
The 4-stage balance test includes standing in each of four positions for 10 seconds: 1) feet side-by-side; 2) semi-
tandem stand [one foot slightly behind but touching the other foot]; 3) tandem stand [one foot in front of the other; 
heal touching toe]; and 4) stand on one foot. 
X
X
X
X
X
X
Physical Activity and Sedentary Activity  (secondary outcomes) 
Subjective Measures:  (1) Godin leisure-time activity questionnaire will be used to screen for eligibility and to provide 
context for activities that changed in frequency, intensity, and duration during the intervention as objectively 
measured by activPAL. Godin’s is a short survey with low respondent burden.53
(2) The PACE Adult Sedentary Behavior Questionnaire will be used to estimate self-reported sedentary activities 
during a typical weekday and during a typical weekend. Response items range from none to 6 or more hours per day 
for nine common activities (e.g., watching television, using a computer, reading, etc.)54. Self-reported SB will provide 
context for SB measured objectively by ActivPAL3TM monitor. 
Note: 
Objective Measures: Daily LPA, MVPA, and SB will be objectively measured before and after the intervention using 
the activPAL3 monitor55. The ActivPAL3, worn on the thigh,41 includes both a triaxial accelerometer and an 
inclinometer (to detect change in posture, i.e., sitting vs. upright posture) and is the gold standard in SB research.27,56-
59 
Operational definitions:56  (a) Total LPA & MVPA: sum of stepping bouts with a step rate of <100 and ≥100 
steps per minute, respectively for activPAL. (b) Total SB: sum of all sitting/lying bouts. (c) Total steps per day. 
(d) Total waking hours with ≥250 steps.60,61
Note: FitbitTM and mobile app are used by study participants to monitor their (in)activity in real-time & prompt behavior 
change. The data (steps per day, hours/day with >250 steps) downloaded from the Fitbit website will only be used 
to assess adherence to the intervention; not to evaluate the secondary outcome.
X
X
X
X
X
X
Quality of Life   (secondary outcome):  
QOL will be measured using PROMIS (Patient-Reported Outcomes Measurement Information System) measures 62. 
The 8-item short forms are used to assess domains in mental health (anxiety and depression), physical health 
(physical function, fatigue, pain, sleep disturbance, and sleep impairment) and social health (satisfaction with social 
roles and activities, i.e., social functioning). These instruments are valid and reliable for use in diverse clinical 
samples 
63-66. 
Surveys 
will 
be 
scored 
using 
the 
free 
HealthMeasures 
Scoring 
Service 
(https://www.assessmentcenter.net/ac_scoringservice). The service provides T-scores, which represent a linear 
transformation of the raw scores, normed to the general population, with a mean of 50 and a standard deviation of 
10.
X
X
X

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Sociodemographics, Health-Related Characteristics, and Medical History   (other)  
Used to characterize study population and/or as predictors of adherence or moderators of intervention effects
Sociodemographic Data:  age, sex, race/ethnicity, education, income range, marital status (self-report)
Health-related Behaviors: smoking status; height & weight to calculate BMI (kg/m2)(self-report)
Cancer Data: obtained via NMTR (cancer site, stage, age & year of diagnosis, summary treatment) and self-report 
(treatment (yes/no): surgery, chemotherapy, radiation, hormone therapy; year primary therapy completed)
Comorbidities: The Older Americans Resources & Services (OARS) Comorbidity Index will be used to assess the 
number of chronic medical conditions and symptoms and their functional impact 67. The survey includes 42 conditions 
and symptoms (not including cancer), and whether each condition/symptom interferes with activities (not at all, a 
little, a great deal) 67. Number/severity of comorbidities will be evaluated as predictors of adherence, & change in 
primary & sec. outcomes.
Fall risk:  Risk for falls will be assessed by the Falls Efficacy Scale International. The survey includes 16 questions 
that assess how concerned someone is with doing various activities inside and outside their home. 
Tech savviness: To prepare study team members to guide and support study participants through the technological 
aspects of the study (setting up and using Fitbit, videoconferencing), a short survey about the use of and comfort 
level of using their smartphone will be administered by the study team over the telephone.
X
X
X
X
X
X
X
X
X
X
X
X
Theoretical Constructs (potential mediators) 
Self-efficacy:68 domain specific; we will measure confidence for increasing LPA and decreasing SB with 3 items.
Social Support for Physical Activity Survey: 4 items using a 5-point scale to measure support from family and 
friends while making changes to physical activity. 
Multidimensional Outcome Expectations for Exercise Scale: 15 items to assess physical, social, and self-evaluative 
beliefs about consequences of being physically active. (Good internal consistency: alpha=0.76-0.84; and Good 
model fit: RMSEA: ≤0.07; CFI:≥0.92 in older adults)69,70 
Behavioral Regulations in Exercise Questionnaire (BREQ-2): 19 items to assess autonomous motivation on a 
continuum from amotivation to intrinsic motivation. Will be adapted using identical anchors for LPA. (Good internal 
consistency: alpha=0.74-0.91; excellent model fit: RMSEA=0.02; CFI=0.95)71,SP-72
Perceived Autonomy Support – Sport Climate Questionnaire (short form): 6 items to assess autonomy support of the 
health coach to characterize the quality of the social environment for influencing motivation.
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
**NOTE: Additional data will be provided by the NMTR to characterize the non-
responders. NMTR will provide the aggregate status (total count) based on their attempt to 
contact the patient, prior to releasing names to study staff. The status values include:

Released, Patient actively  or passively agreed to participant in this study

Refused, Patient actively refused to participate in this study

Do Not Contact, patient is eligible to participate but does not want to be contacted 
for any studies

Bad Address, unable to contact the patient because the letter was undeliverable

Ineligible, the patient was ineligible to participate in this study because of age, date 
of diagnosis, site, etc.  This could happen if the patient notifies the NMTR of a 
discrepancy in their data.   I.e. Date of birth is wrong or different diagnosis.

Deceased, patient died prior to our attempt to contact them or prior to releasing the 
data to the study.
Additionally, for those patients referred to the study, additional aggregate data (means and 
standard deviations or total count) will be provided for non-responders (separately by 3 
groups: ineligibles, passive refusal, active refusal): cancer site, stage of diagnosis, age and 
year of diagnosis, and summary treatment.

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This intervention trial includes a 3 month follow-up assessment to evaluate whether the behavior 
change has been maintained (light-intensity physical activity, reduced sedentary activity), and 
whether the patient-reported outcomes have changed (e.g., quality of life, physical function and 
physical performance).
10.0 Data and Specimen Management
Data Management
Each participant will be assigned a unique number to identify their data. This unique number will 
be placed on each document (questionnaires) and included in each electronic file name 
(accelerometer data files created by software used to download the data) to identify the 
participant. 
Data from questionnaires will be entered into a REDCap database. Only essential study personnel 
will have access to this database. Data entry will be tied to the unique number assigned to the 
study participant.
Data from the activPAL accelerometers will be downloaded using the PAL Technologies software 
packages and stored on a secure data server at UNM. The files will be identified by unique study 
ID number and assessment (baseline, post-intervention, or 3-month follow-up).
A data collection form will be used by the study personnel conducting the remote assessment of 
physical performance. This form will be identified using the unique study ID number. Data from 
this form will be entered into the REDCap database.
All paper files, including consent forms, will be stored in locked drawers. All electronic files, 
including audio recordings and video recordings will be stored on a secure data sever at UNM. 
All electronic files will be destroyed 3 years after the study closes. .
Recorded audio files with the Health Coaches will be saved on a secure server at UNM and 
saved with the unique Study ID number.
Recorded videos of remote physical performance tests will be saved on a secure server at UNM 
and saved with the unique study ID number.
Statistical Analyses
Overview: Outcome variables violating the normality assumption will be transformed prior to 
analyses. The pattern of missing data will be evaluated,73 and the appropriate procedures for 
multiple imputation will be utilized. Primary analyses will be performed according to the intent-
to-treat principal; as this is a feasibility study, per-protocol analyses also will be explored. 
ActivPAL3TM data will be downloaded using associated software, and analyzed using SAS and R 
software. Raw and event data (start/stop time for sitting/lying, standing, and stepping) will be 
processed using standard methods, e.g., determining valid wear time,74-76 threshold values for 
activity intensity,27,77,78 etc. Standard compliance criteria will be used (≥4 days with ≥10 
hours/day).27,79 Quality controls (daily logs, visual examination of heat maps) will be used to check 

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classification of accelerometer data. Accelerometer methods will be published according to 
guidelines.80-82
Aim 1 - Feasibility & Acceptability: For this feasibility study, we hypothesize that we will meet 
the accrual target of 64 inactive, older cancer survivors within 18 months, retain 80% of the 
sample, and to achieve 80% adherence/fidelity to the intervention. No formal statistical analyses 
are needed for these hypotheses.
Aim 2 - Preliminary estimates of effect sizes: We hypothesize that physical function scores will 
improve in the intervention group compared to the control group. We will obtain means and 
precision estimates for between-arm differences in physical function scores at each time point. A 
linear mixed-effects model will be used with group, time, and group by time interaction, adjusted 
for ethnicity, rural/urban status, and baseline values as needed. The appropriate variance-
covariance structure will be selected to account for the potential correlation among repeated 
measurements from the same participant. The primary test of interest is the group by time 
interaction, indicating whether there was a difference between groups in the primary outcome over 
time. Similar analyses will be conducted for secondary outcomes. 
Aim 3 - Process evaluation: will be conducted via a mailed survey. Process data (Table 2) and 
other study related outcomes will be reviewed with the PAB to identify next steps and strategies 
to ensure the most appropriate design and methods for the future, larger RCT, with potential for 
broad dissemination and implementation.

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Power / Sample Size Calculation
Using a 2-sided, 2-sample t-test, with a significance level of 0.05 and 25 people per arm, we will 
have 80% power to detect a mean difference of 8.1 in physical function scores (a large effect size) 
with a standard deviation of 10. To allow for 20% attrition, we plan to enroll and randomize 32 
participants per arm. The results of the feasibility trial will inform the design (sample size, effect 
size) of a larger trial powered to examine efficacy
Maintaining Confidentiality
The following steps will be taken to secure the data and to maintain confidentiality:

Study participants will be assigned a unique study ID.

All data collected will be identified with the unique study ID.

Identifying information (e.g., name, address, etc.) will be kept separate from the 
participant’s study data.

The PI will have access to the electronic “link” between identifying information and the 
study ID (Excel spreadsheet). The link (Excel File) will be password protected and kept on 
a secure computer server.

Only trained study staff will have access to the data.

Other data collected during the study will be stored on a password and firewall protected 
server and accessed via secured computers in the Cancer Research Facility. Any paper 
forms, including informed consent forms will be kept in a locked file cabinet of the study 
staff for up to three years.

Study staff are required to have completed training for the responsible conduct of research.

For participants receiving a study purchased smartphone for use during the study, upon 
return to study staff, all data from the phone will be deleted prior to sending to another 
participant for use during the study.

If a smartphone is provided to a study participant to use with either their Fitbit or 
assessment of physical performance, prior to mailing the phone to study participants, any 
identifying information from previous participants’ use will be deleted.

The videoconference sessions (such as Zoom or Skype) will be recorded and the files will 
be stored on a secure computer server. The files will be password protected and the file 
name will not include any identifying information (e.g., study ID number rather than 
participant’s name). These video files will be saved in a limited-access (only key 
personnel) folder on the secure server for up to 3 years upon completion of the intervention 
trial. This time will allow for publication of the study results and to allow the PI to retrieve 
any additional information to inform the remote assessment for the future definitive trial, 
if needed.
11.0 Provisions to Monitor the Data to Ensure the Safety of Subjects
This study does not involve the testing of pharmacologic agents nor any therapeutic treatments. It 
is a behavioral intervention aimed at promoting physical activity using a whole-of-day approach, 
i.e., increasing light-intensity physical activity throughout the day while reducing and disrupting 
sedentary activities. Thus, it is classified as a Type 3 Study (Non-therapeutic, non-physical 
intervention), a minimal risk level study.

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For the physical performance tests, the safety of subjects will be monitored in real-time, i.e., 
during the performance of the brief, timed tests. The study team will not allow the test to start or 
will stop it early if they believe there is a risk of injury to the participant, .e.g., if participant is 
feeling dizzy, is not feeling well, or has recently suffered an injury that could affect the 
participant’s ability to safely perform the tests. 
Study participants will be encouraged to report any “emergencies or events” by calling the toll-
free study number. Study staff will record all reported events in the adverse event log (including 
the subject’s name, date, and event description) and inform the principal investigator, Cindy Blair, 
PhD, immediately of any unanticipated study deaths or serious events that potentially jeopardize 
participation in the study. Dr. Blair will consult with her mentors/Co-Investigators on the action 
that should be taken. This communication will occur within 24 hours (for an unanticipated study 
death), and four business days for an unanticipated serious event. This action and date of 
implementation also will be recorded in the adverse event log. During the quarterly meetings, the 
PI and her mentors will classify any reported events as “serious” or “non-serious” (see 
classification below), as well as “non-attributable”, “possibly attributable” or “attributable” to the 
intervention (unlike a pharmaceutical trial where known side effects exist, the classification of 
“expected” vs. “unexpected” is inappropriate for this behavioral intervention). 
Serious—any event or condition that is life threatening, results in overnight hospitalization, cancer 
or a physical or cardiac event serious enough to require medical attention. A brief listing follows:
Fatal
Life threatening
Permanently disabling
Required or prolonged (overnight) hospitalization (Admission—not ER visit)
Overdose
Significant hazard to patient
12.0 Withdrawal of Subjects
At any time during the study, participants may ask to withdraw from the study. If the investigator 
feels that it is no longer safe for the participant to participate in the study, (i.e., the participant no 
longer meets the study eligibility criteria), the participant will be withdrawn from the study without 
their consent. 
13.0 Potential Risks to Subjects / Protection Against Risks
This trial poses minimal risk, since the intervention specifies only light-intensity physical 
activity (e.g., standing, walking), which the participants are likely to already be doing, and 
thus may just be increasing in frequency or duration. Individuals for whom unsupervised 
light-intensity activity is not appropriate will be excluded from the study per the eligibility 
criteria. Nevertheless, there are some potential risks associated with the objective measure 
of sedentary activity. Sedentary activity will be assessed with a small, light-weight monitor 
(ActivPAL3TM) worn on the thigh, and attached to the skin via an adhesive. If the attachment 

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causes any discomfort or irritation during the one week of data collection, the monitor will 
be moved to a different location if possible. 
The remote assessment of physical performance poses minimal risk, since the two performance 
tests primarily incorporate movements typically undertaken during normal daily activities 
(standing from a chair, sitting on a chair), and thus represent tests that are more likely to be safely 
performed in a home setting. Note that both the 30 second Chair Stand test and the 4-stage balance 
test (see Table 2) have been routinely conducted in adult populations with mild to severe 
functional impairment such as cerebral palsy, COPD, knee osteo-arthritis, low back pain, multiple 
sclerosis, Parkinson’s disease, renal transplant, rheumatoid arthritis, stroke, vestibular disorders, 
and frail elderly.83,84  Also, remote assessment (using videoconferencing) of these physical 
performance tests were determined to be safe, with no adverse events.85-87
A friend or family member is required to be present during the physical performance testing that 
is self-administered by the study participant in their own home. This friend or family member must 
be physically and mentally capable of providing support if needed, and have access to a telephone 
to request medical help, if needed. Additional protection against risks during the physical 
performance tests will include the following:

A fall assessment will be administered prior to the tests. Frequent fallers will require 2 
people to stand nearby the study participant during the tests to provide support if needed.

The chair used for the 30-second Chair Stand Test must include a straight back, not contain 
wheels, and be placed against a wall and unable to slide backwards or to the side.

For the balance tests, the participant will be asked to stand next to a wall or counter, 
which can be used to steady themselves before and during the tests. In addition to the 
wall or counter, a sturdy chair could be used on the other side, so the participant could 
reach out with both arms to steady themselves if needed.

Proper apparel and safety gear such as athletic shoes or orthopedic shoes, eye glasses (if 
needed), no jewelry or loose clothing that can catch on the chair or anything along the 
walking path.

No pets or small children that could interfere with the test and thus jeopardize the safety of 
the participant will be allowed within the space used to conduct the test (e.g., will need to 
be in a different room during testing).
Any serious adverse events that occur while the participant is enrolled in the study will be 
immediately communicated to Dr. Blair, who will confer with her mentoring team. All data 
will be used for research purposes and will be protected and kept strictly confidential. 
Although steps will be taken to ensure confidentiality of collected data, there is a very slight risk 
that data will inadvertently be released. 
14.0 Potential Benefits to Subjects
The current state of physical activity research is as follows: a) regular physical activity has 
numerous benefits; however, only a minority of older adults, including older cancer 
survivors, are physically active at the recommended levels, b) sedentary behavior, especially 
prolonged periods of uninterrupted sitting, has deleterious effects on health, even among 
individuals who exercise, and c) light-intensity activity is associated with better physical 

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health and psychosocial well-being. Since older cancer survivors spend up to 70% of waking 
hours in sedentary activities and seldom exercise, a potential benefit of participating in the 
proposed study is behavior change leading to increased light-intensity physical activity and 
reduced sedentary time. Additional potential benefits include improved physical function 
and quality of life. The proposed intervention is aimed at determining the feasibility and 
acceptability of a novel intervention to increase light-intensity activity throughout the day, 
ideally through at least minimal bouts of stepping each hour. If the intervention is feasible and 
acceptable to participants, and the data show promise, then this approach could be used to 
encourage inactive cancer survivors to adopt and maintain an active lifestyle, and may ultimately 
provide the impetus for further improvements in activity level through increased duration (longer 
bouts of continuous ambulation/activity) and/or intensity.
15.0 Vulnerable Populations
NA - this study is not enrolling individuals from vulnerable populations
16.0 Community-Based Participatory Research
NA - this study does not involve CBPR
17.0 Setting
This is a home-based intervention. The goal of the intervention is to increase light-intensity 
physical activity and reduce sedentary behavior throughout the day, every day.  The baseline and 
follow-up assessments will be conducted in the participants’ homes (self-assessment). 
The New Mexico Tumor Registry will be used to identify potential study participants and establish 
permission to contact.
Study staff will be housed in the Cancer Research Facility, where recruitment, screening, and 
health coach telephone contacts will take place. 
18.0 Resources Available
Study Personnel
Cindy K. Blair, PhD, Principal Investigator: Dr. Blair is an Associate Professor in the Division 
of Epidemiology, Biostatistics, and Preventive Health, in the School of Medicine as well as a 
member of the UNM Comprehensive Cancer Center (UNMCCC). Dr. Blair is a Cancer 
Epidemiologist and Behavioral Interventionist with 20 years of training, research experience, and 
collaborations in cancer epidemiology in general, and cancer survivorship and intervention 
development and implementation in particular. She has knowledge and experience with clinical 
trial design, recruitment and retention of study participants, data collection (subjective, objective, 
and biologic data), project management (observational studies, randomized controlled trials), 
supervising data collection staff and study coordinators, intervention tracking and delivery, and 
statistical analyses. Her background in epidemiology and biostatistics, and research experiences 

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have well prepared her to lead the proposed trial, coordinate all aspects of data collection and 
management, deliver the intervention, and conduct the statistical analyses.
19.0 Recruitment Methods
Recruitment
Potentially eligible cancer survivors will be identified via the New Mexico Tumor Registry 
(NMTR). Per current NMTR policy, a letter will be mailed to the cancer patient/survivor that 
explains the purpose of the NMTR and why the patient’s cancer diagnosis is collected/maintained 
by the registry. The letter also very briefly describes the proposed study and provides different 
options for contacting the NMTR if the patient does not want to be contacted by the study 
investigator. A recruitment flyer will be included with the letter. Passive consent is assumed if 
there is no response from the subject within three weeks of receiving the letter. Contact information 
for patients not refusing contact is then forwarded to the study investigator. 
Upon active or passive consent to contact, subjects will be mailed a letter explaining the study and 
inviting them to participate, a flyer, two consent forms (one to keep, one to mail back), and a self-
addressed, stamped envelope. Individuals not refusing contact will be telephoned by staff to 
discuss the study, verify eligibility, and begin the consent process. Written informed consent for 
those interested and study eligible will be obtained by having the participant mail the consent form 
(using a pre-addressed, postage paid envelope) to study staff after being consented via telephone. 
Study participants will be given a copy of the consent form to keep for their records. 
Note: The NMTR will be reviewing PHI (names, addresses, cancer diagnosis, etc.) from the tumor 
registry to identify potentially eligible subjects for the study. Therefore, we request a waiver of 
HIPAA authorization for screening/recruitment purposes. Note that individuals contacted by the 
NMTR on behalf of the study can refuse release of their contact information to the study team for 
additional contact and final determination of eligibility.
Individuals from previously completed studies who provided permission for future contact about 
new studies will receive a similar letter explaining the study and inviting them to participate and 
a study flyer. Individuals not refusing contact will be telephoned by staff to discuss the study, 
answer any questions, and verify eligibility. For interested and eligible individuals, they will 
either be mailed a copy of the consent form or receive a link to view the consent form via 
REDCap. Upon completion of the consent discussion, interested individuals will either 
electronically sign or sign and return the paper consent form. 
Sources of Materials
Study participants for this intervention will be recruited from The New Mexico Tumor Registry 
(NMTR). For enrollees, data on cancer type and stage, and age and year of diagnosis will be 
obtained from the NMTR. For non-enrollees, aggregate (de-identified) demographic (age, sex, 
race-ethnicity) and cancer data (type, stage, diagnosis year) will be obtained and used to compare 
characteristics of respondents with non-respondents (to assess potential selection bias). Data will 
be collected via mailed packets (activity monitors and questionnaires) at baseline, post-
intervention, and 3-months post-intervention. Data collection includes objective measures of light-
intensity physical activity and sedentary activity using the activPAL3 monitor. The ActivPAL3, 

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worn on the thigh, includes both a triaxial accelerometer and an inclinometer (to detect change in 
posture, i.e., sitting vs. upright posture) and is the gold standard in SB research. Participants will 
receive written instructions  on how to wear the activPAL monitors correctly and how to perform 
the physical performance tests correctly and safely. Subjective data will be collected on physical 
activity and sedentary activity (to provide context for objective data), health related quality of life, 
comorbidities, and sociodemographics. We will conduct a debriefing after the intervention to 
assess satisfaction with the program. 
20.0 Number of Subjects
Sixty-four, inactive, older cancer survivors will be randomized to either a 12-week 
theory-based intervention or a waitlist control.
21.0 Provisions to Protect the Privacy Interests of Subjects
Personal identifying information such as name and address will only be provided to the study from 
the NMTR for cancer survivors who did not object to contact by study staff. Subjects will then be 
contacted by mail with a letter introducing them to the intervention study and inviting them to 
participate. Subsequently, subjects will be contacted by telephone by research staff to summarize 
the goals of the study, answer questions, and assess final eligibility. 
During recruitment and the consent process, we will communicate to the study participant that 
their privacy is important, and what steps will be taken to protect their privacy. Examples include:

There is a very slight chance that someone else could get your personal information from 
us by accident. But to keep this from happening, we will keep all your personal information 
in a locked file cabinet or in password-protected computer files. 

Only key research personnel will be able to access your personal information. 

All data collected during the study will be identified with only a unique identifier.
The research team will not have access to medical records or other sensitive information not 
provided by the subject (self-reported medical conditions) or the NMTR (cancer site and stage, 
age at diagnosis, year of diagnosis, first course of therapy [surgery, chemotherapy and/or 
radiotherapy]). 
Only de-identified data will be used in data analyses. Only aggregate data will be used in 
presentations, reports, and publications. 
22.0 Compensation for Research-Related Injury
NA - this research study does not involve more than Minimal Risk to subjects
23.0 Economic Burden to Subjects
Participants will have minimal to no economic burden to participate because they will receive a 
stipend of $50 in the form of a merchandise card for each outcome assessment ($150 total). This 

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is to compensate participants for their time and to offset phone data charges. This is a sufficient 
amount as there will be no travel burden to participants and appointments will be made at their 
convenience. Additionally, participants will be gifted the FitBit Inspire 3 ($99) used throughout 
the intervention to maintain an active lifestyle upon completion of the study.
24.0 Consent Process
The subject will be introduced to the study through a mailed letter of invitation. The consent 
form will accompany the letter, to allow the subject adequate time to read the materials before 
study staff follow-up with a phone call (approximately 1 week later) to review the study and 
answer any questions, if the subject did not already call the toll-free study number. If the subject 
expresses interest in the study, final eligibility will be assessed, and verbal consent will be 
obtained. The following questions will be asked to assess the subjects’ understanding of the 
consent process. Do you have any questions about the study? We have covered a lot of 
information. Could you please describe for me what you think participating in this study 
requires? Do you have the toll free study telephone number?
The participant will be required to mail in the signed consent form (using a self-addressed 
postage paid envelope) before the baseline assessment can be scheduled. Each participant is 
allowed to choose when s/he begins the study, which allows for additional time to consider study 
participation, if needed. Research staff will be available via telephone to answer any questions 
that the subject may have. Additionally, staff will have received proper training in human 
subjects’ protection. The subject may decline participation in the study or drop out of the study at 
any time. This will be stated both verbally (phone call, home visit) and in writing (consent form). 
Contact information for the researchers, the Human Research Review Committee, and the 
Human Research Protections Office will be made available to potential participants. 
Study materials are translated into Spanish and the intervention will be offered in Spanish 
through our bilingual study team members. We modified this eligibility criteria in the 
recruitment script, so we can move our REDCap recruitment database from development to 
production mode. However, we will not start enrolling Spanish speakers until we have obtained 
HRRC approval for our Spanish study materials (anticipated in November or December of 
2022). 
25.0 Process to Document Consent in Writing
Either the PI, the Project Manager, or well-trained staff will obtain written informed consent 
from the study participants. Each participant will receive a copy of the signed consent form to 
keep for their records. 
26.0 Devices 
 
The activPAL3 activity-monitoring device (worn on the thigh):

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a) This is not a device study, i.e., this study does not evaluate the efficacy or safety of a device. 
There is no information on the FDA website regarding the activPAL3 monitor (NOTE: 
these monitors are from a company in Scotland, UK). The activPAL3 monitors are not 
investigational 
devices 
as 
they 
are 
commercially 
available 
(http://www.paltechnologies.com/); the shipment of activPAL3 monitors was cleared by 
the FDA and delivered to the Study PI. These monitors are the gold standard for objectively 
measuring sedentary behavior and ambulation in research study participants and have been 
used in many trials in the U.S. activPAL3 monitors are more expensive than consumer 
wearable monitors (e.g., FitBit, Jawbone) and require special software to analyze the data, 
thus these monitors are used in research rather than being purchased by consumers. In this 
study, the monitors are used to measure outcomes (frequency, duration, and intensity of 
free-living sedentary behavior and light physical activity), and are not used to diagnose or 
treat disease, or to support/sustain life. 
b) These monitors do not present a potential for serious risk to health, safety, or welfare of 
the subject. There is a potential for a small risk of skin irritation due to the adhesive used 
to attach the activPAL3 to the thigh. We are minimizing this risk by asking the research 
participants to check the monitors daily and if skin irritation occurs, to remove the monitor 
and contact study staff.  
c) The use of the activPAL3 monitors in this study poses non-significant risk per the FDA 
definition: i) it is not an implanted device, ii) it is not a life-sustaining/supporting device, 
iii) it is not “for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health”, and iv) it does not otherwise 
present “a potential for serious risk to the health safety, or welfare of a subject”. As 
mentioned earlier, the activPAL3 is an FDA cleared Class II medical device and is 
commercially available. 

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REFERENCES
1.
Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, 
Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, 
Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 
2012;62(4):220-241.
2.
Avis NE, Deimling GT. Cancer survivorship and aging. Cancer. 2008;113(12 
Suppl):3519-3529.
3.
Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield 
MR, Vaughn DJ, Panel ACSE. American Society of Clinical Oncology clinical evidence 
review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. 
J Clin Oncol. 2007;25(25):3991-4008.
4.
Deimling GT, Arendt JA, Kypriotakis G, Bowman KF. Functioning of older, long-term 
cancer survivors: the role of cancer and comorbidities. Journal of the American 
Geriatrics Society. 2009;57 Suppl 2:S289-292.
5.
Hewitt M, Rowland JH, Yancik R. Cancer survivors in the United States: age, health, and 
disability. J Gerontol A Biol Sci Med Sci. 2003;58(1):82-91.
6.
Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity 
function in persons over the age of 70 years as a predictor of subsequent disability. N 
Engl J Med. 1995;332(9):556-561.
7.
Onder G, Penninx BW, Ferrucci L, Fried LP, Guralnik JM, Pahor M. Measures of 
physical performance and risk for progressive and catastrophic disability: results from the 
Women's Health and Aging Study. The journals of gerontology Series A, Biological 
sciences and medical sciences. 2005;60(1):74-79.
8.
Penninx BW, Ferrucci L, Leveille SG, Rantanen T, Pahor M, Guralnik JM. Lower 
extremity performance in nondisabled older persons as a predictor of subsequent 
hospitalization. The journals of gerontology Series A, Biological sciences and medical 
sciences. 2000;55(11):M691-697.
9.
Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, 
Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, 
Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. 
JAMA. 2011;305(1):50-58.
10.
Aaronson NK, Mattioli V, Minton O, Weis J, Johansen C, Dalton SO, Verdonck-de 
Leeuw IM, Stein KD, Alfano CM, Mehnert A, de Boer A, van de Poll-Franse LV. 
Beyond treatment - Psychosocial and behavioural issues in cancer survivorship research 
and practice. EJC Suppl. 2014;12(1):54-64.
11.
Physical Activity Guidelines Advisory Committee. Physical Activity Guidelines 
Advisory Committee Report, 2008. Washington, DC: U.S. Department of Health and 
Human Services, 2008.:G6-1:G6-31.
12.
Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: 
examining opportunities for cancer control intervention. J Clin Oncol. 2005;23(34):8884-
8893.
13.
Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk 
factors among adult cancer survivors and noncancer controls. Prev Med. 2005;40(6):702-
711.

PROTOCOL TITLE: Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
Page 29 of 33
07/19/2023
14.
Eakin EG, Youlden DR, Baade PD, Lawler SP, Reeves MM, Heyworth JS, Fritschi L. 
Health behaviors of cancer survivors: data from an Australian population-based survey. 
Cancer Causes Control. 2007;18(8):881-894.
15.
Hamilton MT, Hamilton DG, Zderic TW. Role of low energy expenditure and sitting in 
obesity, metabolic syndrome, type 2 diabetes, and cardiovascular disease. Diabetes. 
2007;56(11):2655-2667.
16.
Hamilton MT, Healy GN, Dunstan DW, Zderic TW, Owen N. Too Little Exercise and 
Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on 
Sedentary Behavior. Curr Cardiovasc Risk Rep. 2008;2(4):292-298.
17.
Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, 
Bassett DR, Jr., Schmitz KH, Emplaincourt PO, Jacobs DR, Jr., Leon AS. Compendium 
of physical activities: an update of activity codes and MET intensities. Medicine and 
science in sports and exercise. 2000;32(9 Suppl):S498-504.
18.
Dunstan DW, Thorp AA, Healy GN. Prolonged sitting: is it a distinct coronary heart 
disease risk factor? Curr Opin Cardiol. 2011;26(5):412-419.
19.
Lyden K, Keadle SK, Staudenmayer J, Braun B, Freedson PS. Discrete features of 
sedentary behavior impact cardiometabolic risk factors. Med Sci Sports Exerc. 
2015;47(5):1079-1086.
20.
Healy GN, Winkler EA, Owen N, Anuradha S, Dunstan DW. Replacing sitting time with 
standing or stepping: associations with cardio-metabolic risk biomarkers. Eur Heart J. 
2015.
21.
Healy GN, Matthews CE, Dunstan DW, Winkler EA, Owen N. Sedentary time and 
cardio-metabolic biomarkers in US adults: NHANES 2003-06. Eur Heart J. 
2011;32(5):590-597.
22.
Henson J, Yates T, Edwardson CL, Khunti K, Talbot D, Gray LJ, Leigh TM, Carter P, 
Davies MJ. Sedentary time and markers of chronic low-grade inflammation in a high risk 
population. PloS one. 2013;8(10):e78350.
23.
Matthews CE, Moore SC, Sampson J, Blair A, Xiao Q, Keadle SK, Hollenbeck A, Park 
Y. Mortality Benefits for Replacing Sitting Time with Different Physical Activities. Med 
Sci Sports Exerc. 2015;47(9):1833-1840.
24.
Dunstan DW, Barr EL, Healy GN, Salmon J, Shaw JE, Balkau B, Magliano DJ, Cameron 
AJ, Zimmet PZ, Owen N. Television viewing time and mortality: the Australian 
Diabetes, Obesity and Lifestyle Study (AusDiab). Circulation. 2010;121(3):384-391.
25.
Seguin R, Lamonte M, Tinker L, Liu J, Woods N, Michael YL, Bushnell C, Lacroix AZ. 
Sedentary Behavior and Physical Function Decline in Older Women: Findings from the 
Women's Health Initiative. J Aging Res. 2012;2012:271589.
26.
Semanik PA, Lee J, Song J, Chang RW, Sohn MW, Ehrlich-Jones LS, Ainsworth BE, 
Nevitt MM, Kwoh CK, Dunlop DD. Accelerometer-monitored sedentary behavior and 
observed physical function loss. Am J Public Health. 2015;105(3):560-566.
27.
Buman MP, Hekler EB, Haskell WL, Pruitt L, Conway TL, Cain KL, Sallis JF, Saelens 
BE, Frank LD, King AC. Objective light-intensity physical activity associations with 
rated health in older adults. Am J Epidemiol. 2010;172(10):1155-1165.
28.
Blair CK, Morey MC, Desmond RA, Cohen HJ, Sloane R, Snyder DC, Demark-
Wahnefried W. Light-intensity activity attenuates functional decline in older cancer 
survivors. Med Sci Sports Exerc. 2014;46(7):1375-1383.

PROTOCOL TITLE: Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
Page 30 of 33
07/19/2023
29.
Reid N, Daly RM, Winkler EA, Gardiner PA, Eakin EG, Owen N, Dunstan DW, Healy 
GN. Associations of Monitor-Assessed Activity with Performance-Based Physical 
Function. PloS one. 2016;11(4):e0153398.
30.
Camhi SM, Sisson SB, Johnson WD, Katzmarzyk PT, Tudor-Locke C. Accelerometer-
determined moderate intensity lifestyle activity and cardiometabolic health. Prev Med. 
2011;52(5):358-360.
31.
Healy GN, Dunstan DW, Salmon J, Cerin E, Shaw JE, Zimmet PZ, Owen N. Objectively 
measured light-intensity physical activity is independently associated with 2-h plasma 
glucose. Diabetes Care. 2007;30(6):1384-1389.
32.
Healy GN, Wijndaele K, Dunstan DW, Shaw JE, Salmon J, Zimmet PZ, Owen N. 
Objectively measured sedentary time, physical activity, and metabolic risk: the Australian 
Diabetes, Obesity and Lifestyle Study (AusDiab). Diabetes Care. 2008;31(2):369-371.
33.
Healy GN, Winkler EA, Brakenridge CL, Reeves MM, Eakin EG. Accelerometer-derived 
sedentary and physical activity time in overweight/obese adults with type 2 diabetes: 
cross-sectional associations with cardiometabolic biomarkers. PloS one. 
2015;10(3):e0119140.
34.
Howard B, Winkler EA, Sethi P, Carson V, Ridgers ND, Salmon J, Healy GN, Owen N, 
Dunstan DW. Associations of Low- and High-Intensity Light Activity with 
Cardiometabolic Biomarkers. Med Sci Sports Exerc. in press.
35.
Thraen-Borowski KM, Trentham-Dietz A, Edwards DF, Koltyn KF, Colbert LH. Dose-
response relationships between physical activity, social participation, and health-related 
quality of life in colorectal cancer survivors. J Cancer Surviv. 2013.
36.
Alfano CM, Bluethmann SM, Tesauro G, Perna F, Agurs-Collins T, Elena JW, Ross SA, 
O'Connell M, Bowles HR, Greenberg D, Nebeling L. NCI Funding Trends and Priorities 
in Physical Activity and Energy Balance Research Among Cancer Survivors. J Natl 
Cancer Inst. 2016;108(1).
37.
Goode AD, Lawler SP, Brakenridge CL, Reeves MM, Eakin EG. Telephone, print, and 
Web-based interventions for physical activity, diet, and weight control among cancer 
survivors: a systematic review. J Cancer Surviv. 2015;9(4):660-682.
38.
Hart LG, Larson EH, Lishner DM. Rural definitions for health policy and research. Am J 
Public Health. 2005;95(7):1149-1155.
39.
USDA Economic Research Service: Rural-Urban Commuting Area (RUCA) Codes - 
Documentation. https://www.ers.usda.gov/data-products/rural-urban-commuting-area-
codes/documentation/. Accessed January 1, 2019.
40.
WWAMI RUCA Rural Health Research Center: Rural-Urban Commuting Area (RUCA) 
Codes http://depts.washington.edu/uwruca/. Accessed.
41.
PAL Technologies LTD, Glasgow, Scotland, UK.
42.
Craft LL, Zderic TW, Gapstur SM, Vaniterson EH, Thomas DM, Siddique J, Hamilton 
MT. Evidence that women meeting physical activity guidelines do not sit less: an 
observational inclinometry study. Int J Behav Nutr Phys Act. 2012;9:122.
43.
Dunstan DW, Wiesner G, Eakin EG, Neuhaus M, Owen N, LaMontagne AD, Moodie M, 
Winkler EA, Fjeldsoe BS, Lawler S, Healy GN. Reducing office workers' sitting time: 
rationale and study design for the Stand Up Victoria cluster randomized trial. BMC public 
health. 2013;13:1057.
44.
Gennuso KP, Gangnon RE, Matthews CE, Thraen-Borowski KM, Colbert LH. Sedentary 
behavior, physical activity, and markers of health in older adults. Med Sci Sports Exerc. 
2013;45(8):1493-1500.

PROTOCOL TITLE: Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
Page 31 of 33
07/19/2023
45.
Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald 
B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, 
Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For 
older adults and special populations. Int J Behav Nutr Phys Act. 2011;8:80.
46.
Buman MP, Winkler EA, Kurka JM, Hekler EB, Baldwin CM, Owen N, Ainsworth BE, 
Healy GN, Gardiner PA. Reallocating time to sleep, sedentary behaviors, or active 
behaviors: associations with cardiovascular disease risk biomarkers, NHANES 2005-
2006. Am J Epidemiol. 2014;179(3):323-334.
47.
Healy GN, Dunstan DW, Salmon J, Cerin E, Shaw JE, Zimmet PZ, Owen N. Breaks in 
sedentary time: beneficial associations with metabolic risk. Diabetes Care. 
2008;31(4):661-666.
48.
Peddie MC, Bone JL, Rehrer NJ, Skeaff CM, Gray AR, Perry TL. Breaking prolonged 
sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized 
crossover trial. Am J Clin Nutr. 2013;98(2):358-366.
49.
Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, 
Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces 
postprandial glucose and insulin responses. Diabetes Care. 2012;35(5):976-983.
50.
Schwalbe CS, Oh HY, Zweben A. Sustaining motivational interviewing: a meta-analysis 
of training studies. Addiction. 2014;109(8):1287-1294.
51.
Walters ST, Matson SA, Baer JS, Ziedonis DM. Effectiveness of workshop training for 
psychosocial addiction treatments: A systematic review. J Subst Abuse Treat. 
2005;29(4):283-293.
52.
Moyers TB, Manuel JK, Ernst D. Motivational interviwing treatment integrity coding 
manual (MITI 4.1). In:2014.
53.
Godin G, Shepard RJ. A simple method to assess exercise behavior in the community. 
Can J Appl Sport Sci. 1985;10:141-146.
54.
Rosenberg DE, Norman GJ, Wagner N, Patrick K, Calfas KJ, Sallis JF. Reliability and 
validity of the Sedentary Behavior Questionnaire (SBQ) for adults. J Phys Act Health. 
2010;7(6):697-705.
55.
PAL Technologies LTD, Glasgow, UK.
56.
Lyden K, Kozey Keadle SL, Staudenmayer JW, Freedson PS. Validity of two wearable 
monitors to estimate breaks from sedentary time. Med Sci Sports Exerc. 
2012;44(11):2243-2252.
57.
Ryan CG, Grant PM, Tigbe WW, Granat MH. The validity and reliability of a novel 
activity monitor as a measure of walking. Br J Sports Med. 2006;40(9):779-784.
58.
Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson PS. Validation of 
wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 
2011;43(8):1561-1567.
59.
Dahlgren G, Carlsson D, Moorhead A, Hager-Ross C, McDonough SM. Test-retest 
reliability of step counts with the ActivPAL device in common daily activities. Gait 
Posture. 2010;32(3):386-390.
60.
Abel M, Hannon J, Mullineaux D, Beighle A. Determination of step rate thresholds 
corresponding to physical activity intensity classifications in adults. J Phys Act Health. 
2011;8(1):45-51.
61.
Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, Hatano 
Y, Inoue S, Matsudo SM, Mutrie N, Oppert JM, Rowe DA, Schmidt MD, Schofield GM, 

PROTOCOL TITLE: Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
Page 32 of 33
07/19/2023
Spence JC, Teixeira PJ, Tully MA, Blair SN. How many steps/day are enough? For 
adults. Int J Behav Nutr Phys Act. 2011;8:79.
62.
PROMIS: Patient-Reported Outcomes Measurement Information System. 
http://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis. 
Accessed.
63.
Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, 
Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. 
PROMIS((R)) Adult Health Profiles: Efficient Short-Form Measures of Seven Health 
Domains. Value Health. 2019;22(5):537-544.
64.
Cook KF, Jensen SE, Schalet BD, Beaumont JL, Amtmann D, Czajkowski S, Dewalt 
DA, Fries JF, Pilkonis PA, Reeve BB, Stone AA, Weinfurt KP, Cella D. PROMIS 
measures of pain, fatigue, negative affect, physical function, and social function 
demonstrate clinical validity across a range of chronic conditions. J Clin Epidemiol. 
2016.
65.
Schalet BD, Hays RD, Jensen SE, Beaumont JL, Fries JF, Cella D. Validity of PROMIS 
physical function measures in diverse clinical samples. J Clin Epidemiol. 2016.
66.
Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. 
Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical 
samples. J Clin Epidemiol. 2016.
67.
Fillenbaum GG. Multidimensional Functional Assessment of Older Adults: The Duke 
Older Americans Resources and Services Procedures. Hillsdale, NJ: Lawrence Erlbaum 
Associates; 1988.
68.
Sallis JF, Pinski RB, Grossman RM, Patterson TL, Nader PR. The development of self-
efficacy scales for health related diet and exercise behaviors. Health Educ Res. 
1988;3(3):283-292.
69.
McAuley E, Motl RW, White SM, Wojcicki TR. Validation of the multidimensional 
outcome expectations for exercise scale in ambulatory, symptom-free persons with 
multiple sclerosis. Arch Phys Med Rehabil. 2010;91(1):100-105.
70.
Wojcicki TR, White SM, McAuley E. Assessing outcome expectations in older adults: 
the multidimensional outcome expectations for exercise scale. J Gerontol B Psychol Sci 
Soc Sci. 2009;64(1):33-40.
71.
Markland D, Tobin V. A modification of the Behavioral Regulation in Exercise 
Questionnaire to include an assessment of amotivation. Journal of Sport and Exercise 
Psychology. 2004;26:P191-196.
72.
Murcia JA, Gimeno EC, Camacho AM. Measuring self-determination motivation in a 
physical fitness setting: validation of the Behavioral Regulation in Exercise 
Questionnaire-2 (BREQ-2) in a Spanish sample. J Sports Med Phys Fitness. 
2007;47(3):366-374.
73.
Litttle R, Rubin DB. Statistical Analysis with Missing Data. 2 ed. Wiley-Interscience, 
Hoboken, NJ, 2002.
74.
Choi L, Ward SC, Schnelle JF, Buchowski MS. Assessment of wear/nonwear time 
classification algorithms for triaxial accelerometer. Med Sci Sports Exerc. 
2012;44(10):2009-2016.
75.
Winkler EA, Bodicoat DH, Healy GN, Bakrania K, Yates T, Owen N, Dunstan DW, 
Edwardson CL. Identifying adults' valid waking wear time by automated estimation in 
activPAL data collected with a 24 h wear protocol. Physiol Meas. 2016;37(10):1653-
1668.

PROTOCOL TITLE: Whole-of-Day Approach to Physical Activity in Older Cancer Survivors
Page 33 of 33
07/19/2023
76.
Clark BK, Lynch BM, Winkler EA, Gardiner PA, Healy GN, Dunstan DW, Owen N. 
Validity of a multi-context sitting questionnaire across demographically diverse 
population groups: AusDiab3. Int J Behav Nutr Phys Act. 2015;12:148.
77.
Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity 
in the United States measured by accelerometer. Med Sci Sports Exerc. 2008;40(1):181-
188.
78.
Healy GN, Clark BK, Winkler EA, Gardiner PA, Brown WJ, Matthews CE. 
Measurement of adults' sedentary time in population-based studies. Am J Prev Med. 
2011;41(2):216-227.
79.
Wilmot EG, Davies MJ, Edwardson CL, Gorely T, Khunti K, Nimmo M, Yates T, Biddle 
SJ. Rationale and study design for a randomised controlled trial to reduce sedentary time 
in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes). 
BMC public health. 2011;11:908.
80.
Matthews CE, Hagstromer M, Pober DM, Bowles HR. Best practices for using physical 
activity monitors in population-based research. Med Sci Sports Exerc. 2012;44(1 Suppl 
1):S68-76.
81.
Montoye AH, Moore RW, Bowles HR, Korycinski R, Pfeiffer KA. Reporting 
accelerometer methods in physical activity intervention studies: a systematic review and 
recommendations for authors. Br J Sports Med. 2016.
82.
Edwardson CL, Winkler EA, Bodicoat DH, Yates T, Davies MJ, Dunstan DW, Healy 
GN. Considerations when using the activPAL monitor in field-based research with adult 
populations. J Sport Health Sci. in press (http://dx.doi.org/10.1016/j.jshs.2016.02.002).
83.
Rehabilitation Measures Database. Rehab Measures: 30 Second Sit to Stand Test. 
http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=1015. 
Accessed.
84.
Rehabilitation Measures Database. Rehab Measures: Timed Up and Go. 
http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=903. Accessed.
85.
Guidarelli C, Lipps C, Stoyles S, Dieckmann NF, Winters-Stone KM. Remote 
administration of physical performance tests among persons with and without a cancer 
history: Establishing reliability and agreement with in-person assessment. J Geriatr 
Oncol. 2022;13(5):691-697.
86.
Hoenemeyer TW, Cole WW, Oster RA, Pekmezi DW, Pye A, Demark-Wahnefried W. 
Test/Retest Reliability and Validity of Remote vs. In-Person Anthropometric and 
Physical Performance Assessments in Cancer Survivors and Supportive Partners. 
Cancers (Basel). 2022;14(4).
87.
Blair CK, Harding E, Herman C, Boyce T, Demark-Wahnefried W, Davis S, Kinney AY, 
Pankratz VS. Remote Assessment of Functional Mobility and Strength in Older Cancer 
Survivors: Protocol for a Validity and Reliability Study. JMIR Res Protoc. 
2020;9(9):e20834.