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Receive no physical activity intervention (maintain baseline physical activity participation)

Receive an intervention of 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve for 12 weeks.

Receive an intervention of 150 minutes/week of physical activity at an intensity of 60-80% of heart rate reserve for 12 weeks.

Prescription of 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve

Lighter intensity physical activity intervention

Prescription of 150 minutes/week of physical activity at an intensity of 60-80% of heart rate reserve

Higher intensity physical activity intervention

Christine Friedenreich, PhD

Jessica McNeil, PhD

The Breast Cancer \& Physical Activity Level (BC-PAL) pilot study is a randomized controlled pilot trial aimed at evaluating whether total physical activity levels, health-related fitness and patient reported outcomes are improved by promoting different intensities of physical activity participation within a home-based setting, and whether these improvements are maintained over the long-term, in inactive breast cancer survivors.

Detailed Description

Rationale and Significance:

Breast cancer is the most common cancer among Canadian women. Physical activity has emerged as a potential lifestyle factor for improving rehabilitation and survival after breast cancer. The American Cancer Society recommends that cancer survivors engage in at least 150 minutes of moderate-vigorous intensity physical activity per week. However, only ≈ 15% of breast cancer survivors reported meeting these physical activity guidelines. Therefore, interventions that promote physical activity behavior change in an unsupervised/home-based setting are needed to provide the necessary tools and support for breast cancer survivors. No study to date has assessed the effects of a lighter intensity physical activity intervention, compared to no additional physical activity prescription (control) or a higher intensity physical activity intervention (comparable to current exercise guidelines), in inactive breast cancer survivors, in addition to the longer-term maintenance effects of these interventions.

Study Aims:

Aim 1: To evaluate the effects of prescribing an additional 300 minutes/week of lighter intensity physical activity (LIPA) or 150 minutes/week of higher intensity physical activity (HIPA) versus no physical activity intervention (control) on total physical activity and sedentary time in inactive breast cancer survivors.

Aim 2: To evaluate the effects of prescribing an additional 300 minutes/week of LIPA or 150 minutes/week of HIPA versus control on markers of health-related fitness (anthropometric measures, body composition, cardio-respiratory fitness) and patient reported outcomes (quality of life, sleep quality, feelings of happiness, perceived feelings of depression) in inactive breast cancer survivors.

Aim 3: To evaluate the longer-term (24-week) maintenance effect of prescribing an additional 300 minutes/week of LIPA or 150 minutes/week of HIPA versus control on our primary and secondary outcomes.

Research Plan:

A three-armed, 12-week pilot randomized controlled trial followed by a 12-week follow-up measurement is proposed. All eligible and interested women are invited to contact and meet with study staff at the Holy Cross Center in Calgary, at which time the study protocol is explained, informed consent obtained and baseline questionnaires distributed. These questionnaires assess: demographic characteristics, sleep quality, perceived health-related quality of life, feelings of happiness and perceived feelings of depression. At the end of this first meeting, participants are asked to wear an Actigraph GTX3® accelerometer for seven days to assess baseline physical activity levels. During a second meeting at the Holy Cross Center, accelerometers are returned to study staff, anthropometric data (height, weight, waist and hip circumferences and body composition) are collected and a maximal treadmill test (modified Balke protocol) is conducted. Participants are then randomized, using a 1:1:1 allocation, into either the control (no intervention), lighter intensity or the higher intensity physical activity interventions. The control group is instructed to maintain baseline physical activity participation. The lighter intensity physical activity (LIPA) group is instructed to accumulate 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve. The higher intensity physical activity (HIPA) group is instructed to accumulate 150 minutes of physical activity at an intensity of 60-80% of heart rate reserve. Participants randomized to the LIPA and HIPA groups are given: 1) instructions on physical activity safety and goal setting, proper heart rate monitoring and stretching techniques that should be completed before and after physical activity participation; 2) a publicly-available physical activity guidebook for breast cancer survivors; 3) a Polar A360® device to track heart rate and physical activity time throughout the intervention. Data collected by this device are uploaded to the Polar Flow® application by syncing with a smart phone or a computer with a provided USB cord. Participants are asked to upload their data at least once per week. If a participant does not own a computer or a smart phone, or prefers that the study staff upload these data for them, in-person meetings are arranged to do so. Participants in the LIPA and HIPA groups are also asked to rate the feasibility of achieving the prescribed physical activity targets and record strategies used and barriers encountered during the intervention in a diary. In-person/telephone meetings with these participants occur every three weeks to review data from the Polar A360® device and diary, to reinforce progress/good adherence and discuss/solve any problems or barriers to achieving the prescribed physical activity goals. During weeks 12 (final intervention week) and 24 (final week of the follow-up period), all participants wear an Actigraph GTX3® accelerometer to assess physical activity volume. At the end of weeks 12 (end of the intervention) and 24 (end of the follow-up period), all participants repeat baseline measurements and questionnaires, except for items on demographic characteristics.

The investigators will use intention-to-treat statistical analysis on all participants with follow-up data regardless of adherence to the interventions. An analysis of covariance (ANCOVA) will be used to compare between-group differences in study outcomes at 12- and 24-weeks, compared to baseline, after adjusting for baseline outcomes values.

This pilot randomized controlled trial will provide data on the feasibility of prescribing different physical activity intensities within a home-based setting to increase total physical activity time, reduce sedentary time and improve health outcomes in breast cancer survivors. The investigators will use these data to help design and conceptualize a larger-scale randomized controlled trial.

Participants are randomized, using a 1:1:1 allocation, into one of three groups: 1) the control group (no physical activity intervention), 2) the lighter intensity physical activity intervention or 3) the higher intensity physical activity intervention.

The Breast Cancer & Physical Activity Level (BC-PAL) Pilot Study

Pittsburgh Sleep Quality Index will be used to measure the total aggregate score from the questionnaire on a scale of 0-21, with 21 indicating worst sleep quality

The Medical Outcomes Study Short Form-12 Survey will be used to measure mental component aggregate score and physical component aggregate score, each on a scale of 0-100, with a higher score indicating higher function, well-being or quality of life. The questions on physical functioning, role-physical limitations and bodily pain are summed to provide the physical aggregate score. The questions on social functioning, vitality, role-emotional limitations and mental health are summed to provide the mental aggregate score.

The Functional Assessment of Cancer Therapy-Breast Questionnaire will be used to measure total score ranges from 0 to 28, with a higher score indicating higher function, well-being or quality of life. The results from each question are summed to provide the total score.

The Happiness Scale will be used to assess happiness with one question asking participants what is the average level of happiness over the past 7 days on a scale of 1 (extremely happy) to 11 (extremely unhappy). A second question asks participants what is the percentage of time spent happy (value in % over the last 7 days), neutral (value in % over the last 7 days) and unhappy (value in % over the last 7 days).

The Patient Health Questionnaire provides a score of 0 to 27, with a higher score indicating higher feelings of depression. The results from each question are summed to provide the total score.

Measured with accelerometry over seven days

Measured with an anthropometric measuring tape

Measured by Dual X-ray Absorptiometry (DXA)

Measured by maximal cardiorespiratory fitness test using the multistage, modified Balke treadmill protocol

Weight and height will be combined to report BMI

University of Calgary

AHS Cancer Control Alberta

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

The primary goal of the Sit Less arm is to reduce the total amount of time spent sitting each day and break up prolonged bouts of sitting.

The Sit Less arm uses habit formation, social cognitive theory, and motivational interviewing techniques to support behavior change and includes: 1) 7 health coaching sessions to set personalized goals and review progress; 2) wearing an activPAL (thigh worn accelerometer that measures sitting time); 3) intervention tools to support behavior change (e.g., standing desk, wrist worn monitor).

Behavioral: Sit Less

This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.

Many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. This is known as accelerated aging. One way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. Another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. Long periods of sitting are related to many physical and health problems. Cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. This study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.

RISE - Reduce Sitting Time Among Breast Cancer Survivors

RISE - A Pilot Study to Reduce Sitting Time Among Breast Cancer Survivors

Percent of participants returning for the 3 month measures

Measure of Self-Report Physical Function, standardized T-score, higher scores indicated better functioning

University of California, San Diego

Associate Professor

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Tests the effect of a multi-component mobile health (mHealth) intervention on reducing sedentary behavior among adolescents with ALL during maintenance therapy. The intervention includes an app-based peer support group for study participants via WhatsApp, individualized coaching sessions with study staff, and prompts to move delivered via a Fitbit wearable fitness tracker.

Sedentary time intervention

Brittany J Van Remortel, MD, MPH

David R Freyer, DO, MS

The goal of this randomized clinical trial is to test if a mobile health intervention, including a wearable fitness tracker with reminders to move, individualized coaching sessions, and an app-based peer support group, can decrease sedentary time (time spent sitting/lying down and inactive) in adolescents with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy. The main questions it aims to answer are:

* Is the intervention a feasible and acceptable way to decrease sedentary time among adolescents with ALL?
* Does the intervention show evidence that it may decrease sedentary time, increase quality of life, and improve blood glucose control and inflammation?

Participants in the intervention group will use their fitness tracker with reminders to move as well as support from other intervention participants and coaching with study staff to gradually decrease their sedentary time over 10 weeks. Researchers will compare the intervention group to a control group that receives education only to see if the intervention may be helpful to decrease sedentary time in adolescents with ALL. All participants will wear an activity tracker on the thigh for 7 days at the beginning and end of the study as well as complete quality of life questionnaires. Study labs will be collected three times (monthly) over the course of the 12-week study. All in-person study visits and labs will occur in conjunction with Oncology clinic visits for maintenance chemotherapy.

Sedentary behaviors are highly prevalent among adolescents with acute lymphoblastic leukemia (ALL) and may worsen the cardiometabolic effects and deconditioning commonly associated with therapy. Replacing sedentary time (ST) with short bouts of light activity has been shown to reduce adiposity and improve glucose metabolism. This randomized, controlled pilot trial tests the feasibility and acceptability of a 10-week, multi-component mobile health ST intervention in adolescents with ALL and will inform future larger studies. Thirty participants will be enrolled and randomized to the intervention or control group. The intervention group will receive a wearable fitness tracker with prompts to move and participate in an app-based peer support group and individualized coaching sessions. The control group will receive educational materials only. Primary endpoints are intervention feasibility and acceptability. As secondary endpoints, this trial will also evaluate trends of efficacy of the intervention to: 1)reduce device-measured and self-reported ST, 2)improve short-term glucose metabolism and inflammation, and 3) improve health-related quality of life and fatigue among intervention versus control participants. Feasibility will be measured by recruitment rate, fitness tracker wear time, and retention rate; acceptability will be measured quantitatively via study exit surveys and qualitatively among intervention participants with exit interviews. Interim analysis will be completed once half of the enrollment goal has been reached (15) in order to inform future study, and final analysis will be completed once all 30 participants have completed.

Reduce Sedentary Time (ReSeT) in Acute Lymphoblastic Leukemia (ALL)

ReSeT in ALL: A Randomized Controlled Pilot Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents With ALL During Maintenance Therapy

Recruitment rate will serve as one of the primary markers of study feasibility to inform future trials. Number of participants recruited per week will be tracked to calculate the total participants enrolled at 6 months.

Retention rate will also be a defining measure of study feasibility. Number of participants who complete all questionnaires at baseline and 12 weeks will be divided by the total number of participants to determine the retention rate.

Fitness tracker (Fitbit) wear time for each participant will be measured by the number of hours per day with detectable heart rate measurement. Total hours of fitness tracker wear time will be divided by total number of intervention days to calculate average daily wear time.

Participant acceptability of the sedentary time intervention will be assessed via exit surveys and semi-structured qualitative interviews with study participants at the end of the 12-week study period. The exit survey will assess participants' opinions on the perceived effectiveness of the intervention overall, as well as each intervention component (Fitbit with reminders to move, coaching sessions, app-based per support group), via Likert-scale questions.

Sedentary time will be measured using an activity monitor applied to the right thigh (ActivPAL accelerometer) that tracks how much time someone spends in low-intensity activities done while sitting or lying down (sedentary behaviors) over a 7-day period. Total minutes of sedentary time acquired will be divided by the number of valid accelerometer wear days to calculate the average minutes of sedentary time per day, which will be compared from baseline to post-intervention.

For all participants, sedentary time will be measured using an activity monitor applied to the right thigh (ActivPAL accelerometer) that tracks how much time someone spends in low-intensity activities done while sitting or lying down (sedentary behaviors) over a 7-day period. An uninterrupted sedentary hour will be defined as an hour with \<250 steps. Total hours of uninterrupted sedentary time acquired will be divided by valid accelerometer wear days to calculate the average hours of uninterrupted sedentary time per day, which will be compared from baseline to post-intervention.

A non-fasting blood sample (up to 2 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0) and post-intervention (Week 12) for measurement of hemoglobin A1c, which provides an average of blood glucose trends over the past 2-3 months.

A non-fasting blood sample (up to 2 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 4, and post-intervention (Week 12) for measurement of fructosamine, which provides an average of blood glucose trends over the past 2-4 weeks. Fructosamine level at 4 weeks will be compared to the baseline level.

A non-fasting blood sample (up to 2 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 4, and post-intervention (Week 12) for measurement of fructosamine, which provides an average of blood glucose trends over the past 2-4 weeks. Fructosamine level at 12 weeks will be compared to the baseline level.

A non-fasting blood sample (up to 1 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 4, and post-intervention (Week 12) for measurement of CRP, which is a general marker of bodily inflammation. CRP level at 4 weeks will be compared to the baseline level.

A non-fasting blood sample (up to 1 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 4, and post-intervention (Week 12) for measurement of CRP, which is a general marker of bodily inflammation. CRP level at 12 weeks will be compared to the baseline level.

Self-reported HRQOL will be measured with the 23-item Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales (physical functioning, emotional functioning, social functioning, and school functioning) and 27-item PedsQL 3.0 Cancer Module (pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). Items are reversed scored and linearly transformed on a scale from 0 to 100, with higher scores indicating better HRQOL and fewer problems or symptoms. Participant's scores at 12 weeks will be compared to the baseline score.

Self-reported fatigue will be measured with the 18-item Pediatric Quality of Life inventory (PedsQL) 3.0 Multidimensional Fatigue Scale (general fatigue, sleep/rest fatigue, cognitive fatigue). Items are reversed scored and linearly transformed on a scale from 0 to 100, with higher scores indicating better HRQOL and fewer problems or symptoms. Participant's scores at 12 weeks will be compared to the baseline score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Breast Cancer & Physical Activity Level (BC-PAL) Pilot Study	NCT03564899	Breast Cancer S...	Lighter intensi... Higher intensit...	18 Years -	AHS Cancer Control Alberta
The Breast Cancer & Physical Activity Level (BC-PAL) Pilot Study	NCT03564899	Breast Cancer S...	Lighter intensi... Higher intensit...	18 Years -	AHS Cancer Control Alberta
RISE - Reduce Sitting Time Among Breast Cancer Survivors	NCT05260723	Sedentary Behav... Sedentary Time Breast Cancer	Behavioral: Sit...	50 Years -	University of California, San Diego
Reduce Sedentary Time (ReSeT) in Acute Lymphoblastic Leukemia (ALL)	NCT06182163	Acute Lymphobla...	Sedentary time ...	12 Years - 18 Years	Children's Hospital Los Angeles
Reduce Sedentary Time (ReSeT) in Acute Lymphoblastic Leukemia (ALL)	NCT06182163	Acute Lymphobla...	Sedentary time ...	12 Years - 18 Years	Children's Hospital Los Angeles

Spots Global Cancer Trial Database for sedentary time