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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

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Obesity

Women randomized to the "connected device" arm will follow a 6-month exercise program using a connected device that includes an activity tracker and subscription to an exercise and physical activity management program through a smartphone application and a website. They will also receive international recommendations on physical activity.

Women randomized to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education. They will also receive international recommendations on physical activity.

Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity.

Women will receive standard care, i.e., international recommendations on physical activity, without further intervention.

Women will receive a connected wristband (https://www.carefitness.com/) and a subscription to a smartphone application and website (http://disco.biomouv.com/). They will have to participate in a 6-month personalized non-supervised exercise program consisting of 3 weekly sessions of 20 min to 1-hr of moderate-to-vigorous physical activity (≥3 METs): 2 sessions of brisk walking and 1 session of muscle strengthening. Women should wear the wristband daily to track their number of steps (automatic Bluetooth synchronization to the application). Duration and intensity of sessions and target number of daily steps will progressively increase (+15% up to 10,000 steps) to place the patients in a progression dynamic. Women will receive phone-based follow-up at 1 week, 2 months, and 4 months.

Connected device

Women will be invited to participate in the 6-month therapeutic patient education program "Mieux manger, mieux bouger" ("Eat better, move better") elaborated at the Léon Bérard cancer center. The program consists in four sessions:

* a 1-hour individual session of "educational diagnosis" to assess their needs and establish a contract of objectives,
* two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum to improve their daily practice of physical activity,
* a 1-hour individual session of "educational assessment" to evaluate whether their objectives were reached.

Therapeutic education

Béatrice Fervers, MD, PhD

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Rationale:

In women with breast cancer, weight gain, obesity, and lack of physical activity have been shown to increase the risk of comorbidities and deleterious long-term outcomes. Despite the safety of physical activity and the benefits of physical activity performed concomitant to treatment on fatigue, quality of life, and possibly survival, its implementation is not systematic in the cancer care pathway.

Methods:

The DISCO study is a randomized, controlled, multicenter intervention study that will be conducted among 432 women treated for localized breast cancer. Patients will be randomly assigned to one of the four arms of the study according to a 1:1:1:1 ratio.

* Women allocated to the "connected device" arm will benefit from a 6-month personalized exercise program consisting of three weekly sessions of aerobic and strength exercises, carried out autonomously with a connected device (wristband, smartphone application, website).
* Women allocated to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education.
* Women allocated to the "combined" arm will benefit from both interventions in parallel.
* Women allocated to the "control" arm will receive standard care, i.e., international recommendations on physical activity.

Evaluations will be conducted at inclusion (T1, baseline), 6 months (T2, end of interventions), and 12 months (T3, 12 months post-inclusion to study maintenance of behavior change) on the following parameters: level of physical activity and sedentary behavior (RPAQ self-administered questionnaire), physical condition assessed by functional tests (6-min walking test, sit-to-stand test, hang-grip test, sit-and-reach flexibility test, single-leg balance test), anthropometrics (weight, height, waist circumference, hip circumference, calculated body mass index), body composition (fat mass, lean body mass, fat free mass, water), biological factors (blood sample at baseline and 6 months), lifestyle factors (tobacco status, alcohol intake), psychological factors (quality of life assessed by the EORTC QLQ-C30 / BR-23 questionnaire, health-related quality of life assessed by the EQ-5D-5L questionnaire, fatigue assessed by the PFS-12 questionnaire), socio-economic parameters (social deprivation assessed by the EPICES questionnaire, level of education, family situation, professional status assessed through a self-administered questionnaire). Clinical data will be obtained from patients' medical records. Acceptability of connected device and of therapeutic education program will be assessed within the population. The medico-economic impact of the interventions will be evaluated through cost-utility and cost-effectiveness analyses. Data will be recorded using an e-CRF. Women will be recruited over 2 years and will be followed up for 12 months.

Hypothesis:

The research hypothesis is that patients participating in the 6-month intervention with the connected device or in the 6-month therapeutic education program will be more likely to achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Expected results are to identify best modalities to implement exercise during and after breast cancer treatment. In a public health perspective, the challenge is to reduce geographical, social, and organizational inequalities among patients to practice regular physical activity and to promote the systematic integration of physical activity in routine cancer care.

Two interventions, each alone and in combination, are evaluated in parallel against a control group. Women assigned to the "connected device" arm will follow a 6-month exercise program using a connected device. Women assigned to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education in physical activity. Women assigned to the "combined" arm will follow both programs. Women assigned to the "control" arm will receive international recommendations on physical activity.

Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer

Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

The cost-utility of implementing each intervention will be assessed.

The cost-effectiveness of implementing each intervention will be assessed.

Assessed by the RPAQ self-administered questionnaire

Time spent in different intensities of physical activity, time spent in sedentary activities

weight in kilograms and height in meters will be combined to report BMI in kg/m\^2

fat mass measured using bioelectronic impedancemetry

lean body mass measured using bioelectronic impedancemetry

fat free mass measured using bioelectronic impedancemetry

water measured using bioelectronic impedancemetry

EORTC QLQ-C30 questionnaire and its BR-23 module

Change in professional status, return to work, and perceived difficulty at work by a self-administered questionnaire.

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
Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer	NCT03529383	Breast Cancer	Connected devic... Therapeutic edu...	18 Years - 75 Years	Centre Leon Berard

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