Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients (MIPAClux)
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|ClinicalTrials.gov Identifier: NCT03210129|
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : March 14, 2019
Physical activity is not only efficient for primary prevention of several cancer types, but it also plays an important role in cancer survivors. Physical activity after a cancer diagnosis has been associated with reduced overall and cancer-specific mortality. It has significant positive effects on physical fitness and several cancer-related symptoms including fatigue, sleep disturbance, depression and anxiety. The evidence is considerable and consistent for breast, colorectal and endometrial cancers. However, patients are generally insufficiently active, and participation rates in physical activity opportunities offered by specialized organizations are low. This pilot study will evaluate the feasibility, efficacy and cost-effectiveness of an intervention seeking to increase active lifestyle and physical activity participation of cancer patients. To encourage this behavioural change, motivational interviewing will be used, a patient-centred approach aimed at increasing the patients' motivation for a behavioural change through open-ended discussions.
Seventy patients with breast, colorectal or endometrial cancer will be recruited within a time period of 12 months. Patients will be randomly assigned to an intervention or a control group. The intervention group will receive standard care alongside 12 motivational interviewing sessions within 12 weeks. The control group will receive standard care only. Physical activity behaviour (3D-accelerometer) and physical fitness (cardiovascular and strength fitness) will be measured in the week preceding and following the intervention. Additionally, a subgroup from both study arms will be assessed 12 weeks after the completion of the intervention. The investigators hypothesize that sedentary time will decrease and time spent in moderate and vigorous physical activity, physical fitness and quality of life of cancer survivors will increase to a greater extent in the intervention group than in the control group. Furthermore, health-related quality of life and resource use (intervention and healthcare costs, out of pocket costs) will be measured to evaluate the cost-effectiveness of the intervention.
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Breast Cancer of Colon Endometrial Cancer||Behavioral: Motivational interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The patients will be randomly assigned to the experimental group with motivational interviewing or the control group. Group assignment will be done by a motivational interviewing counsellor using randomization lists generated by the Competence Center in Methodology and Statistics (Luxembourg Institute of Health). For each type of cancer, a separate randomisation list will be used.|
|Masking:||Double (Investigator, Outcomes Assessor)|
Every patient will be given a person-specific code and every information collected will be pseudonymised.
The group assignment will be hidden to the investigator and to the scientific collaborators who will collect, record and analyse the data. However, both patients and the two motivational interviewing counsellors will be aware of the group assignment.
|Official Title:||Motivational Interviewing to Increase Physical Activity Behaviour in Breast, Endometrial and Colorectal Cancer Patients in the Grand-Duchy of Luxembourg: a Pilot Randomized Controlled Trial|
|Actual Study Start Date :||July 6, 2017|
|Actual Primary Completion Date :||February 28, 2019|
|Actual Study Completion Date :||February 28, 2019|
Experimental: Motivational interviewing
Patients of the motivational interviewing group will receive standard care alongside motivational interviewing to change their behavior regarding physical activity.
Behavioral: Motivational interviewing
the patients of the motivational interviewing group will receive 12 motivational interviewing sessions within 12 weeks: 2 face-to-face sessions and 10 phone call sessions. The first and the seventh motivational interviewing sessions will be face-to-face sessions. An intervention is considered valid if a minimum of 10 sessions has been completed. The face-to-face motivational interviewing sessions will be administered at the Luxembourg Institute of Health (Strassen, Luxembourg). They generally last up to 30 minutes, while the motivational interviewing phone calls generally last up to 15 minutes. Thereby, patients in the motivational interviewing group will receive a total of approximately 3.5 hours of contact time over a period of 12 weeks.
Motivational interviewing techniques will explore self-assessed confidence, ambivalence, and personal values concerning changes in active lifestyle.
No Intervention: Control Group
Patients of the control group will receive standard care alone.
- Change in physical activity behavior [ Time Frame: week 1, week 14 and week 26 ]
An objective measurement of the patients' physical activity behaviour will be conducted using the ActiGraph™ GT3X+, a validated 3D-accelerometer, which will be used together with the corresponding ActiLife 6™ data analysis software. Physical activity behaviour will be measured three times (week 1, week 14 and week 26).
The main outcome is the change between week 1 and week 14.
- Body mass index [ Time Frame: week 1, week 14 and week 26 ]Body mass index will be calculated based on height and weight, combined to report BMI in kg/m^2. Height will be measured with a height gauge. Weight will be measured with a weighing machine.
- Ramped Bruce Protocol test [ Time Frame: week 1, week 14 and week 26 ]patients will start to walk at an initial speed set at 1.6 km/h on the treadmill on a horizontal position. Subsequently, the speed and the slope will be increased progressively according to the stages of a predefined protocol. The outcome will be the exercise stage reached at 85% of the maximal heart rate.
- 30 seconds chair test [ Time Frame: week 1, week 14 and week 26 ]Patients will rise to a full standing position and then sit back down again, repeating this movement for 30 seconds. The total number of repetitions will be recorded.
- Southampton protocol [ Time Frame: week 1, week 14 and week 26 ]The best of six grip strength measurements will be used in statistical analyses.
- Cost-effectiveness of the intervention [ Time Frame: week 1 (quality of life and cost questionnaires), week 4 (quality of life questionnaire), week 8 (quality of life questionnaire) week 14 (quality of life and cost questionnaires) and week 26 (quality of life and cost questionnaires) ]A decision analytic model will be developed to calculate the cost-effectiveness of motivational interviewing based on quality of life and cost questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210129
|Luxembourg Institute for Health|
|Luxembourg, Luxembourg, L-1460|
|Principal Investigator:||Laurent Malisoux, PhD||Luxembourg Institute of Health|
|Study Director:||Alexis Lion, PhD||Luxembourg Institute of Health|