Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients (MIPAClux)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210129
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Fondation Cancer
Information provided by (Responsible Party):
Laurent Malisoux, PhD, Luxembourg Institute of Health

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
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)
Masking Description:

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.

Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Southampton protocol [ Time Frame: week 1, week 14 and week 26 ]
    The best of six grip strength measurements will be used in statistical analyses.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast, endometrial or colorectal cancer
  • cancer stage ≤ stage III
  • > 3 months after primary treatment
  • < 24 months after primary treatment
  • ECOG performance score < 2
  • Signed Informed consent

Exclusion Criteria:

  • recurrent cancer
  • history of other types of cancer
  • second primary tumor
  • planned surgery within the duration of the study
  • known or obvious cognitive or psychiatric impairments
  • positive pregnancy test

Information from the National Library of Medicine

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


Locations
Layout table for location information
Luxembourg
Luxembourg Institute for Health
Luxembourg, Luxembourg, L-1460
Sponsors and Collaborators
Luxembourg Institute of Health
Fondation Cancer
Investigators
Layout table for investigator information
Principal Investigator: Laurent Malisoux, PhD Luxembourg Institute of Health
Study Director: Alexis Lion, PhD Luxembourg Institute of Health
Additional Information:
Layout table for additonal information
Responsible Party: Laurent Malisoux, PhD, PhD, Luxembourg Institute of Health
ClinicalTrials.gov Identifier: NCT03210129    
Other Study ID Numbers: DoPH_SMRL_20161208
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD will not be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurent Malisoux, PhD, Luxembourg Institute of Health:
Motivation
Behavior
Exercise
Motivational interview
Cancer
economic evaluation
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Breast Neoplasms
Colonic Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases