Cancer, BreastMIPACluxNCT03210129
Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients
A study testing Motivational interviewing in people with Cancer, Breast and Cancer of Colon, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Cancer of Colon, Endometrial Cancer
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteLuxembourg
- Study dates
- 6 Jul 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
All recruited patients will receive the same standard care, only those who will be allocated to the experimental group will receive the intervention. This project will run over total period of 21 months. Patients will be offered to join the project over a duration of 12 months. With the help of oncologists and surgeons, an oral agreement will be collected from the eligible patients who agree to be contacted by an investigator of the study. Once the patients have entered the study, they will be followed for 26 weeks, including 12 weeks of intervention or control period and 12 weeks of follow-up to evaluate if the expected intervention-induced behavioural change is maintained:
- Week 1: inclusion and first visit. The patients will be contacted (phone call) by an investigator who will provide explanations about the study. Notably, the investigator will explain that the patients will be allocated randomly to one of two study arms and that they may not chose which one they will be allocated to. In addition, the investigator will check eligibility through a brief questionnaire-based interview. Patients who meet the inclusion criteria will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg) for the first visit. During this first visit (duration: 90 min), patients will be asked to sign the written informed consent. Then, patients will be asked to fill in several questionnaires available in English, French, German and Portuguese: three background questionnaires and one cancer-specific health related quality of life (HRQoL) questionnaire (EORTC-QLQ30). Height and weight will be measured. Patients will subsequently perform physical fitness tests, including ramped Bruce protocol test on a treadmill, leg strength and grip strength tests. Finally, patients will receive a 3D-accelerometer (Actigraph) measuring physical activity behaviour, which they will have to wear for one week. Further details one these methodologies are provided below.
- End of week 1: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer. Furthermore, patients will reply by telephone to the generic HRQoL questionnaire (EQ-5D-5L questionnaire, please see details of this questionnaire in the "Cost-effectiveness of the intervention" section). This questionnaire will be administered repetitively throughout and at the end of the intervention.
- Week 2 to week 13: intervention. During a period of 12 weeks, the patients in the intervention group will attend 2 face-to-face and 10 telephone motivation interviewing sessions (please see details in the "Intervention" section). The patients entering the control group will not receive this specific treatment during that period.
- Week 5: phone call. The patients will be called to answer the EQ-5D-5L questionnaire.
- Week 9: phone call. The patients will be called to answer the EQ-5D-5L questionnaire.
- Week 13: phone call. Patients will be called for a reminder of the second visit date (already determined during the first visit).
- Week 14: second visit. Patients will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg). During this second visit (duration: 70 min), patient will fill in the EORTC-QLQ30 questionnaire and the cost questionnaire (please see details of this questionnaire in the "Cost-effectiveness of the intervention" section). Height and weight will be measured. Patients will perform the same physical fitness tests as during the first visit (ramped Bruce protocol on a treadmill, leg strength and grip strength). Patients will be handed out the accelerometer to be worn during one week to evaluate their physical activity behaviour.
- End of week 14: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer and to answer the EQ-5D-5L questionnaire.
- Week 14 to week 25: follow-up.
- Week 25: Phone call. Patients will be called for a reminder of the third visit date (already determined during the second visit).
- Week 26: third visit. Patients will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg). During this third visit (duration: 70 min), patient will fill in the EORTC-QLQ30 questionnaire and the cost questionnaire. Height and weight will be measured. Patients will perform the same physical fitness tests as during the first and second visits (ramped Bruce protocol on a treadmill, leg strength and grip strength). Patients will be handed out the accelerometer to be worn during one week to evaluate their physical activity behaviour.
- End of week 26: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer and to answer the EQ-5D-5L questionnaire.
- Conditions
- Cancer, Breast, Cancer of Colon, Endometrial Cancer
- Being tested
- Motivational interviewing
- Keywords
- Motivation, Behavior, Exercise, Motivational interview, Cancer, economic evaluation
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Endometrial Neoplasms, Behavior, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Patients of the motivational interviewing group will receive standard care alongside motivational interviewing to change their behavior regarding physical activity. Receives: Behavioral: Motivational interviewing |
| Control Group | No intervention | Patients of the control group will receive standard care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity behavior
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.
Measured: week 1, week 14 and week 26
Secondary outcomes (5)
Body mass index
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.
Measured: week 1, week 14 and week 26
Ramped Bruce Protocol test
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.
Measured: week 1, week 14 and week 26
30 seconds chair test
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.
Measured: week 1, week 14 and week 26
Southampton protocol
The best of six grip strength measurements will be used in statistical analyses.
Measured: week 1, week 14 and week 26
Cost-effectiveness of the intervention
A decision analytic model will be developed to calculate the cost-effectiveness of motivational interviewing based on quality of life and cost questionnaires.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start6 Jul 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Fondation Cancer
- Responsible party
- Principal investigator, Laurent Malisoux, PhD, Luxembourg Institute of Health
- Investigators
- Laurent Malisoux, PhD, Principal investigator, Luxembourg Institute of HealthAlexis Lion, PhD, Study director, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210129
- Sponsor's protocol ID
- DoPH_SMRL_20161208
- Acronym
- MIPAClux
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03210129
- Acronym / sponsor ID
- MIPAClux / DoPH_SMRL_20161208
- Conditions
- Cancer, Breast, Cancer of Colon, Endometrial Cancer
- Keywords
- Motivation, Behavior, Exercise, Motivational interview, Cancer, economic evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Fondation Cancer
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All recruited patients will receive the same standard care, only those who will be allocated to the experimental group will receive the intervention. This project will run over total period of 21 months. Patients will be offered to join the project over a duration of 12 months. With the help of oncologists and surgeons, an oral agreement will be collected from the eligible patients who agree to be contacted by an investigator of the study. Once the patients have entered the study, they will be followed for 26 weeks, including 12 weeks of intervention or control period and 12 weeks of follow-up to evaluate if the expected intervention-induced behavioural change is maintained:
- Week 1: inclusion and first visit. The patients will be contacted (phone call) by an investigator who will provide explanations about the study. Notably, the investigator will explain that the patients will be allocated randomly to one of two study arms and that they may not chose which one they will be allocated to. In addition, the investigator will check eligibility through a brief questionnaire-based interview. Patients who meet the inclusion criteria will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg) for the first visit. During this first visit (duration: 90 min), patients will be asked to sign the written informed consent. Then, patients will be asked to fill in several questionnaires available in English, French, German and Portuguese: three background questionnaires and one cancer-specific health related quality of life (HRQoL) questionnaire (EORTC-QLQ30). Height and weight will be measured. Patients will subsequently perform physical fitness tests, including ramped Bruce protocol test on a treadmill, leg strength and grip strength tests. Finally, patients will receive a 3D-accelerometer (Actigraph) measuring physical activity behaviour, which they will have to wear for one week. Further details one these methodologies are provided below.
- End of week 1: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer. Furthermore, patients will reply by telephone to the generic HRQoL questionnaire (EQ-5D-5L questionnaire, please see details of this questionnaire in the "Cost-effectiveness of the intervention" section). This questionnaire will be administered repetitively throughout and at the end of the intervention.
- Week 2 to week 13: intervention. During a period of 12 weeks, the patients in the intervention group will attend 2 face-to-face and 10 telephone motivation interviewing sessions (please see details in the "Intervention" section). The patients entering the control group will not receive this specific treatment during that period.
- Week 5: phone call. The patients will be called to answer the EQ-5D-5L questionnaire.
- Week 9: phone call. The patients will be called to answer the EQ-5D-5L questionnaire.
- Week 13: phone call. Patients will be called for a reminder of the second visit date (already determined during the first visit).
- Week 14: second visit. Patients will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg). During this second visit (duration: 70 min), patient will fill in the EORTC-QLQ30 questionnaire and the cost questionnaire (please see details of this questionnaire in the "Cost-effectiveness of the intervention" section). Height and weight will be measured. Patients will perform the same physical fitness tests as during the first visit (ramped Bruce protocol on a treadmill, leg strength and grip strength). Patients will be handed out the accelerometer to be worn during one week to evaluate their physical activity behaviour.
- End of week 14: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer and to answer the EQ-5D-5L questionnaire.
- Week 14 to week 25: follow-up.
- Week 25: Phone call. Patients will be called for a reminder of the third visit date (already determined during the second visit).
- Week 26: third visit. Patients will be invited to come to the Luxembourg Institute of Health (Strassen, Luxembourg). During this third visit (duration: 70 min), patient will fill in the EORTC-QLQ30 questionnaire and the cost questionnaire. Height and weight will be measured. Patients will perform the same physical fitness tests as during the first and second visits (ramped Bruce protocol on a treadmill, leg strength and grip strength). Patients will be handed out the accelerometer to be worn during one week to evaluate their physical activity behaviour.
- End of week 26: phone call. An investigator will call the patients one day before the end of the recording period of physical activity to remind them to send back the accelerometer and to answer the EQ-5D-5L questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational interviewingPatients of the motivational interviewing group will receive standard care alongside motivational interviewing to change their behavior regarding physical activity. |
| Control Group | No intervention | –Patients of the control group will receive standard care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- breast, endometrial or colorectal cancer
- cancer stage ≤ stage III
- > 3 months after primary treatment
- < 24 months after primary treatment
- ECOG performance score < 2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingthe 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. | Behavioural | Motivational interviewing |
Primary outcome
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.
5 secondary outcomes
Body mass index
Time frame: week 1, week 14 and week 26
Ramped Bruce Protocol test
Time frame: week 1, week 14 and week 26
30 seconds chair test
Time frame: week 1, week 14 and week 26
Southampton protocol
Time frame: week 1, week 14 and week 26
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Official website of the Luxembourg Institute of HealthLink provided by the sponsor.
- Website of Sport-Santé which provides theoretical and practical information regarding exercise and healthLink provided by the sponsor.
- Individual participant dataSharing planned: No. The IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Malisoux, PhD principal investigator
Luxembourg Institute of Health
Alexis Lion, PhD study director
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Cancer, Breast and Cancer of Colon, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity behavior (time frame: week 1, week 14 and week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.