Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients

NCT03210129 | Completed

• 1 other identifier: DoPH_SMRL_20161208
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer of Colon; Endometrial Cancer

Keywords

Motivation; Behavior; Exercise; Motivational interview; Cancer; economic evaluation

Outcome Measures

Primary Outcomes (1)

• 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.

  week 1, week 14 and week 26

Secondary Outcomes (5)

• Body mass index

  week 1, week 14 and week 26

• Ramped Bruce Protocol test

  week 1, week 14 and week 26

• 30 seconds chair test

  week 1, week 14 and week 26

• Southampton protocol

  week 1, week 14 and week 26

• Cost-effectiveness of the intervention

  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)

Study Arms (2)

Motivational interviewing

EXPERIMENTAL

Patients of the motivational interviewing group will receive standard care alongside motivational interviewing to change their behavior regarding physical activity.

Behavioral: Motivational interviewing

Control Group

NO INTERVENTION

Patients of the control group will receive standard care alone.

Interventions

Motivational interviewing BEHAVIORAL

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.

Motivational interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Fondation Cancer: collaborator

Study Sites (1)

Luxembourg Institute for Health

Luxembourg, L-1460, Luxembourg

Location

Related Links

• Official website of the Luxembourg Institute of Health
• Website of Sport-Santé which provides theoretical and practical information regarding exercise and health

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Endometrial Neoplasms; Behavior; Motor Activity; Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laurent Malisoux, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

• Alexis Lion, PhD

  Luxembourg Institute of Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: July 6, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)