Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer

NCT ID: NCT04665973

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2022-07-29

Brief Summary

Despite significant evolution of cancer therapies from the early 20th century, these therapies are still associated with toxic effects that negatively impact the patient's performance status, quality of life and survival. The role of physical activity to counteract these side effects is acknowledged. However, cancer patients are often misinformed about the potential benefits of physical therapy during cancer therapy. In this context, the role of therapeutic patient education seems essential.

Because of lack of time, therapeutic patient education (TPE) is often provided via an information booklet. However, the investigators assume that a face-to-face interview results in a greater impact on patient's behavior change (the level of physical activity during cancer therapy, in our case). This research project is designed to challenge this hypothesis. The investigators hypothesize that a brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the physical activity level of our patients for at least 6 months, i.e. during their cancer therapy.

Detailed Description

The investigators aim to compare the effects of two forms of TPE on the patient's PA level. In one of the two forms, TPE is delivered using an information booklet accompanied with a semi-structured oral interview (intervention group), whereas in the other form TPE is only delivered via the booklet (control group). The investigators hypothesize that the brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the PA level of our patients for at least 6 months, i.e. during their cancer therapy.

The study is designed as a double-blind randomized controlled trial. The primary outcome is the evolution in each group of the PA level (via the international physical activity questionnaire (IPAQ) - long form) between the start of cancer therapy and 6-month follow-up.

Eligible patients will be randomly assigned either to the intervention group (TPE includes the information booklet + the semi-structured oral intervention provided by a physiotherapist) or to the control group (TPE will consist only in the information booklet). Patients and assessors will be blinded.

The relative efficacy of these 2 treatment arms will be evaluated at baseline, after 3 months at a visit for a follow-up medical consultation set by the oncologist, and after 6 months at a second follow-up consultation.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Oral semi-structured interview

The oral semi-structured interview uses the principles of motivational interviewing (partnership with the patient, no judgment, altruism, evocation) and follow the content of the booklet used in the control group.

Group Type: EXPERIMENTAL

Therapeutic patient education : oral semi-structured interview

Intervention Type: BEHAVIORAL

The physiotherapist discusses and goes through each page of the booklet and involves the patient as much as possible. He demonstrates the exercises proposed in the booklet and then ask the patient to perform them in front of him. The physiotherapist tries to identify the patient's needs and suggests different ways to ensure that the patient has different opportunities to maintain the best possible level of PA

Booklet

The information booklet was designed by the physiotherapists at Cliniques universitaires Saint-Luc and is specifically dedicated to raise patient's awareness about the benefits of physical activity (PA) in the context of cancer.

Group Type: ACTIVE_COMPARATOR

Therapeutic patient education : booklet (passive)

Intervention Type: BEHAVIORAL

The booklet (11 pages): explains why it is important to maintain a good level of PA as part of cancer treatment and reviews the most common side effects of cancer therapy and the relative importance of PA in combating these effects (pages 2-3) ; defines PA, its modalities and possible security precautions (pages 4-5), suggests exercises to be performed oneself and a target intensity to be reached (pages 6-8), provides a roadmap to be completed oneself (pages 9-10), and outlines procedures for joining an exercise medicine group (page 11).

Interventions

Therapeutic patient education : oral semi-structured interview

The physiotherapist discusses and goes through each page of the booklet and involves the patient as much as possible. He demonstrates the exercises proposed in the booklet and then ask the patient to perform them in front of him. The physiotherapist tries to identify the patient's needs and suggests different ways to ensure that the patient has different opportunities to maintain the best possible level of PA

Intervention Type: BEHAVIORAL

Therapeutic patient education : booklet (passive)

The booklet (11 pages): explains why it is important to maintain a good level of PA as part of cancer treatment and reviews the most common side effects of cancer therapy and the relative importance of PA in combating these effects (pages 2-3) ; defines PA, its modalities and possible security precautions (pages 4-5), suggests exercises to be performed oneself and a target intensity to be reached (pages 6-8), provides a roadmap to be completed oneself (pages 9-10), and outlines procedures for joining an exercise medicine group (page 11).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults aged between 18 and 84 years
• Suffering from a first cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):

• non-melanoma skin cancer,
• carcinoma in situ of the uterine cervix
• ductal carcinoma in situ.
• Preserved performance status (ECOG scale ≤ 1),
• Starting one of the following systemic cancer therapies:

• chemotherapy,
• immunotherapy,
• targeted therapies,
• Able to understand and read French
• Life expectancy of at least 1 year

Exclusion Criteria

• Poor cognitive function (Mini-Mental State Examination ≤ 24/30)
• Having a recurrence of cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):

• non-melanoma skin cancer,
• carcinoma in situ of the uterine cervix,
• ductal carcinoma in situ.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

William Poncin, PT, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

ETAP

Identifier Type: -

Identifier Source: org_study_id