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

NCT04665973 | Completed

• 1 other identifier: ETAP
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Therapeutic Patient Education; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Changes in PA level

  The PA level will be estimated in MET/h/week via the International Physical Activity Questionnaire (long form) validated in French in subjects aged 18-84 years. The questionnaire classifies the subject according to 3 activity levels: inactive, moderate, high

  At baseline and 6 months (at the occasion of a second follow-up visit set with the oncologist) after the start of the cancer therapy

Secondary Outcomes (8)

• Changes in PA level

  At baseline and 3 months (at the occasion of a first follow-up visit set with the oncologist) after the start of the cancer therapy

• Changes in BMI

  At baseline, 3 months and 6 months after the start of the cancer therapy

• Changes in fatigue

  At baseline, 3 months and 6 months after the start of the cancer therapy

• Changes in quality of life

  At baseline, 3 months and 6 months after the start of the cancer therapy

• Changes in exercise capacity

  At baseline, 3 months and 6 months after the start of the cancer therapy

Study Arms (2)

Oral semi-structured interview

EXPERIMENTAL

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.

Behavioral: Therapeutic patient education : oral semi-structured interview

Booklet

ACTIVE COMPARATOR

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.

Behavioral: Therapeutic patient education : booklet (passive)

Interventions

Therapeutic patient education : oral semi-structured interview 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

Oral semi-structured interview

Therapeutic patient education : booklet (passive) 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).

Booklet

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 7, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

BE (1)