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

Cancer Clinical Trial

— ETAP  

Official title:

Effect of a Brief Therapeutic Patient Education Session on Physical Activity in Patients at the Onset of Cancer Therapy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665973
• Other study ID #: ETAP
• Status: Completed
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: July 29, 2022

Study information

• Verified date: April 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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
• 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).

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 3 months (at the occasion of a first follow-up visit set with the oncologist) after the start of the cancer therapy
Secondary	Changes in BMI	Body mass index (BMI) is measured as weight (kg) divided by height is meters squared (m²)	At baseline, 3 months and 6 months after the start of the cancer therapy
Secondary	Changes in fatigue	Fatigue is measured via the Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F).; The scale is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function.; The total score range from 0 to 160. The lower the score, the higher the fatigue.	At baseline, 3 months and 6 months after the start of the cancer therapy
Secondary	Changes in quality of life	Quality of life is measured via the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30).; The QLQ-C30 is composed of both multi-item scales and single-item measures. There are 30 items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All single-item measures range in score from 0 to 100.; A high score for a functional scale represents a high / healthy level of functioning, A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems.	At baseline, 3 months and 6 months after the start of the cancer therapy
Secondary	Changes in exercise capacity	Exercise capacity is measured via the 1-minute sit-to-stand test	At baseline, 3 months and 6 months after the start of the cancer therapy
Secondary	Changes in handgrip strength test	Handgrip strength test is measured via the JAMAR dynamometer	At baseline, 3 months and 6 months after the start of the cancer therapy
Secondary	Number of steps	The number of steps taken weekly via an application (ITO) downloaded on the patient's phone	At 3 months and 6 months after the start of the cancer therapy
Secondary	Number of patients entering a group of exercise medicine	The proportion of patient who started a program of exercise medicine will be calculated in each group	At 6 months after the start of the cancer therapy