Clinical trial NCT04665973: Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Therapeutic Patient Education
Physical Activity
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Changes in PA level
timeFrame: 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:
measure: Changes in PA level
timeFrame: 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
measure: Changes in BMI
timeFrame: At baseline, 3 months and 6 months after the start of the cancer therapy
measure: Changes in fatigue
timeFrame: At baseline, 3 months and 6 months after the start of the cancer therapy
measure: Changes in quality of life
timeFrame: At baseline, 3 months and 6 months after the start of the cancer therapy
measure: Changes in exercise capacity
timeFrame: At baseline, 3 months and 6 months after the start of the cancer therapy
measure: Changes in handgrip strength test
timeFrame: At baseline, 3 months and 6 months after the start of the cancer therapy
measure: Number of steps
timeFrame: At 3 months and 6 months after the start of the cancer therapy
measure: Number of patients entering a group of exercise medicine
timeFrame: At 6 months after the start of the cancer therapy
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References: