Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665973
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2020-12-07
Brief Title:
Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETAP
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 patients 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 patients 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 ie during their cancer therapy
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 patients 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 ie during their cancer therapy
Detailed Description:
The investigators aim to compare the effects of two forms of TPE on the patients 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None