Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05658341
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2022-12-02
Brief Title:
Program of Physical Activity Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors
Sponsor:
Siel Bleu
Organization:
Siel Bleu
Study Overview
Official Title:
Evaluating Effectiveness of an Integrative Intervention Based on Physical Activity Nutrition and Supportive Care to Improve Quality of Life of Breast Cancer Survivors Protocol for a Pragmatic Cluster Randomized Trial and Embedded Qualitative Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
ADA
Brief Summary:
Despite it being one of the leading causes of cancer death among women survival following a breast cancer diagnosis has greatly increased in high-income countries However this gave rise to a growing population of women living long after breast cancer with a diminished quality of life QoL due to the long-term effects of cancer and cancer treatment
Exercise can improve QoL fatigue and other mental and physical health outcomes in this population and is strongly recommended among breast cancer survivors much like a healthy diet However adherence in real-life to these recommendations is seldom satisfactory Also evidence regarding the effect and cost-effectiveness of concurrent healthy lifestyle behaviors compared to exercise alone is limited Hence the need to develop pragmatic evaluating the effectiveness of interventions in real-life conditions theoretical-based customized interventions which aim to improve uptake and instill long-term adherence of health lifestyle among breast cancer survivors
ADA Activité physique adaptée Doublée dun Accompagnement spécifique post-cancer is an integrative intervention based on physical activity nutrition and supportive care The interventions aims to improve breast cancer survivors physical and mental health and instill long-term healthy behaviors
Our study will be a pragmatic two-arm ADA intervention versus controlusual care cluster randomized controlled trial which examines the effectiveness of the ADA intervention program
The primary endpoint will be health-related quality of life as measured at 12-month after the start of the trial
Several secondary outcomes will also be assessed which include Physical activity level relationship to food and self-efficacy
The study aims to recruit 160 participants in total divided into 20 activity groups clusters of 8 participants
Primary analyses will be carried out on an intention to treat ITT basis at both cluster and participant level All statistical analysis will adjust for the clustering of patients within centers as a random effect
The aim of this trial is to provide scientific evidence on the real-world effectiveness of an easily generalizable trial with clinically-significant outcomes touching a growing number of cancer survivors
Exercise can improve QoL fatigue and other mental and physical health outcomes in this population and is strongly recommended among breast cancer survivors much like a healthy diet However adherence in real-life to these recommendations is seldom satisfactory Also evidence regarding the effect and cost-effectiveness of concurrent healthy lifestyle behaviors compared to exercise alone is limited Hence the need to develop pragmatic evaluating the effectiveness of interventions in real-life conditions theoretical-based customized interventions which aim to improve uptake and instill long-term adherence of health lifestyle among breast cancer survivors
ADA Activité physique adaptée Doublée dun Accompagnement spécifique post-cancer is an integrative intervention based on physical activity nutrition and supportive care The interventions aims to improve breast cancer survivors physical and mental health and instill long-term healthy behaviors
Our study will be a pragmatic two-arm ADA intervention versus controlusual care cluster randomized controlled trial which examines the effectiveness of the ADA intervention program
The primary endpoint will be health-related quality of life as measured at 12-month after the start of the trial
Several secondary outcomes will also be assessed which include Physical activity level relationship to food and self-efficacy
The study aims to recruit 160 participants in total divided into 20 activity groups clusters of 8 participants
Primary analyses will be carried out on an intention to treat ITT basis at both cluster and participant level All statistical analysis will adjust for the clustering of patients within centers as a random effect
The aim of this trial is to provide scientific evidence on the real-world effectiveness of an easily generalizable trial with clinically-significant outcomes touching a growing number of cancer survivors
Detailed Description:
None
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