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
Location: See all (8) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 d'un 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 control/usual 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 72
Healthy Volunteers: t
View:

• adult women who are between 18 and 72 years of age

• had a diagnosis of localized breast cancer of any type, and who have completed their treatment (surgery, chemotherapy, radiotherapy) within the last 15 months, or still undergoing hormone therapy or nearing the end of their Herceptin treatment.

• French-speaking

• covered by the French Social Security system or benefiting from a similar health insurance system

Locations
Other Locations
France
Angers
ACTIVE_NOT_RECRUITING
Angers
Arpajon
RECRUITING
Arpajon
Blagnac
RECRUITING
Blagnac
Brest
RECRUITING
Brest
La Roche sur Yon
RECRUITING
La Roche-sur-yon
La Rochelle
RECRUITING
La Rochelle
Saint Brieuc
RECRUITING
Saint-brieuc
Pyrénées Atlantiques
SUSPENDED
Saint-pée-sur-nivelle
Contact Information
Primary
Nicolas Deschamps
nicolas.deschamps@sielbleu.org
0033607129986
Backup
Gwenn Menvielle, PhD
Gwenn.menvielle@inserm.fr
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2027-01
Participants
Target number of participants: 160
Treatments
Experimental: ADA intervention
The ADA intervention arm
Active_comparator: Usual Care
The usual care arm
Related Therapeutic Areas
Sponsors
Leads: Siel Bleu
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov