Program of Physical Activity, Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors

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.

Conditions

• Quality of Life
• Breast Cancer

Interventions

BEHAVIORAL

ADA

The 12-weeks program will include one-hour in adapted physical activity (APA), and a discussion on relaxation techniques and the undertaking of deep breathing exercises (making them APA+ sessions). A series of "minute for nutrition" short information sheets will be distributed at the end of each session. Two workshops on "living better after breast cancer" will also be offered: one on general mobility and the other on daily nutrition. Moreover, women will be asked to set personal challenges as a method of motivational reinforcement, and will also be called for motivational check-ins at least 3 times. Follow-up calls will allow for further individualization, motivation, and the reception of participants' concerns or remarks. Further, participants in the intervention group will have access to a dedicated internet space containing several documents and videos on topics of concern to patients during the post-treatment phase.

BEHAVIORAL

Usual Care

Participants in the control group will be offered weekly APA sessions for 12 weeks, these sessions are based on current practices within the Siel Bleu organization. Sessions' content is adapted to people who have been treated for (all types) cancer and are based on current recommendations. These sessions are commonly organized by Siel Bleu in hospitals, community groups or local committees of the national league against cancer organization.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Siel Bleu

  lead OTHER

Principal Investigators

• Gwenn Menvielle, PhD · Institut National de la Santé Et de la Recherche Médicale, France

• Patricia Dargent, PhD · Institut National de la Santé Et de la Recherche Médicale, France

• Fabienne El Khoury, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

72 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-06

Primary Completion

2026-01-31

Completion

2027-01-31

Countries

• France

Study Locations