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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
160
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.
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.
La Rochelle
La Rochelle, Charentes-maritimes, France
RECRUITINGSaint Brieuc
Saint-Brieuc, Cotes d'Armor, France
RECRUITINGArpajon
Arpajon, Essonne, France
RECRUITINGBrest
Brest, Finistere, France
RECRUITINGBlagnac
Blagnac, Haute Garonne, France
RECRUITINGAngers
Angers, Maine Et Loire, France
ACTIVE_NOT_RECRUITINGPyrénées Atlantiques
Saint-Pée-sur-Nivelle, Pyrénées Atlantiques, France
SUSPENDEDLa Roche sur Yon
La Roche-sur-Yon, Vendée, France
RECRUITINGHealth-related quality of life
The primary endpoint will be the health-related quality of life, as measured by the FACIT-F global score. This score is based on the 27-items Functional Assessment of Cancer Therapy-General (FACT-G) scale ,and the 13-items fatigue subscale included in the FACIT-F. Higher score indicate better Quality of life.
Time frame: 12 months after the beginning of the intervention
Physical, social, emotional, and functional well-being
measured separately by the FACT-G four different subscales. Higher score indicate better Quality of life.
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Fatigue
measured by the FACIT-F global score. This score is based on the 13-items fatigue subscale included in the FACIT-F.
Time frame: At 3 months, and 6 months after the beginning of the intervention
Physical activity level
Measured with the short version of the International Physical Activity Questionnaire (IPAQ-SF).A higher IPAQ-SF score indicates a better physical activity level..
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Motivation for physical activity Questionnaire-2 (BREQ-2) scale
assessed with the short form of Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2). A higher BREQ-2 score indicates a better exercise motivation.
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Sedentary behavior (sitting time)
measured with a questionnaire adapted from the Recent Physical Activity Questionnaire (RPAQ). A higher RPAQ score indicates a lower sedentary behavior level.
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Relationship to food
Measured using a scale adapted from the Positive Eating Scale. A Higher score indicates a positive relationship with eating.
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Self-efficacy
people's beliefs about their ability to produce designated levels of performance that influence events that affect their lives, assessed by an ad-hoc scale
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.