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

NCT05658341 | Recruiting

• 1 other identifier: ADA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

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 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

Keywords

Adapted physical activity; Breast cancer survivors

Outcome Measures

Primary Outcomes (1)

• Health-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.

  12 months after the beginning of the intervention

Secondary Outcomes (7)

• Physical, social, emotional, and functional well-being

  At 3 months, 6 months, and 12 months after the beginning of the intervention

• Fatigue

  At 3 months, and 6 months after the beginning of the intervention

• Physical activity level

  At 3 months, 6 months, and 12 months after the beginning of the intervention

• Motivation for physical activity Questionnaire-2 (BREQ-2) scale

  At 3 months, 6 months, and 12 months after the beginning of the intervention

• Sedentary behavior (sitting time)

  At 3 months, 6 months, and 12 months after the beginning of the intervention

Study Arms (2)

ADA intervention

EXPERIMENTAL

The ADA intervention arm

Behavioral: ADA

Usual Care

ACTIVE COMPARATOR

The usual care arm

Behavioral: Usual Care

Interventions

ADA BEHAVIORAL

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.

ADA intervention

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A cancer diagnosis other than breast cancer, or a relapse/metastasis of breast cancer, or generalized cancer,
• A medical contraindication to exercise (a medical certificate of absence of contraindication to the practice of physical activity will be required, as for all physical activity in community settings).
• Significant visual or auditory problems or behavioral problems that make it difficult to participate in group physical activity sessions.
• a plan of moving away from the study site.
• participating in another clinical trial
• Male sex

Sponsors & Collaborators

• Siel Bleu: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (8)

La Rochelle

La Rochelle, Charentes-maritimes, 17, France

RECRUITING

Saint Brieuc

Saint-Brieuc, Cotes d'Armor, 22, France

RECRUITING

Arpajon

Arpajon, Essonne, 91, France

RECRUITING

Brest

Brest, Finistere, 29, France

RECRUITING

Blagnac

Blagnac, Haute Garonne, 31, France

RECRUITING

Angers

Angers, Maine Et Loire, 49, France

ACTIVE NOT RECRUITING

Pyrénées Atlantiques

Saint-Pée-sur-Nivelle, Pyrénées Atlantiques, 64, France

SUSPENDED

La Roche sur Yon

La Roche-sur-Yon, Vendée, 85, France

RECRUITING

Related Publications (1)

• El-Khoury F, Mino JC, Deschamps N, Lopez C, Menvielle G, Dargent-Molina P. Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study. BMJ Open. 2024 Mar 14;14(3):e081447. doi: 10.1136/bmjopen-2023-081447.

  PMID: 38485475 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gwenn Menvielle, PhD

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

  PRINCIPAL INVESTIGATOR

• Patricia Dargent, PhD

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

  PRINCIPAL INVESTIGATOR

• Fabienne El Khoury, PhD

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

  STUDY CHAIR

Central Study Contacts

Nicolas Deschamps

CONTACT

0033607129986; nicolas.deschamps@sielbleu.org

Gwenn Menvielle, PhD

CONTACT

Gwenn.menvielle@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 20, 2022
• Study Start: November 6, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)