Quality of LifeADANCT05658341
Program of Physical Activity, Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors
A study testing ADA in people with Quality of Life and Breast Cancer, run by Siel Bleu at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Breast Cancer
- What is being tested?
- ADA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 8 sitesFrance
- Study dates
- 6 Nov 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gwenn Menvielle, PhD contact
8 sites in 1 country
France8 sites, 6 recruiting
- Active, not recruiting
Angers
Angers, Maine Et Loire, 49
- Recruiting
Arpajon
Arpajon, Essonne, 91
Florine FAYE, 00336 61 43 38 83, florine.faye@sielbleu.org
- Recruiting
Blagnac
Blagnac, Haute Garonne, 31
Noëllie DELAVERNHE, 00337 63 87 73 52, noellie.delavernhe@sielbleu.org
- Recruiting
Brest
Brest, Finistere, 29
Doriane MICAT, 0033607129986, doriane.micat@sielbleu.org
- Recruiting
La Roche sur Yon
La Roche-sur-Yon, Vendée, 85
Margot MIOT, 0033668029399, margot.miot@sielbleu.org
- Recruiting
La Rochelle
La Rochelle, Charentes-maritimes, 17
Clarisse Roux, 00337 50 57 56 62, clarisse.roux@sielbleu.org
- Recruiting
Saint Brieuc
Saint-Brieuc, Cotes d'Armor, 22
Elsa MARTINS, 0033669757702, elsa.martins@sielbleu.org
- Suspended
Pyrénées Atlantiques
Saint-Pée-sur-Nivelle, Pyrénées Atlantiques, 64
About this study
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
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.
Read more
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
- Being tested
- ADA, Usual Care
- Keywords
- Adapted physical activity, Breast cancer survivors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADABehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ADA intervention | Experimental | The ADA intervention arm Receives: Behavioral: ADA |
| Usual Care | Active comparator | The usual care arm Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the beginning of the intervention
Secondary outcomes (7)
Physical, social, emotional, and functional well-being
measured separately by the FACT-G four different subscales. Higher score indicate better Quality of life.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 3 months, 6 months, and 12 months after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Nov 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siel Bleu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenn Menvielle, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FrancePatricia Dargent, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FranceFabienne El Khoury, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658341
- Sponsor's protocol ID
- ADA
- Acronym
- ADA
- Status last verified
- Jul 2025
- First submitted
- 2 Dec 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38485475
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05658341
- Acronym / sponsor ID
- ADA / ADA
- Conditions
- Quality of Life, Breast Cancer
- Keywords
- Adapted physical activity, Breast cancer survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Siel BleuUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| ADA intervention | Experimental | Behavioral: ADAThe ADA intervention arm |
| Usual Care | Active comparator | Behavioral: Usual CareThe usual care arm |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAThe 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. | Behavioural | ADA intervention |
| Usual CareParticipants 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. | Behavioural | Usual Care |
Primary outcome
Health-related quality of life
Time frame: 12 months after the beginning of the intervention
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.
7 secondary outcomes
Physical, social, emotional, and functional well-being
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Fatigue
Time frame: At 3 months, and 6 months after the beginning of the intervention
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
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Sedentary behavior (sitting time)
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Relationship to food
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Self-efficacy
Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 38485475El-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwenn Menvielle, PhD contact
Gwenn Menvielle, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Patricia Dargent, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Fabienne El Khoury, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADA in people with Quality of Life and Breast Cancer, run by Siel Bleu at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Deschamps (0033607129986, nicolas.deschamps@sielbleu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 12 months after the beginning of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.