Cancer Related FatigueAQUA-POLONCT04235946
Feasibility Study of an Adapted and Supported Water Polo Program to Reduce Fatigue Related to Cancer and Improve Psychological and Social Recovery in Patients With Breast Cancer Remission
A study testing accompanied and adapted water polo program in people with Cancer Related Fatigue and Breast Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Related Fatigue, Breast Cancer
- What is being tested?
- accompanied and adapted water polo program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman aged 18 to 65, with a good understanding and good practice of the French language.
- Having been diagnosed with breast cancer: any type of cancer, any type of treatment. Inclusion from 3 weeks to 3 months after the end of treatment (excluding hormone therapy and immunotherapy) Patients who have undergone surgery may be included from 6 weeks post-operative.
- Signed consent to participate.
- Affiliation to a social security scheme or beneficiary of such a scheme.
- Live within a maximum radius of 40 km around Marseille.
- Swimming skills (basic level).
Who cannot join
- Being undergoing chemotherapy treatment
- Unacquired healing
- Metastatic cancers
- Proven psychological pathology proven according to diagnostic criteria (DSM-V)
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed).
Read the detailed description
Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.
- Conditions
- Cancer Related Fatigue, Breast Cancer
- Being tested
- accompanied and adapted water polo program
- Keywords
- cancer related fatigue, adapted physical activity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accompanied and adapted water polo programOther
Validated questionnaires in French will measure fatigue, quality of life, post-traumatic growth and the coach-athlete relationship. All questionnaires will be administered face to face before the sessions by a member of the social psychology research team.
The collection of qualitative data (semi-structured interviews) will be carried out by one of the members of the research team in social psychology on three occasions (inclusion, Week 10 and Week 20) in order to assess the psychological variables of interest (quality interpersonal relationships, self-esteem, post-traumatic growth) and their dynamics.
Physiological variables (weight, fat / lean mass, capacity of the operated arm) will be evaluated monthly. The physical measurement data will be recorded in an electronic case report form
| Study group | Role | What they receive |
|---|---|---|
| accompanied and adapted water polo program | Experimental | 16 and 20 aqua polo sessions (adapted water polo) over a period of 20 weeks, at the rate of one session per week at the Cercle des Nageurs de Marseille (CNM). They will be divided into 3 cycles imitating the preparation of the season of a high-level athlete: a first cycle intended for physical preparation, a second cycle intended for practical learning (technique and tactics) and the third cycle for preparation of a mini tournament.
Each session will be organized as follows: 1 hour of training in the water followed by 30 min of "debriefing" as a team or individually with the coach. The announced duration of the session will be 2 hours, transport and changing rooms included. Receives: Other: accompanied and adapted water polo program |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of maintenance of a high level of adherence to the program of physical activities
the percentage of patients performing 60% of the scheduled sessions. The proposal to participate in this program will be made by the surgeon, oncologist or radiotherapist.
Measured: 20 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Mar 2021 (estimated)
- Primary completion15 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer Related FatigueStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Management Sport Cancer EA 4670
- Responsible party
- Sponsor
- Investigators
- Monique COHEN, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235946
- Sponsor's protocol ID
- Aqua POLO-IPC 2019-028
- Other IDs
- 2019-A03003-54
- Acronym
- AQUA-POLO
- Status last verified
- Aug 2020
- First submitted
- 17 Jan 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuvelier S, Goetgheluck-Villaron C, Zemmour C, Bernasconi S, Tallet A, Arthur A, Dantin P, Viens P, Cohen M, Calvin S. Exploring adapted water polo: a feasibility study on improving psychosocial recovery in women post-breast cancer treatment. Front Sports Act Living. 2026 Sep 30;8:1910555. doi: 10.3389/fspor.2026.1910555. eCollection 2026.
PubMed 42876842Cuvelier S, Goetgheluck-Villaron C, Cohen M, Tallet A, Berline M, Boher JM, Jowett S, Justafre S, Dantin P, Viens P, Calvin S. Aqua polo: Preliminary feasibility and efficacy study of a programme of adapted, supervised water polo to reduce fatigue and improve women's psychological and social recovery after breast cancer treatment: A mixed-methods design. Contemp Clin Trials Commun. 2023 Mar 22;33:101120. doi: 10.1016/j.conctc.2023.101120. eCollection 2023 Jun.
PubMed 37026030
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Adapted and Supported Water Polo Program to Reduce Fatigue Related to Cancer and Improve Psychological and Social Recovery in Patients With Breast Cancer Remission
- ClinicalTrials.gov ID
- NCT04235946
- Acronym / sponsor ID
- AQUA-POLO / Aqua POLO-IPC 2019-028
- Conditions
- Cancer Related Fatigue, Breast Cancer
- Keywords
- cancer related fatigue, adapted physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Laboratoire Management Sport Cancer EA 4670
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Jan 2020 (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.
The main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed).
Detailed description
Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.
| Arm | Type | Receives |
|---|---|---|
| accompanied and adapted water polo program | Experimental | Other: accompanied and adapted water polo program16 and 20 aqua polo sessions (adapted water polo) over a period of 20 weeks, at the rate of one session per week at the Cercle des Nageurs de Marseille (CNM). They will be divided into 3 cycles imitating the preparation of the season of a high-level athlete: a first cycle intended for physical preparation, a second cycle intended for practical learning (technique and tactics) and the third cycle for preparation of a mini tournament. Each session will be organized as follows: 1 hour of training in the water followed by 30 min of "debriefing" as a team or individually with the coach. The announced duration of the session will be 2 hours, transport and changing rooms included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman aged 18 to 65, with a good understanding and good practice of the French language.
- Having been diagnosed with breast cancer: any type of cancer, any type of treatment. Inclusion from 3 weeks to 3 months after the end of treatment (excluding hormone therapy and immunotherapy) Patients who have undergone surgery may be included from 6 weeks post-operative.
- Signed consent to participate.
- Affiliation to a social security scheme or beneficiary of such a scheme.
- Live within a maximum radius of 40 km around Marseille.
Key exclusion criteria (5 listed)
- Being undergoing chemotherapy treatment
- Unacquired healing
- Metastatic cancers
- Proven psychological pathology proven according to diagnostic criteria (DSM-V)
- Pregnant or lactating woman
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 |
|---|---|---|
| accompanied and adapted water polo programValidated questionnaires in French will measure fatigue, quality of life, post-traumatic growth and the coach-athlete relationship. All questionnaires will be administered face to face before the sessions by a member of the social psychology research team. The collection of qualitative data (semi-structured interviews) will be carried out by one of the members of the research team in social psychology on three occasions (inclusion, Week 10 and Week 20) in order to assess the psychological variables of interest (quality interpersonal relationships, self-esteem, post-traumatic growth) and their dynamics. Physiological variables (weight, fat / lean mass, capacity of the operated arm) will be evaluated monthly. The physical measurement data will be recorded in an electronic case report form | Other | accompanied and adapted water polo program |
Primary outcome
rate of maintenance of a high level of adherence to the program of physical activities
Time frame: 20 WEEKS
the percentage of patients performing 60% of the scheduled sessions. The proposal to participate in this program will be made by the surgeon, oncologist or radiotherapist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 42876842Cuvelier S, Goetgheluck-Villaron C, Zemmour C, Bernasconi S, Tallet A, Arthur A, Dantin P, Viens P, Cohen M, Calvin S. Exploring adapted water polo: a feasibility study on improving psychosocial recovery in women post-breast cancer treatment. Front Sports Act Living. 2026 Sep 30;8:1910555. doi: 10.3389/fspor.2026.1910555. eCollection 2026.
- Derived from this study: PubMed 37026030Cuvelier S, Goetgheluck-Villaron C, Cohen M, Tallet A, Berline M, Boher JM, Jowett S, Justafre S, Dantin P, Viens P, Calvin S. Aqua polo: Preliminary feasibility and efficacy study of a programme of adapted, supervised water polo to reduce fatigue and improve women's psychological and social recovery after breast cancer treatment: A mixed-methods design. Contemp Clin Trials Commun. 2023 Mar 22;33:101120. doi: 10.1016/j.conctc.2023.101120. eCollection 2023 Jun.
- 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. This study is not recruiting at the moment.
Monique COHEN, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accompanied and adapted water polo program in people with Cancer Related Fatigue and Breast Cancer, run by Institut Paoli-Calmettes at 1 site 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (33491223778, DRCI.UP@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of maintenance of a high level of adherence to the program of physical activities (time frame: 20 WEEKS). 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 NCT04235946, which also lists 2 linked publications.
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 19 Aug 2020.