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Status unknownNCT04235946AQUA-POLOUpdated Aug 19, 2020

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

An interventional study of accompanied and adapted water polo program in Cancer Related Fatigue and Breast Cancer, sponsored by Institut Paoli-Calmettes. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-19.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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 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.

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Conditions studied

  • Cancer Related Fatigue
  • Breast Cancer

Keywords

  • cancer related fatigue
  • adapted physical activity
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 24 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Woman aged 18 to 65, with a good understanding and good practice of the French language.
  2. 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.
  3. Signed consent to participate.
  4. Affiliation to a social security scheme or beneficiary of such a scheme.
  5. Live within a maximum radius of 40 km around Marseille.
  6. Swimming skills (basic level).

Exclusion criteria

Exclusion Criteria:

  1. Being undergoing chemotherapy treatment
  2. Unacquired healing
  3. Metastatic cancers
  4. Proven psychological pathology proven according to diagnostic criteria (DSM-V)
  5. Pregnant or lactating woman
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    accompanied and adapted water polo program

    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.

    Other: accompanied and adapted water polo program

Interventions

  • Otheraccompanied and adapted water polo program

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20 WEEKS

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Study locations

1 site
  • Cercle des nageurs de Marseille
    Marseille, France
    • Sarah CALVIN · Contact
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04235946
Lead sponsor
Institut Paoli-Calmettes
Collaborators
Laboratoire Management Sport Cancer EA 4670
Responsible party
Sponsor
First posted
Jan 22, 2020
Start date
Mar 15, 2021 (estimated)
Primary completion
Dec 15, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Aug 19, 2020

Study contacts

Dominique GENRE, MD
Contact
DRCI.UP@ipc.unicancer.fr
33491223778
Margot Berline, MSC, MBA
Contact
BERLINEM@ipc.unicancer.fr
33491223778
Monique COHEN, MD
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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