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 (AQUA-POLO)

August 18, 2020 updated by: Institut Paoli-Calmettes
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Cercle des nageurs de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

Laboratoire Management Sport Cancer EA 4670

Investigators

  • Principal Investigator: Monique COHEN, MD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

December 15, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aqua POLO-IPC 2019-028
  • 2019-A03003-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on accompanied and adapted water polo program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe