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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)

Primary Purpose

Cancer Related Fatigue, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
accompanied and adapted water polo program
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Related Fatigue focused on measuring cancer related fatigue, adapted physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cercle des nageurs de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

accompanied and adapted water polo program

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2020
Last Updated
August 18, 2020
Sponsor
Institut Paoli-Calmettes
Collaborators
Laboratoire Management Sport Cancer EA 4670
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1. Study Identification

Unique Protocol Identification Number
NCT04235946
Brief 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
Acronym
AQUA-POLO
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Laboratoire Management Sport Cancer EA 4670

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Related Fatigue, Breast Cancer
Keywords
cancer related fatigue, adapted physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
accompanied and adapted water polo program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
accompanied and adapted water polo program
Intervention Description
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
Primary Outcome Measure Information:
Title
rate of maintenance of a high level of adherence to the program of physical activities
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Being undergoing chemotherapy treatment Unacquired healing Metastatic cancers Proven psychological pathology proven according to diagnostic criteria (DSM-V) Pregnant or lactating woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33491223778
Email
DRCI.UP@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margot Berline, MSC, MBA
Phone
33491223778
Email
BERLINEM@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique COHEN, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cercle des nageurs de Marseille
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah CALVIN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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