AQUA-POLO: 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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Unknown status

CT.gov ID

NCT04235946

Collaborator

Laboratoire Management Sport Cancer EA 4670 (Other)

Enrollment

Location

Arm

9.6

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer Related Fatigue Breast Cancer	Other: accompanied and adapted water polo program	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

rate of maintenance of a high level of adherence to the program of physical activities [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cercle des nageurs de Marseille	Marseille		France

Sponsors and Collaborators

Institut Paoli-Calmettes
Laboratoire Management Sport Cancer EA 4670

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT04235946

Other Study ID Numbers:

Aqua POLO-IPC 2019-028
2019-A03003-54

First Posted:

Jan 22, 2020

Last Update Posted:

Aug 19, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Paoli-Calmettes

cancer related fatigue

adapted physical activity

Additional relevant MeSH terms:

Breast Neoplasms

Fatigue

Study Results

No Results Posted as of Aug 19, 2020