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

NCT ID: NCT04235946

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-12-31

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.

Conditions

Cancer Related Fatigue; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

accompanied and adapted water polo program

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire Management Sport Cancer EA 4670

UNKNOWN

Sponsor Role: collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monique COHEN, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Cercle des nageurs de Marseille

Marseille, , France

Countries

France

Central Contacts

Dominique GENRE, MD

Role: CONTACT

DRCI.UP@ipc.unicancer.fr

33491223778

Margot Berline, MSC, MBA

Role: CONTACT

BERLINEM@ipc.unicancer.fr

33491223778

Facility Contacts

Sarah CALVIN

Role: primary

References

Cuvelier 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.

Reference Type: DERIVED

PMID: 37026030 (View on PubMed)

Other Identifiers

2019-A03003-54

Identifier Type: OTHER

Identifier Source: secondary_id

Aqua POLO-IPC 2019-028

Identifier Type: -

Identifier Source: org_study_id