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

NCT04235946 | Unknown

• 2 other identifiers: Aqua POLO-IPC 2019-0282019-A03003-54
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer Related Fatigue; Breast Cancer

Keywords

cancer related fatigue; adapted physical activity

Outcome Measures

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.

  20 WEEKS

Study Arms (1)

accompanied and adapted water polo program

EXPERIMENTAL

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

accompanied and adapted water polo program 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

accompanied and adapted water polo program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman aged 18 to 65, with a good understanding and good practice of the French language.
• 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).

You may not qualify if:

• Being undergoing chemotherapy treatment
• Unacquired healing
• Metastatic cancers
• Proven psychological pathology proven according to diagnostic criteria (DSM-V)
• Pregnant or lactating woman

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead
• Laboratoire Management Sport Cancer EA 4670: collaborator

Study Sites (1)

Cercle des nageurs de Marseille

Marseille, France

Location

Related Publications (1)

• 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.

  PMID: 37026030 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monique COHEN, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

33491223778; DRCI.UP@ipc.unicancer.fr

Margot Berline, MSC, MBA

CONTACT

33491223778; BERLINEM@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: March 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)