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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04235946
• Other study ID #: Aqua POLO-IPC 2019-028
• Secondary ID: 2019-A03003-54
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 33491223778
• Email: DRCI.UP[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Related Fatigue
• Fatigue

Intervention

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

Locations

Country	Name	City	State
France	Cercle des nageurs de Marseille	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Laboratoire Management Sport Cancer EA 4670

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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