Enhancing Cancer Survivorship With Pickleball

Cancer Clinical Trial

Official title:

Project Rally: Enhancing Cancer Survivorship With Pickleball

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048822
• Other study ID #: MCC-22455
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Nathan Parker, PhD, MPH
• Phone: 813-745-0527
• Email: Nathan.Parker[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the feasibility and acceptability of a pickleball program for cancer survivors and their family members or friends. The program is designed to increase physical activity, improve wellness, and allow individuals to work together to learn and practice the sport.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• History of a cancer diagnosis excluding squamous and basal cell skin cancers

• Able to speak and read English

• Able to provide informed consent

• Able to pass a 2023 Physical Activity Readiness Questionnaire+ (PAR-Q+) (with appropriate physician clearance(s), as necessary)

• History of cancer diagnosis will be required for cancer survivor group; friend or family partners can be (but do not need to be) cancer survivors.

Exclusion Criteria:

• Screen failure for exercise safety based on 2023 PAR-Q+

• For cancer survivor group, history of squamous and basal cell skin cancers

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Pickleball
Participants will be encouraged to attend =2 pickleball sessions per week, with the YMCA offering 5 sessions per week. Sessions will last 2 hours, with participants encouraged to attend =1 hour. New players will receive instruction from a YMCA exercise trainer with a USA Pickleball Association Instructor Certification during sessions. At the end of each session, the YMCA trainer will note on attendance sheets whether participants engaged in training/skill development, open play, or both. Participants will be encouraged to engage in 5-10 minutes of structured warm-up exercise (i.e., walking laps around the courts and dynamic and static muscle stretches) prior to playing in each session, and they will be encouraged to perform cool-down stretches after they complete each session.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Recruited - Feasibility	The study will be deemed feasible if = 50% of eligible participants are enrolled	12 months
Primary	Number of Participants who Complete Baseline Data Collection and Follow up Data Collection - Feasibility	The study will be deemed feasible if = 75% of participants who complete baseline measures also complete follow up measures	6 months
Primary	Average Pickleball Session Attendance - Feasibility	The study will be deemed feasible if participants attend = 75% of recommended sessions on average.	6 months
Primary	Participant Evaluation of Feasibility and Acceptability - Acceptability	Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores =4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.	6 months

External Links

•   Moffitt Clinical Trial Search