Enhancing Cancer Survivorship With Pickleball

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT06048822
Collaborator
(none)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pickleball
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Project Rally: Enhancing Cancer Survivorship With Pickleball
Actual Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cancer Survivors

Participation will last approximately 4-6 months. Participants will be encouraged to attend Pickleball sessions at the YMCA at least twice a week. Each session will last 2 hours, and participants will be encouraged to attend at least one hour. Participants will receive a Fitbit to wear continuously 24/7 over 4-6 months to track steps and activity intensity. Participants will also be asked to wear an electronic device (accelerometer) over their right hip during specific time points throughout the study to better understand how pickleball participation contributes to physical activity levels.

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.

Experimental: Family or Friend of Cancer Survivors

Participation will last approximately 4-6 months. Participants will be encouraged to attend Pickleball sessions at the YMCA at least twice a week. Each session will last 2 hours, and participants will be encouraged to attend at least one hour. Participants will receive a Fitbit to wear continuously 24/7 over 4-6 months to track steps and activity intensity. Participants will also be asked to wear an electronic device (accelerometer) over their right hip during specific time points throughout the study to better understand how pickleball participation contributes to physical activity levels.

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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Recruited - Feasibility [12 months]

    The study will be deemed feasible if ≥ 50% of eligible participants are enrolled

  2. Number of Participants who Complete Baseline Data Collection and Follow up Data Collection - Feasibility [6 months]

    The study will be deemed feasible if ≥ 75% of participants who complete baseline measures also complete follow up measures

  3. Average Pickleball Session Attendance - Feasibility [6 months]

    The study will be deemed feasible if participants attend ≥ 75% of recommended sessions on average.

  4. Participant Evaluation of Feasibility and Acceptability - Acceptability [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moffitt Cancer Center Tampa Florida United States 33612

Sponsors and Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Nathan Parker, PhD, MPH, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT06048822
Other Study ID Numbers:
  • MCC-22455
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 21, 2023