NCT06048822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

September 15, 2023

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Recruited - Feasibility

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

    12 months

  • 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

  • Average Pickleball Session Attendance - Feasibility

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

    6 months

  • 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

Study Arms (2)

Cancer Survivors

EXPERIMENTAL

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

Family or Friend of Cancer Survivors

EXPERIMENTAL

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

Interventions

PickleballBEHAVIORAL

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.

Cancer SurvivorsFamily or Friend of Cancer Survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Screen failure for exercise safety based on 2023 PAR-Q+
  • For cancer survivor group, history of squamous and basal cell skin cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nathan Parker, PhD, MPH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

September 11, 2023

Primary Completion

May 10, 2024

Study Completion

May 10, 2024

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations