NCT03750981

Brief Summary

This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress74%
Nov 2018Nov 2028

Study Start

First participant enrolled

November 12, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

9.1 years

First QC Date

November 15, 2018

Last Update Submit

November 4, 2025

Conditions

Outcome Measures

Primary Outcomes (15)

  • Enrollment rates

    Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll

    Baseline

  • Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program

    Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups.

    Baseline to 12 weeks

  • Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program

    Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded.

    Baseline to 12 weeks

  • Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program

    Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.

    Baseline to 12 weeks

  • Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire

    Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.

    Baseline to 12 weeks

  • Change in Body Composition

    Changes in weight in kg

    Baseline to 12 weeks

  • Change in Body Composition

    Changes in body fat percentage

    Baseline to 12 weeks

  • Change in Body Composition

    Changes in visceral fat percentage

    Baseline to 12 weeks

  • Change in Body Composition

    Changes in muscle mass percentage

    Baseline to 12 weeks

  • Change in Body Composition

    Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2

    Baseline to 12 weeks

  • Change in Body Composition

    Changes in resting metabolism value

    Baseline to 12 weeks

  • Change in Motivation

    Motivation to exercise will be collected via a survey

    Baseline to 12 weeks

  • Satisfaction with the Program

    Satisfaction with the program will be collected via a survey

    12 weeks

  • Program Adherence

    Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.

    12 weeks

  • Height

    Height will be collected in meters to use in the calculation of Body Mass Index

    Baseline

Study Arms (1)

A 12-week pilot intervention study introducing a high-intensi

OTHER
Behavioral: 12 week pilot intervention study.

Interventions

Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.

A 12-week pilot intervention study introducing a high-intensi

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or older at time of program recruitment
  • Diagnosed with any cancer
  • Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).
  • Available transportation to and from the facility on session days

You may not qualify if:

  • Widely metastatic cancers to the brain or bone may be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Study Officials

  • Jennifer Beebe-Dimmer, MPH, PhD.

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer B Beebe-Dimmer, MPH, PhD.

CONTACT

Tara Baird, M.Ed.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 23, 2018

Study Start

November 12, 2018

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations