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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05988892
Other study ID # 23-001462
Secondary ID NCI-2023-05387
Status Recruiting
Phase N/A
First received
Last updated
Start date June 23, 2023
Est. completion date December 2024

Study information

Verified date September 2023
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if increasing physical activity (PA) will increase physical functioning, as measured by cardiovascular endurance, muscular strength, and balance in underserved adult cancer survivors > 60 years of age and/or those of any age residing at a rural address. Also, to determine if increasing PA will increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors >60 years of age and/or those of any age residing at a rural address.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult, cancer survivors (no active disease) at Mayo Clinic Health System (MCHS) in Northwest Wisconsin (NWWI) - Any stage cancer - Age =60 years residing at any address, or =18 years residing at a rural address (as defined by Rural America, census.gov) - Completed active treatment of surgery, (neo)adjuvant chemotherapy, and/or (neo) adjuvant radiation. Patients receiving adjuvant endocrine therapy, targeted therapy, or immunotherapy therapies are eligible. - Ownership of a computer/tablet/smartphone with internet access. - Willingness and ability to attend study visits. - Must be able to complete semi-tandem (10 seconds), side-by-side tandem (10 seconds and SPPB Score of >6 to qualify for virtual exercise. - Must be ambulatory without the use of assisted device(s). Exclusion Criteria: - Receiving surgery, (neo)adjuvant chemotherapy, (neo) adjuvant radiation, palliative treatment - Are already performing >150 minutes/week of moderate activity or 75 min/week of vigorous physical activity - Cancer-free for greater than 5 years - Unable to complete weekly interventions/exercise due to traveling or unable to be active for more than 7 consecutive days.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
Use Exercise to increase physical activity (PA), as measured by cardiovascular endurance, muscular strength, and balance in underserved cancer survivors >60 years of age and/or those of any age residing at a rural address and to increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors >60 years of age and/or those of any age residing at a rural address.

Locations

Country Name City State
United States Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in physical functioning using Short Physical Performance Battery Change in physical functioning based on improvement in endurance, strength, and balance assessed using Short Physical Performance Battery (SPPB) pre- and post-12-week exercise intervention. Baseline; 12 weeks
Primary Change in Quality of Life (QOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) QOL evaluated based on physical functioning and fatigue, assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) pre- and post-12-week exercise intervention. Baseline; 12 weeks
Primary Change in satisfaction using a 5-point Likert scale Satisfaction assessed using a 5-point Likert scale following 12-week exercise intervention and participant-reporting likelihood of recommending program. Baseline; 12 weeks
Primary Rate of adherence to program based on participation in virtual exercise sessions Adherence evaluated based on participation in virtual exercise sessions during 12-week exercise intervention. Baseline; 12 weeks
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