A Study of Physical Activity in Cancer Survivors

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05988892
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Physical Activity

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Improving Physical Activity in Rural and Older Cancer Survivors
• Actual Study Start Date: Jun 23, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Community Oncology patients entering cancer survivorship Adult Mayo Clinic Health System Northwest Wisconsin Community Oncology patients entering cancer survivorship (completed initial treatment) Underserved: Older (≥60 years), lower-income, rural, ethnic/racial minority, lacking access/available/acceptable forms of exercise programs

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.

Outcome Measures

Primary Outcome Measures

1. Change in physical functioning using Short Physical Performance Battery [Baseline; 12 weeks]

   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.

2. Change in Quality of Life (QOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) [Baseline; 12 weeks]

   QOL evaluated based on physical functioning and fatigue, assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) pre- and post-12-week exercise intervention.

3. Change in satisfaction using a 5-point Likert scale [Baseline; 12 weeks]

   Satisfaction assessed using a 5-point Likert scale following 12-week exercise intervention and participant-reporting likelihood of recommending program.

4. Rate of adherence to program based on participation in virtual exercise sessions [Baseline; 12 weeks]

   Adherence evaluated based on participation in virtual exercise sessions during 12-week exercise intervention.

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Health System-Eau Claire Clinic	Eau Claire	Wisconsin	United States	54701

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Kaye T. Sturz, APRN, CNP, Mayo Clinic Health System in Eau Claire

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05988892
• Other Study ID Numbers: 23-001462; NCI-2023-05387
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mayo Clinic: Rural; Physical Activity

Study Results

No Results Posted as of Aug 15, 2023