Feasibility of a Novel, Theory Based Physical Activity Intervention Among Adult Cancer Survivors

NCT ID: NCT04498130

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-02
• Study Completion Date: 2022-12-31

Brief Summary

As the number of cancer survivors grows and expected survival time increases, the health behaviors of this population are gaining significant attention from the research and public health community. Adoption or maintenance of healthy lifestyles after cancer has the potential to reduce both cancer- and non-cancer-related morbidity and mortality. Exercise adoption and maintenance remains a significant challenge for adults, especially clinical populations such as cancer survivors who may struggle with comorbidities, symptoms and side-effects of the disease or medications, and overall compromised health and functioning. A number of site-based exercise interventions have been conducted to promote physical activity, often using a theoretical basis to design and execute the intervention. Although these programs are successful in exposing cancer survivors to regular physical activity, they often struggle with exercise maintenance after the conclusion of the structured site-based group exercise sessions. The goal of the proposed project is to enhance physical activity engagement among adult cancer survivors by designing a home-based program using the socio-ecological framework and employing constructs from social cognitive theory to guide participants through the project.

Conditions

Cancer Survivors; Exercise; Sedentary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

12-Week Home Exercise Group

The 12-week theory-based physical activity intervention will involve mailing participants an exercise manual with health and exercise information (i.e. information about exercising safely, modules related to the social cognitive theory, weekly goal setting worksheets, exercise-tracking logs, etc.), a resistance band, and a standard Omron pedometer. Participants will receive a weekly 30-minute Zoom--based group meetings to discuss different strategies to begin and maintain a consistent exercise routine and access to a social media page to facilitate social support and interaction among the group participants. Participants will be able to join the group if they would like, but it will not be required. Participants will be encouraged to connect with each other to promote social support and social modeling. Lastly participants will receive a weekly exercise video to follow along with on their own time and tailored weekly step goals.

Group Type: EXPERIMENTAL

12-Week Home Exercise Group

Intervention Type: BEHAVIORAL

12 week home-based program consisting of: weekly Zoom group chats; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page

Educational Comparison Group

The education group participants will receive the same exercise manual, fitness items, exercise videos, and same weekly tailored step goal as the 12-week intervention group. This group will not have weekly zoom discussions, or be a part of the same social media page as the 12-week intervention group. Instead, the education group will be contacted by research staff once a week via telephone to discuss their manuals and activity for the week, and to ensure they have been safely engaging in exercise. A separate social media page will be created for this group, where pre-existing materials related to physical activity recommendations, benefits, other resources, and more will be shared.

Group Type: ACTIVE_COMPARATOR

Education Comparison Group

Intervention Type: BEHAVIORAL

12 week home-based program consisting of: weekly check-in phone calls; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page.

Interventions

12-Week Home Exercise Group

12 week home-based program consisting of: weekly Zoom group chats; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page

Intervention Type: BEHAVIORAL

Education Comparison Group

12 week home-based program consisting of: weekly check-in phone calls; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 30-75 years of age at baseline
• Cancer diagnosis during adulthood (no childhood cancers)
• Low-active (≤ 2 days of 30 minutes of structured exercise/week)
• At least 1 month since last cancer treatment (surgery, chemotherapy and/or radiation)
• No reservations from a doctor/physician/oncologist to engage in physical activity
• Not currently undergoing cancer-related treatment
• No active cancer diagnosis
• Willingness to participate in a 12-week home exercise program
• Willingness to be randomized to either the 12-week home exercise or a 12 week education group
• Access to a laptop/ phone with Zoom web-conferencing software
• An active email address to receive and sign the electronic informed consent
• Willingness to complete study questionnaires before and after the 12-week program, and 3 months after the program
• Fluency in English

Exclusion Criteria

• Below 30 or above 75 of age at baseline
• Childhood cancer diagnosis only
• High active (> 2 days of 30 minutes of structured exercise/week)
• Cancer treatment within the last month or currently undergoing treatment
• Advised to refrain from physical activity by a doctor/physician/oncologist
• Active cancer diagnosis
• Not willing to participate in a 12-week home exercise group and/or complete study assessments
• Not willing to be randomized into one of the two study groups
• No access to a laptop/phone with Zoom software
• No access to active email
• Not fluent in English

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neha P Gothe, MA, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Countries

United States

Other Identifiers

21591

Identifier Type: -

Identifier Source: org_study_id