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

Designing and Testing the Feasibility of a Theory-Based Intervention to Promote Physical Activity Among Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Sedentary Behavior; Cancer Survivors
• Intervention / Treatment: Behavioral: 12-Week Home Exercise Group; Behavioral: Education Comparison Group

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois at Urbana-Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Zoom-Based Exercise Coaching	Participants in the intervention arm will answer Likert-format questions relating to their preference, tolerance and usage of the Zoom-based group meetings to promote physical activity levels. The scale will use a 1-5 rating, with 1 being lowest preference/displeased and 10 being the highest preference/very pleased.	12 weeks
Change in average daily step count	Participants will wear a hip-based pedometer for 7 days at baseline, 12 weeks and 24 weeks.	Baseline, 12 weeks, 24 weeks
Change in minutes of daily sedentary time	The Sedentary Behavior Questionnaire (developed by Rosenberg et al., 2010) will be administered at baseline,12 weeks and 24 weeks to assess participants' time spent sitting. Questions relating to sedentary behavior cover both weekday and weekend sitting time, as well as domain-specific sedentary behaviors (i.e. occupational, transportation, and leisure sitting time).Response options for the amount of time engaged in each behavior include: none, 15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours or more. For scoring, the time spent in each behavior is converted into hours, and the hours per day for each item are summed separately for weekdays and weekend days. Higher scores indicate higher amounts of daily sitting time.	Baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of the exercise manual	Participants in both groups will answer Likert-format questions relating to their preference, usage and perceived helpfulness of the study-specific exercise manual. The scale will use a 1-10 rating, with 1 being lowest preference/displeased and 10 being the highest preference/very pleased.	12 weeks
Change in physical activity engagement	The Godin-Shepard Leisure Time Exercise Questionnaire will be administered at baseline, 12 weeks and 24 weeks to assess individuals' reported weekly frequency of engaging in light, moderate and strenuous vigorous-intensity exercise. For each intensity level, participants will report the number of times per week they engaged in an exercise bout >=10 minutes and the average duration of the bouts. For each intensity level, the number of bouts per week will be multiplied by the average duration per bout to reflect participant's average activity level.	Baseline,12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Neha P Gothe, MA, PhD, University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21591 (Other Identifier: City of Hope Medical Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No