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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498130
• Other study ID #: 21591
• Status: Completed
• Phase: N/A
• Start date: October 2, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivors
• Exercise
• Sedentary Behavior

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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