Clinical trial NCT04498130: Feasibility of a Novel, Theory Based Physical Activity Intervention Among Adult Cancer Survivors
Official title: Designing and Testing the Feasibility of a Theory-Based Intervention to Promote Physical Activity Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Exercise
Sedentary Behavior
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Feasibility of Zoom-Based Exercise Coaching
timeFrame: 12 weeks
measure: Change in average daily step count
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in minutes of daily sedentary time
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Use of the exercise manual
timeFrame: 12 weeks
measure: Change in physical activity engagement
timeFrame: Baseline,12 weeks, 24 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Neha P Gothe, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References: