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Completed

NCT Number: NCT04498130

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

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Key information

Conditions

Cancer Survivors Behavior Exercise Motor Activity Sedentary Behavior

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-Week Home Exercise Group

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

Education Comparison Group

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.

Primary outcomes

  1. Feasibility of Zoom-Based Exercise Coaching

    Time frame: 12 weeks

    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.

  2. Change in average daily step count

    Time frame: Baseline, 12 weeks, 24 weeks

    Participants will wear a hip-based pedometer for 7 days at baseline, 12 weeks and 24 weeks.

  3. Change in minutes of daily sedentary time

    Time frame: Baseline, 12 weeks, 24 weeks

    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.

Secondary outcomes

  1. Use of the exercise manual

    Time frame: 12 weeks

    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.

  2. Change in physical activity engagement

    Time frame: Baseline,12 weeks, 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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