- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06907706
Active Living After Cancer: Implementation Within Be Well Acres Homes
Study Overview
Status
Intervention / Treatment
Detailed Description
Primary Objectives:
Evaluate the effectiveness of ALAC adapted for delivery in Acres Homes, using a randomized wait- list-control group design. The primary outcome will be physical functioning as measured by the 30- second sit-to-stand test at 12 weeks. Secondary outcomes will include physical functioning measured by the six-minute walk, objective and self-reported physical activity, social connectedness, and quality of life. The investigators will also investigate whether program effects are maintained at 6 months. Hypothesis: Cancer survivors in the adapted ALAC program will increase their physical activity and improve their physical functioning from baseline to the end-of-intervention assessment, compared to a wait-list-control group.
Compare the reach of the ALAC program in Acres Homes to ALAC in other persistent poverty neighborhoods in Houston. Hypothesis: The Acres Homes adaptation of ALAC will have a greater reach (percent of cancer survivors enrolling in ALAC in a specific neighborhood) than in other persistent poverty neighborhoods in Houston.
Explore the moderating effects of social and environmental variables on program effectiveness. Hypothesis 3A:Participants' financial distress, experiences of discrimination, health literacy, and social connectedness will influence the effect of the ALAC intervention on participants' physical activity, physical functioning, and program engagement. Hypothesis 3B: Neighborhood characteristics, like walkability, crime rate, air quality, access to green space, and neighborhood social vulnerability, will be related to the effectiveness of the ALAC program in terms of enrollment and health outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen Basen-Engquist, BA,MPH,PHD
- Phone Number: (713) 745-3123
- Email: kbasenen@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77090
- Recruiting
- The University of Texas M. D. Anderson Cancer Center
-
Contact:
- Karen Basen-Engquist, BA,MPH,PHD
- Phone Number: 713-745-3123
- Email: kbasenen@mdanderson.org
-
Principal Investigator:
- Karen Basen-Engquist, BA,MPH,PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Past diagnosis of invasive cancer, or a caregiver (family or friend) of a participating survivor.
- No longer receiving treatment for cancer (except hormone therapy or long-term maintenance chemotherapy).
- Over the age of 18.
- Screen negative for contraindicating health problems on the adapted Physical Activity Readiness Questionnaire (PAR-Q),79 or screened positive but have approval from a health care provider to participate.
- Lives in the Acres Homes neighborhood of Houston, Texas or has a home zip code of 77088 or 77091.
- Able to provide informed consent.
Exclusion Criteria:
- Women who are pregnant (as indicated by self-report).
- Has participated in the ALAC program within the past year and attended more than 2 group sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Receives the ALAC intervention following the baseline assessment
|
The physical activity portion of the program sessions focuses on teaching cognitive and behavioral skills to increase physical activity, including goalsetting, self-monitoring, overcoming barriers to physical activity, enlisting social support, and how to handle "high risk" situations that may result in relapses to a sedentary lifestyle.
The health educator teaches participants about various forms of moderate intensity activity and has them practice brief bouts of activity of various types to ensure that they are doing the activities safely and correctly.
Each week participants receive a handout to provide information about the behavioral skill taught that week.
The program also provides activity trackers (week 1) and resistance bands (week 5).
The pedometer assists participants in self-monitoring their activity, and the resistance bands provide a form of home-based exercise that participants can do even with limited space.
The survivorship portion of the program features a guided discussion on a different topic each session.
The goals of the discussion are to present information about the topic, answer participants' questions about the topic, encourage participants to share solutions and ideas relevant to the topic with each other, and provide information on community resources participants can access if they require additional help.
The health educator makes a brief presentation about the topic, answers questions, and then asks a series of 2-3 open-ended questions to facilitate discussion about the topic.
At the end of the session, the health educator navigates participants who need additional information or service related to the topic to resources in the community.
|
|
Active Comparator: Waitlist Control
Receives the ALAC intervention following the 3-month assessment
|
The physical activity portion of the program sessions focuses on teaching cognitive and behavioral skills to increase physical activity, including goalsetting, self-monitoring, overcoming barriers to physical activity, enlisting social support, and how to handle "high risk" situations that may result in relapses to a sedentary lifestyle.
The health educator teaches participants about various forms of moderate intensity activity and has them practice brief bouts of activity of various types to ensure that they are doing the activities safely and correctly.
Each week participants receive a handout to provide information about the behavioral skill taught that week.
The program also provides activity trackers (week 1) and resistance bands (week 5).
The pedometer assists participants in self-monitoring their activity, and the resistance bands provide a form of home-based exercise that participants can do even with limited space.
The survivorship portion of the program features a guided discussion on a different topic each session.
The goals of the discussion are to present information about the topic, answer participants' questions about the topic, encourage participants to share solutions and ideas relevant to the topic with each other, and provide information on community resources participants can access if they require additional help.
The health educator makes a brief presentation about the topic, answers questions, and then asks a series of 2-3 open-ended questions to facilitate discussion about the topic.
At the end of the session, the health educator navigates participants who need additional information or service related to the topic to resources in the community.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Re-AIM Framework
Time Frame: Through study completion; an average of 1 year.
|
1. Physical functioning change from baseline to 12 weeks, as measured by the 30-second sit-to-stand test
|
Through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Basen-Engquist, BA,MPH,PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neoplasms
- Fatigue
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Public Health
- Environment and Public Health
- Health Status
- Demography
- Epidemiologic Measurements
- Exercise
- Quality of Life
Other Study ID Numbers
- 2023-0231
- NCI-2025-07494 (Other Identifier: Clinical Trials Reporting Program (CTRP))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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