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Clinical Trials/NCT06907706
NCT06907706RecruitingNot Applicable

Active Living After Cancer: Implementation Within Be Well Acres Homes

M.D. Anderson Cancer Center1 site in 1 country164 target enrollmentStarted: April 3, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
164
Locations
1
Primary Endpoint
Re-AIM Framework

Study Overview

Brief Summary

The goal of this research study is to learn more about a physical activity program adapted for cancer survivors.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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
  • •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.

Arms & Interventions

Waitlist Control

Active Comparator

Receives the ALAC intervention following the 3-month assessment

Intervention: Physical Activity/Physical Functioning (Behavioral)

Intervention

Experimental

Receives the ALAC intervention following the baseline assessment

Intervention: Quality of Life (Behavioral)

Intervention

Experimental

Receives the ALAC intervention following the baseline assessment

Intervention: Physical Activity/Physical Functioning (Behavioral)

Waitlist Control

Active Comparator

Receives the ALAC intervention following the 3-month assessment

Intervention: Quality of Life (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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