Clinical trial NCT06907706: Active Living After Cancer: Implementation Within Be Well Acres Homes
Official title: Active Living After Cancer: Implementation Within Be Well Acres Homes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Fatigue
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Past diagnosis of invasive cancer, or a caregiver (family or friend) of a participating survivor.
2. No longer receiving treatment for cancer (except hormone therapy or long-term maintenance chemotherapy).
3. Over the age of 18.
4. 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.
5. Lives in the Acres Homes neighborhood of Houston, Texas or has a home zip code of 77088 or 77091.
6. Able to provide informed consent.

Exclusion Criteria:

1. Women who are pregnant (as indicated by self-report).
2. Has participated in the ALAC program within the past year and attended more than 2 group sessions.

Primary outcomes:
measure: Re-AIM Framework
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, BA,MPH,PHD
role: PRINCIPAL_INVESTIGATOR
References: