Active Living After Cancer: Implementation Within Be Well Acres Homes

NCT ID: NCT06907706

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2029-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Receives the ALAC intervention following the baseline assessment

Group Type EXPERIMENTAL

Physical Activity/Physical Functioning

Intervention Type BEHAVIORAL

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.

Quality of Life

Intervention Type BEHAVIORAL

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.

Waitlist Control

Receives the ALAC intervention following the 3-month assessment

Group Type ACTIVE_COMPARATOR

Physical Activity/Physical Functioning

Intervention Type BEHAVIORAL

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.

Quality of Life

Intervention Type BEHAVIORAL

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.

Interventions

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Physical Activity/Physical Functioning

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.

Intervention Type BEHAVIORAL

Quality of Life

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Basen-Engquist, BA,MPH,PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karen Basen-Engquist, BA,MPH,PHD

Role: CONTACT

(713) 745-3123

Facility Contacts

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Karen Basen-Engquist, BA,MPH,PHD

Role: primary

713-745-3123

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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2023-0231

Identifier Type: -

Identifier Source: org_study_id

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