NCT06907706

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
36mo left

Started Apr 2023

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Apr 2023Apr 2029

Study Start

First participant enrolled

April 3, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

5.1 years

First QC Date

March 14, 2025

Last Update Submit

March 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Re-AIM Framework

    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.

Study Arms (2)

Intervention

EXPERIMENTAL

Receives the ALAC intervention following the baseline assessment

Behavioral: Physical Activity/Physical FunctioningBehavioral: Quality of Life

Waitlist Control

ACTIVE COMPARATOR

Receives the ALAC intervention following the 3-month assessment

Behavioral: Physical Activity/Physical FunctioningBehavioral: Quality of Life

Interventions

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.

InterventionWaitlist Control
Quality of LifeBEHAVIORAL

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.

InterventionWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77090, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

ExerciseQuality of Life

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Karen Basen-Engquist, BA,MPH,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Basen-Engquist, BA,MPH,PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

April 2, 2025

Study Start

April 3, 2023

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2029

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations