Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors (HEAL)

August 15, 2025 updated by: Virginia Commonwealth University

Feasibility and Acceptability of an Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults (EA) adapted for emerging adult cancer survivors (EACS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University, School of Medicine
        • Contact:
        • Principal Investigator:
          • Autumn Lanoye, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-29
  • Cancer diagnosis of any type
  • Body fat percentage >16.2% for women; >10.6% for men

Exclusion Criteria:

  • Individuals receiving active chemotherapy/radiation or those having completed active chemotherapy/radiation within the past 6 months
  • Individuals who are currently pregnant or lactating
  • Current involvement in a weight loss program or current use of weight loss medication
  • Individuals who report any other uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity (e.g., uncontrolled hypertension)
  • Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease)
  • Individuals with medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis (e.g., endogenous hypercortisolemia [Cushing's syndrome] or adrenal insufficiency)
  • Individuals who report a heart condition, chest pain during periods of activity or rest, or loss of consciousness as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)
  • Report of lifetime diagnosis of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors (vomiting, laxative abuse) within the previous 3 months
  • Hospitalization for depression or other psychiatric disorder within the past 12 months
  • Report of lifetime diagnosis of bipolar disorder or psychotic disorder
  • Indication of current suicidal intent
  • Inability to speak and read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Anti-Inflammatory Lifestyle Intervention
A 16-week program consisting of 12 75-minute virtual group meetings
Behavioral: Anti-Inflammatory Lifestyle Intervention
Content includes training in empirically-supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with evidence-based behavior change content adapted to meet the needs of EACS. Participants will also receive digital tools to facilitate daily self-monitoring (Fitbit activity monitor, wireless scales, self-monitoring app) and generate information for tailored weekly e-coaching

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29
Time Frame: Day 0, At end of recruitment period
The percentage of participants that enroll
Day 0, At end of recruitment period
Test the feasibility of AILI and associated research procedures among EACS age 18-29
Time Frame: 4 months
The percentage of participants that complete the post intervention questionnaire
4 months
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.
Time Frame: 4 months
The percentage of participants that complete the post intervention blood draw
4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time Frame: 4 months
The percentage of participants that complete all study sessions
4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time Frame: 4 months
The percentage of participants that wear the Fitbit >/= 60% throughout the intervention period.
4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time Frame: 4 months
Intervention satisfaction ratings>/= 4 on a 1-5 Likert scale at 4 months, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time Frame: 4 months
Research procedure satisfaction ratings>/= 3 on a 1-5 Likert scale, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Autumn Lanoye, Ph.D, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-24-21095
  • HM20029744 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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