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

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • 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 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

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
Intervention / Treatment
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

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

Virginia Commonwealth University

Investigators

  • 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)

October 30, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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