Recruiting

AILI

Sponsor:

Virginia Commonwealth University

Code:

NCT06442397

Conditions

Survivorship

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

Anti-Inflammatory Lifestyle Intervention

Study Details

Brief summary:

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

Conditions

Survivorship

Study ID

NCT06442397

Start date

Oct 30, 2024

Status verified date

Feb, 2025

Completion date

Oct 30, 2025

Anticipated

Primary completion date

Oct 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

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 Design

Enrollment

19 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Anti-Inflammatory Lifestyle Intervention

A 16-week program consisting of 12 75-minute virtual group meetings

Interventions

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

Primary outcome measure

  • 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 ]
  • Test the feasibility of AILI and associated research procedures among EACS age 18-29 [ Time Frame: 4 months ]
  • Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29. [ Time Frame: 4 months ]
  • Assess the acceptability of AILI and associated research procedures among EACS age 18-29. [ Time Frame: 4 months ]
  • Assess the acceptability of AILI and associated research procedures among EACS age 18-29. [ Time Frame: 4 months ]
  • Assess the acceptability of AILI and associated research procedures among EACS age 18-29. [ Time Frame: 4 months ]
  • Assess the acceptability of AILI and associated research procedures among EACS age 18-29. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Tyler Phillips

804-828-1965phillipst5@vcu.edu

Locations

Virginia Commonwealth University, School of Medicine

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Tyler Phillips

804-828-1965phillipst5@vcu.edu

Principal Investigator:

Autumn Lanoye, Ph.D

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Keywords

  • Adult Cancer Survivors
  • Anti-Inflammatory Lifestyle for Cancer Survivors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2025-02-24.