Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

NCT06442397 | Withdrawn DMC

• 2 other identifiers: MCC-24-21095HM20029744
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Adult Cancer Survivors; Anti-Inflammatory Lifestyle for Cancer Survivors

Outcome Measures

Primary Outcomes (7)

• Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29

  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

  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.

  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.

  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.

  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.

  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.

  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

Study Arms (1)

Anti-Inflammatory Lifestyle Intervention

EXPERIMENTAL

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

Behavioral: Anti-Inflammatory Lifestyle Intervention

Interventions

Anti-Inflammatory Lifestyle Intervention BEHAVIORAL

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

Anti-Inflammatory Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Officials

• Autumn Lanoye, Ph.D

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: October 30, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share