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Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

Not Applicable
Recruiting
Conditions
Survivorship
Interventions
Behavioral: Anti-Inflammatory Lifestyle Intervention
Registration Number
NCT06442397
Lead Sponsor
Virginia Commonwealth University
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.

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).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
19
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Anti-Inflammatory Lifestyle InterventionAnti-Inflammatory Lifestyle InterventionA 16-week program consisting of 12 75-minute virtual group meetings
Primary Outcome Measures
NameTimeMethod
Test the feasibility of AILI and associated research procedures among EACS age 18-294 months

The percentage of participants that complete the post intervention questionnaire

Assess the acceptability of AILI and associated research procedures among EACS age 18-29.4 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.

Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.4 months

The percentage of participants that complete the post intervention blood draw

Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29Day 0, At end of recruitment period

The percentage of participants that enroll

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Virginia Commonwealth University, School of Medicine

🇺🇸

Richmond, Virginia, United States

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