ClinicalTrials.Veeva

Menu

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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Enrolling

Conditions

Survivorship

Treatments

Behavioral: Anti-Inflammatory Lifestyle Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06442397
MCC-24-21095
HM20029744 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment

16 estimated patients

Sex

All

Ages

18 to 29 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Anti-Inflammatory Lifestyle Intervention
Experimental group
Description:
A 16-week program consisting of 12 75-minute virtual group meetings
Treatment:
Behavioral: Anti-Inflammatory Lifestyle Intervention

Trial contacts and locations

1

Loading...

Central trial contact

Massey Cancer Prevention & Control Team; Tyler Phillips

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems