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

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)

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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