Clinical trial NCT06442397: Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
Official title: Feasibility and Acceptability of an Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Survivorship
Keywords: Adult Cancer Survivors
Anti-Inflammatory Lifestyle for Cancer Survivors
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29
timeFrame: Day 0, At end of recruitment period
measure: Test the feasibility of AILI and associated research procedures among EACS age 18-29
timeFrame: 4 months
measure: Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.
timeFrame: 4 months
measure: Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
timeFrame: 4 months
measure: Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
timeFrame: 4 months
measure: Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
timeFrame: 4 months
measure: Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University, School of Medicine
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Autumn Lanoye, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: