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Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

Feasibility and Acceptability of an Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06442397
Acronym
HEAL
Enrollment
0
Registered
2024-06-04
Start date
2024-10-30
Completion date
2025-07-31
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survivorship

Keywords

Adult Cancer Survivors, Anti-Inflammatory Lifestyle for Cancer Survivors

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).

Interventions

BEHAVIORALAnti-Inflammatory Lifestyle Intervention

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

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 periodThe percentage of participants that enroll
Test the feasibility of AILI and associated research procedures among EACS age 18-294 monthsThe percentage of participants that complete the post intervention questionnaire
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.4 monthsThe percentage of participants that complete the post intervention blood draw
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.4 monthsThe percentage of participants that complete all study sessions

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026