Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

NCT ID: NCT06442397

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-07-31

Brief Summary

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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

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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).

Conditions

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Survivorship

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Anti-Inflammatory Lifestyle Intervention

A 16-week program consisting of 12 75-minute virtual group meetings

Group Type EXPERIMENTAL

Anti-Inflammatory Lifestyle Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Anti-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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Autumn Lanoye, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Other Identifiers

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HM20029744

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-24-21095

Identifier Type: -

Identifier Source: org_study_id

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