Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

Survivorship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442397
• Other study ID #: MCC-24-21095
• Secondary ID: HM20029744
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Tyler Phillips
• Phone: 804-828-1965
• Email: phillipst5[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• Cancer diagnosis of any type

Exclusion Criteria:

• Individuals who are currently receiving active chemotherapy and/or radiation therapy will be excluded given that their dietary and physical activity requirements may vary widely and are outside the parameters of the current study.

• Individuals who are currently pregnant or lactating will be ineligible for the current trial given different nutritional needs and potential safety concerns, as well as physiological and hormonal differences that could interfere with our ability to test the study aims.

• Current involvement in a weight loss program or current use of weight loss medication is an exclusion for the proposed trial because it undermines the internal validity of the study given we are interested in the potential of the integrated lifestyle intervention to promote weight loss. If individuals are engaging in other programs or taking medications, we would not know whether weight losses observed during this study were due to the intervention or some other weight loss method.

• Individuals will be excluded if they 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). We will refer individuals who have blood pressure levels >140/90 mmHg as part of baseline screening to their physician and exclude them from this study unless their treating physician determines s/he is a suitable candidate based on the specifics of the protocol and provides written medical consent for participation. Participants who report a history of or current treatment for medical conditions (e.g., hypertension) will be asked to obtain MD consent to participate because this treatment program involves unsupervised physical activity, as well as experiential physical activity during treatment sessions; it is important to ensure that the exercise that will be promoted in the program will be safe and appropriate for these individuals given their medical history. Similarly, this program promotes specific changes to diet which may or may not be endorsed by an individual's physician given their medical condition.

• Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) will be ineligible for participation given a heightened inflammatory response as well as the frequent use of medications that may modulate inflammation, representing a confound to test the study aims.

• Individuals with medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis (e.g., endogenous hypercortisolemia [Cushing's syndrome] or adrenal insufficiency) will be ineligible for participation as this represents a confound to test the study aims.

• 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) administered during screening will be excluded. Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate. As noted above, this treatment program involves unsupervised physical activity, as well as experiential physical activity during treatment sessions; it is important to ensure that the exercise that will be promoted in the program will be safe and appropriate for these individuals given the symptoms they have reported at screening.

• Report of lifetime diagnosis of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors (vomiting, laxative abuse) within the previous 3 months, as these individuals are at higher risk for disordered eating behaviors and their clinical history/present symptoms place them at elevated risk for potential adverse effects from participation in an intervention targeting eating and physical activity, particularly one that involves frequent self-weighing and monitoring of dietary intake.

• Hospitalization for depression or other psychiatric disorder within the past 12 months will be an exclusion given potential psychological safety concerns. Although the AILI will teach evidence-based strategies for emotion regulation and management of affective states, the program is not designed to treat mental health disorders. Moreover, individuals who have experienced severe psychological symptoms requiring hospitalization in the recent past could experience harm or worsening of symptoms because of the self-monitoring of mood/affect promoted in this study and the group discussion.

• Individuals with a lifetime history of bipolar disorder or psychotic disorder will be excluded because the proposed AILI would be poorly suited to the needs of individuals with severe mental illness and could serve to exacerbate symptoms.

• Indication of current suicidal intent as reported on the Beck Depression Inventory-II, which will be administered in person at the baseline assessment. Any individual who scores 3 on item 9 will be ineligible for the study. While suicidal ideation (i.e., thoughts of harming oneself) is common, having a plan or intent to harm oneself presents much greater risk to the individual and participation in this study would be contraindicated as the treatment program is not well suited to meet their needs and a higher level of care (e.g., individual psychological treatment) is warranted.

• Inability to speak and read English is an exclusion criterion given that all written measures and treatment materials are in English, and interventionists are English-speaking.

Related Conditions & MeSH terms

• Survivorship

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University, School of Medicine	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29	The percentage of participants that enroll	Day 0, At end of recruitment period
Primary	Test the feasibility of AILI and associated research procedures among EACS age 18-29	The percentage of participants that complete the post intervention questionnaire	4 months
Primary	Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.	The percentage of participants that complete the post intervention blood draw	4 months
Primary	Assess the acceptability of AILI and associated research procedures among EACS age 18-29.	The percentage of participants that complete all study sessions	4 months
Primary	Assess the acceptability of AILI and associated research procedures among EACS age 18-29.	The percentage of participants that wear the Fitbit >/= 60% throughout the intervention period.	4 months
Primary	Assess the acceptability of AILI and associated research procedures among EACS age 18-29.	Intervention satisfaction ratings>/= 4 on a 1-5 Likert scale at 4 months, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.	4 months
Primary	Assess the acceptability of AILI and associated research procedures among EACS age 18-29.	Research procedure satisfaction ratings>/= 3 on a 1-5 Likert scale, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.	4 months