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| ID | Type | Description | Link |
|---|---|---|---|
| HM20029744 | Other Identifier | Virginia Commonwealth University |
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Unable to enroll a sufficient number of participants to launch a cohort despite increased recruitment efforts
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-Inflammatory Lifestyle Intervention | Experimental | A 16-week program consisting of 12 75-minute virtual group meetings |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Inflammatory Lifestyle Intervention | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Assess the acceptability of AILI and associated research procedures among EACS age 18-29. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Autumn Lanoye, Ph.D | Virginia Commonwealth University | Principal Investigator |
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There are no plans to share individual participant data at this time.
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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 |