Study to Develop a Group-Based E-Health Intervention for YA Cancer Survivors

Not Applicable

Completed

• Conditions: Young Adult; Cancer Survivor
• Interventions: Behavioral: Cognitive-Behavioral Stress Management and Health Education

• Registration Number: NCT05048316
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Primary Completion: 2022-01-06
• Study Completion: 2022-01-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• 18-39 years old
• Diagnosed with cancer between 18-39 years old
• Cancer diagnosis was non-metastatic
• Completed cancer treatment between 1 month and 5 years prior to enrollment, with the exception of ongoing hormone therapy
• No documented or observable psychiatric or neurological disorders that could interfere with participation (e.g., active psychosis, active substance abuse), as identified by the referring medical team, chart review, or screening
• Able to speak and read English
• Able to provide informed consent

Exclusion Criteria

• Metastatic disease
• Continued cancer treatment
• Psychiatric or neurological disorders that could interfere with study participation
• Vulnerable populations will not be included

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eHealth	Cognitive-Behavioral Stress Management and Health Education	Weekly video conference groups led by a trained facilitator

Primary Outcome Measures

Name	Time	Method
Session attendance after the intervention - Acceptability	Immediately after the intervention	Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.
Satisfaction assessed by study-specific survey during the intervention - Acceptability	During intervention	The intervention will be deemed acceptable if, on average, participants report satisfaction with the weekly sessions as ≥2 on a 0-4 scale.
Satisfaction assessed by study-specific survey after the intervention - Acceptability	Immediately after the intervention	The intervention will be deemed acceptable if, on average, participants report satisfaction with the overall program and intent to continue using the intervention skills as ≥2 on a 0-4 scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life before intervention	Baseline	Participants will complete the 27-item Functional Assessment of Cancer Therapy - General
Change in quality of life at after intervention	Immediately after intervention	Participants will complete the 27-item Functional Assessment of Cancer Therapy - General

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States