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NCT05048316 Clinical Trial

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

Cancer Survivor Clinical Trial

Official title:
Pilot Study to Develop a Group-Based E-Health Intervention for Young Adult Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05048316
Other study ID # MCC-21053
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2021
Est. completion date January 6, 2022

Study information
Verified date April 2023
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date January 6, 2022
Est. primary completion date January 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive-Behavioral Stress Management and Health Education
Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.

Locations
Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Symptom burden before intervention Participants will complete the 22-item Impact of Event Scale-Revised Baseline
Other Change in Symptom burden after intervention Participants will complete the 22-item Impact of Event Scale-Revised Immediately after intervention
Other Cancer-related distress before intervention Participants will complete the 22-item Impact of Event Scale-Revised Baseline
Other Change in cancer-related distress after intervention Participants will complete the 22-item Impact of Event Scale-Revised Immediately after intervention
Other Stress management skills self-efficacy before intervention Participants will complete subscales from the Measure of Current Status Baseline
Other Change in stress management skills self-efficacy after intervention Participants will complete subscales from the Measure of Current Status Immediately after intervention
Other Coping before intervention Participants will complete the Brief-COPE Baseline
Other Change in coping after intervention Participants will complete the Brief-COPE Immediately after intervention
Primary Satisfaction assessed by study-specific survey during the intervention - Acceptability The intervention will be deemed acceptable if, on average, participants report satisfaction with the weekly sessions as =2 on a 0-4 scale. During intervention
Primary Satisfaction assessed by study-specific survey after the intervention - Acceptability 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. Immediately after the intervention
Primary Session attendance after the intervention - Acceptability Videoconference delivery will be acceptable if average group attendance is =6/10 sessions. Immediately after the intervention
Secondary Quality of life before intervention Participants will complete the 27-item Functional Assessment of Cancer Therapy - General Baseline
Secondary Change in quality of life at after intervention Participants will complete the 27-item Functional Assessment of Cancer Therapy - General Immediately after intervention
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