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

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

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

Study Overview

• Status: Completed
• Conditions: Cancer Survivor; Young Adult
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Stress Management and Health Education

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eHealth; Weekly video conference groups led by a trained facilitator	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Session attendance after the intervention - Acceptability	Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.	Immediately after the intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden before intervention	Participants will complete the 22-item Impact of Event Scale-Revised	Baseline
Change in Symptom burden after intervention	Participants will complete the 22-item Impact of Event Scale-Revised	Immediately after intervention
Cancer-related distress before intervention	Participants will complete the 22-item Impact of Event Scale-Revised	Baseline
Change in cancer-related distress after intervention	Participants will complete the 22-item Impact of Event Scale-Revised	Immediately after intervention
Stress management skills self-efficacy before intervention	Participants will complete subscales from the Measure of Current Status	Baseline
Change in stress management skills self-efficacy after intervention	Participants will complete subscales from the Measure of Current Status	Immediately after intervention
Coping before intervention	Participants will complete the Brief-COPE	Baseline
Change in coping after intervention	Participants will complete the Brief-COPE	Immediately after intervention

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

General Publications

• Oswald LB, Lyleroehr M, Gudenkauf LM, Armstrong GE, Tometich DB, Sanford SD, Loecher N, Geiss C, Rodriguez Y, Scheel KL, Nieves-Lopez A, Jim HSL, Gonzalez BD, Antoni MH, Penedo FJ, Reed D, Katsanis E, Salsman JM, Victorson D, Fox RS. Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors. Support Care Cancer. 2022 Dec;30(12):10067-10076. doi: 10.1007/s00520-022-07382-y. Epub 2022 Oct 14.

Helpful Links

• Moffitt Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): January 6, 2022

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCC-21053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No