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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05048316
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivor; Young Adult	Behavioral: Cognitive-Behavioral Stress Management and Health Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pilot Study to Develop a Group-Based E-Health Intervention for Young Adult Cancer Survivors
• Actual Study Start Date: Sep 15, 2021
• Actual Primary Completion Date: Jan 6, 2022
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. Session attendance after the intervention - Acceptability [Immediately after the intervention]

   Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.

Secondary Outcome Measures

1. Quality of life before intervention [Baseline]

   Participants will complete the 27-item Functional Assessment of Cancer Therapy - General

2. Change in quality of life at after intervention [Immediately after intervention]

   Participants will complete the 27-item Functional Assessment of Cancer Therapy - General

Other Outcome Measures

1. Symptom burden before intervention [Baseline]

   Participants will complete the 22-item Impact of Event Scale-Revised

2. Change in Symptom burden after intervention [Immediately after intervention]

   Participants will complete the 22-item Impact of Event Scale-Revised

3. Cancer-related distress before intervention [Baseline]

   Participants will complete the 22-item Impact of Event Scale-Revised

4. Change in cancer-related distress after intervention [Immediately after intervention]

   Participants will complete the 22-item Impact of Event Scale-Revised

5. Stress management skills self-efficacy before intervention [Baseline]

   Participants will complete subscales from the Measure of Current Status

6. Change in stress management skills self-efficacy after intervention [Immediately after intervention]

   Participants will complete subscales from the Measure of Current Status

7. Coping before intervention [Baseline]

   Participants will complete the Brief-COPE

8. Change in coping after intervention [Immediately after intervention]

   Participants will complete the Brief-COPE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

Investigators

• Principal Investigator: Laura Oswald, PhD, Moffitt Cancer Center

Study Documents (Full-Text)

• Informed Consent Form - Aug 25, 2021

More Information

Additional Information:

• Moffitt Clinical Trial Search

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT05048316
• Other Study ID Numbers: MCC-21053
• First Posted: Sep 17, 2021
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 31, 2022