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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05048316
Enrollment
17
Registered
2021-09-17
Start date
2021-05-11
Completion date
2022-01-06
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Survivor, Young Adult

Brief summary

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

Interventions

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.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction assessed by study-specific survey during the intervention - AcceptabilityDuring interventionThe 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 - AcceptabilityImmediately after the interventionThe 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.
Session attendance after the intervention - AcceptabilityImmediately after the interventionVideoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.

Secondary

MeasureTime frameDescription
Quality of life before interventionBaselineParticipants will complete the 27-item Functional Assessment of Cancer Therapy - General
Change in quality of life at after interventionImmediately after interventionParticipants will complete the 27-item Functional Assessment of Cancer Therapy - General

Other

MeasureTime frameDescription
Cancer-related distress before interventionBaselineParticipants will complete the 22-item Impact of Event Scale-Revised
Change in stress management skills self-efficacy after interventionImmediately after interventionParticipants will complete subscales from the Measure of Current Status
Stress management skills self-efficacy before interventionBaselineParticipants will complete subscales from the Measure of Current Status
Change in cancer-related distress after interventionImmediately after interventionParticipants will complete the 22-item Impact of Event Scale-Revised
Coping before interventionBaselineParticipants will complete the Brief-COPE
Change in coping after interventionImmediately after interventionParticipants will complete the Brief-COPE
Symptom burden before interventionBaselineParticipants will complete the 22-item Impact of Event Scale-Revised
Change in Symptom burden after interventionImmediately after interventionParticipants will complete the 22-item Impact of Event Scale-Revised

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026