Clinical trial NCT05048316: Study to Develop a Group-Based E-Health Intervention for YA Cancer Survivors
Official title: Pilot Study to Develop a Group-Based E-Health Intervention for Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Young Adult
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction assessed by study-specific survey during the intervention - Acceptability
timeFrame: During intervention
measure: Satisfaction assessed by study-specific survey after the intervention - Acceptability
timeFrame: Immediately after the intervention
measure: Session attendance after the intervention - Acceptability
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Quality of life before intervention
timeFrame: Baseline
measure: Change in quality of life at after intervention
timeFrame: Immediately after intervention
Other outcomes:
measure: Symptom burden before intervention
timeFrame: Baseline
measure: Change in Symptom burden after intervention
timeFrame: Immediately after intervention
measure: Cancer-related distress before intervention
timeFrame: Baseline
measure: Change in cancer-related distress after intervention
timeFrame: Immediately after intervention
measure: Stress management skills self-efficacy before intervention
timeFrame: Baseline
measure: Change in stress management skills self-efficacy after intervention
timeFrame: Immediately after intervention
measure: Coping before intervention
timeFrame: Baseline
measure: Change in coping after intervention
timeFrame: Immediately after intervention
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Laura Oswald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.