Clinical trial NCT05054569: Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors
Official title: Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2021-09-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors.

Detailed description: In the first part of this study, the investigators adapted an evidence-based intervention for improving HRQOL to better meet the needs of young adult cancer survivors, and then conducted focus groups with young adult cancer survivors to get feedback on the adapted intervention. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the adapted intervention will be delivered over videoconference via weekly group meetings with a trained facilitator over the course of 10 weeks.

Eligibility criteria: Inclusion Criteria:

* age 18-39 years at the time of participation
* diagnosed with a non-metastatic primary cancer between 18-39 years old
* completed primary cancer treatment (excepting hormone therapy) 1 month to 5 years prior to enrollment
* able to speak and read English
* access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

Exclusion Criteria:

* metastatic disease
* psychiatric or neurological disorders that could interfere with study participation
* considered part of a vulnerable population

Primary outcomes:
measure: Acceptability of the adapted intervention
timeFrame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
measure: Acceptability of the adapted intervention
timeFrame: Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session
measure: Acceptability of the adapted intervention
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in symptom burden from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in cancer-related distress from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in stress management skills self-efficacy from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change in coping from baseline to immediately after the intervention
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
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.