Clinical trial NCT02832154: Internet-Delivered Positive Affect Program in Managing Emotion in Young Adult Cancer Survivors
Official title: Enhancing Management of Patient Reported Outcomes With Emotion Regulation (EMPOWER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Mental Health (NIMH)
First posted: 2016-07-14
Enrollment: 43
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: This pilot clinical trial studies how well an internet-delivered positive affect (PA) intervention works in managing emotion in young adult cancer survivors. An internet-delivered PA intervention may teach younger cancer survivors healthy coping skills and help doctors to learn more about what effects mood may have on the health and well-being of young adults with cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors.

II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability.

SECONDARY OBJECTIVES:

I. To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors.

OUTLINE:

Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.

After completion of study, patients are followed up at 1 and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Able to read and understand English
* Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
* 18 to 39 years of age at diagnosis
* Within 0-5 years post-active treatment
* Wireless internet connection or a home computer that is connected to the internet

Exclusion Criteria:

* Evidence of a cancer recurrence
* History of multiple primary cancers
* Currently receiving palliative or hospice care
* Significant psychiatric history

Primary outcomes:
measure: Acceptability - Mean Value
timeFrame: At 12 weeks
measure: Acceptability - Proportion Value
timeFrame: At 12 weeks
measure: Accrual
timeFrame: Up to 19 months
measure: Adherence - Proportion of Completed Interventions (Mean Value)
timeFrame: At 12 weeks
measure: Adherence - Proportion of Completed Interventions (Proportion Value)
timeFrame: At 12 weeks
measure: Number of Patients Who Refused to Participate
timeFrame: At 12 weeks
measure: Number of Patient Provided Data at 8 Weeks - Retention
timeFrame: At 8 week
measure: Adherence - Number of Completed Exercises
timeFrame: At 12 weeks
measure: Number of Website Visits
timeFrame: At 12 weeks
measure: Number of Patients Provided Data at 12 Weeks - Retention
timeFrame: At 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John Salsman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salsman JM, McLouth LE, Cohn M, Tooze JA, Sorkin M, Moskowitz JT. A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2020 May 28;9(5):e17078. doi: 10.2196/17078.