Internet-Delivered Positive Affect Program in Managing Emotion in Young Adult Cancer Survivors

Enhancing Management of Patient Reported Outcomes With Emotion Regulation (EMPOWER)

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivor
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Quality-of-Life Assessment; Other: Internet-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care; 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Internet-Based Intervention; Complete online PA program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability - Mean Value	Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?	At 12 weeks
Acceptability - Proportion Value	Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?	At 12 weeks
Accrual	Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution.	Up to 19 months
Adherence - Proportion of Completed Interventions (Mean Value)	Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions.	At 12 weeks
Adherence - Proportion of Completed Interventions (Proportion Value)	Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions.	At 12 weeks
Number of Patients Who Refused to Participate	The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.	At 12 weeks
Number of Patient Provided Data at 8 Weeks - Retention	Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site	At 8 week
Adherence - Number of Completed Exercises	Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.	At 12 weeks
Number of Website Visits	Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.	At 12 weeks
Number of Patients Provided Data at 12 Weeks - Retention	Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.	At 12 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: John Salsman, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00037913; P30CA012197 (U.S. NIH Grant/Contract); NCI-2016-00647 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 99516 (Other Identifier: Comprehensive Cancer Center of Wake Forest University); R01MH084723 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No