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

Cancer Survivor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832154
• Other study ID #: IRB00037913
• Secondary ID: NCI-2016-00647CC
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: April 23, 2020

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor

Intervention

Other:
• Internet-Based Intervention
Complete online PA program

Procedure:
• Quality-of-Life Assessment
Ancillary studies

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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