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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer Survivor

Intervention / Treatment
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* Other: Internet-Based Intervention
* Procedure: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care<br>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: Internet-Based Intervention<br>* Complete online PA program<br>Procedure: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |