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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
43
Northwestern University
Chicago, Illinois, United States
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
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?
Time frame: 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?
Time frame: 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.
Time frame: 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.
Time frame: At 12 weeks
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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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12 weeks