Trial Outcomes & Findings for Internet-Delivered Positive Affect Program in Managing Emotion in Young Adult Cancer Survivors (NCT NCT02832154)

Results Overview

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?

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

At 12 weeks

Results posted on

2020-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Age, Continuous	30.37 Years STANDARD_DEVIATION 6.62 • n=93 Participants
Sex: Female, Male Female	33 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	35 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	43 participants n=93 Participants

PRIMARY outcome

Timeframe: At 12 weeks

Population: Only 26 participants out of the 43 were analyzed for acceptability for this outcome.

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?

Outcome measures

Outcome measures
Measure	Supportive Care n=26 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Acceptability - Mean Value	8.81 score on a scale Interval 8.27 to 9.34

PRIMARY outcome

Timeframe: At 12 weeks

Population: Only 26 participants out of the 43 were analyzed for acceptability for this outcome.

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?

Outcome measures

Outcome measures
Measure	Supportive Care n=26 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Acceptability - Proportion Value	0.58 proportion of participants Interval 0.37 to 0.77

PRIMARY outcome

Timeframe: Up to 19 months

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.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Accrual	1.63 participants per month Interval 1.18 to 2.19

PRIMARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Adherence - Proportion of Completed Interventions (Mean Value)	3.30 completed interventions Standard Deviation 2.20

PRIMARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Adherence - Proportion of Completed Interventions (Proportion Value)	0.63 complete interventions Standard Deviation 0.48

PRIMARY outcome

Timeframe: At 12 weeks

The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Patients Who Refused to Participate	27 Participants

PRIMARY outcome

Timeframe: At 8 week

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

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Patient Provided Data at 8 Weeks - Retention	27 Participants

PRIMARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Adherence - Number of Completed Exercises	5.07 completed exercises Standard Deviation 3.43

PRIMARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Website Visits	15.35 website visits Standard Deviation 12.85

PRIMARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure	Supportive Care n=43 Participants 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. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Patients Provided Data at 12 Weeks - Retention	27 Participants

Adverse Events

Supportive Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study coordinator

Wake Forest University Health Sciences

Phone: 336-713-5061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place