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

Not Applicable

Completed

• Conditions: Cancer Survivor
• Interventions: Other: Internet-Based Intervention; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02832154
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

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 Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-14
• Study Start: 2017-04-21
• Primary Completion: 2019-04-23
• Study Completion: 2020-04-23
• Results First Submitted: 2020-05-13
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Results First Posted: 2020-07-16
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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Exclusion Criteria

• Evidence of a cancer recurrence
• History of multiple primary cancers
• Currently receiving palliative or hospice care
• Significant psychiatric history

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care	Questionnaire Administration	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.
Supportive Care	Internet-Based Intervention	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.
Supportive Care	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
Adherence - Number of Completed Exercises	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.
Acceptability - Mean Value	At 12 weeks	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?
Number of Patients Who Refused to Participate	At 12 weeks	The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.
Number of Patient Provided Data at 8 Weeks - Retention	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
Adherence - Proportion of Completed Interventions (Mean Value)	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.
Adherence - Proportion of Completed Interventions (Proportion Value)	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.
Number of Patients Provided Data at 12 Weeks - Retention	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.
Number of Website Visits	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.
Acceptability - Proportion Value	At 12 weeks	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?
Accrual	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.

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States