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Completed

NCT Number: NCT02832154

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

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.

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Key information

Conditions

Cancer Survivor

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Based Intervention

Other

Complete online PA program

quality-of-life assessment

Procedure

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Acceptability - Mean Value

    Time frame: 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?

  2. Acceptability - Proportion Value

    Time frame: 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?

  3. Accrual

    Time frame: 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.

  4. Adherence - Proportion of Completed Interventions (Mean Value)

    Time frame: 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.

  5. Adherence - Proportion of Completed Interventions (Proportion Value)

    Time frame: 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.

  6. Number of Patients Who Refused to Participate

    Time frame: At 12 weeks

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

  7. Number of Patient Provided Data at 8 Weeks - Retention

    Time frame: 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

  8. Adherence - Number of Completed Exercises

    Time frame: 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.

  9. Number of Website Visits

    Time frame: 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.

  10. Number of Patients Provided Data at 12 Weeks - Retention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 14, 2016
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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