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

NCT02832154 | Completed Results DMC

• 5 other identifiers: IRB00037913NCI-2016-00647CCCWFU 99516P30CA012197R01MH084723
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer Survivor

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Supportive Care

EXPERIMENTAL

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; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Complete online PA program

Supportive Care

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care

Questionnaire Administration OTHER

Ancillary studies

Supportive Care

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read and understand English
• Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Salsman JM, McLouth LE, Tooze JA, Little-Greene D, Cohn M, Kehoe MS, Moskowitz JT. An eHealth, Positive Emotion Skills Intervention for Enhancing Psychological Well-Being in Young Adult Cancer Survivors: Results from a Multi-Site, Pilot Feasibility Trial. Int J Behav Med. 2023 Oct;30(5):639-650. doi: 10.1007/s12529-023-10162-5. Epub 2023 Mar 8.

  PMID: 36890329 DERIVED

• Salsman JM, McLouth LE, Cohn M, Tooze JA, Sorkin M, Moskowitz JT. A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2020 May 28;9(5):e17078. doi: 10.2196/17078.

  PMID: 32463014 DERIVED

Results Point of Contact

• Title: Study coordinator
• Organization: Wake Forest University Health Sciences

drlittle@wakehealth.edu

336-713-5061

Study Officials

• John Salsman

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: July 14, 2016
• Study Start: April 21, 2017
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2020
• Last Updated: July 16, 2020
• Results First Posted: July 16, 2020

Record last verified: 2020-07

Locations

US (2)