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

NCT ID: NCT02832154

Last Updated: 2020-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2020-04-23

Brief Summary

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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

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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.

Conditions

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Cancer Survivor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Complete online PA program

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Internet-Based Intervention

Complete online PA program

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Salsman

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36890329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32463014 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2016-00647

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 99516

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH084723

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00037913

Identifier Type: -

Identifier Source: org_study_id

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