NCT04171609

Brief Summary

The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2020

Completed
Last Updated

August 25, 2020

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

November 19, 2019

Last Update Submit

August 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in resilience as measured by the Connor-Davidson Resilience Scale

    This 25-item scale addresses resilience, and has been studied in a variety of populations. Resilience is considered as the capacity to overcome adversity.

    Baseline, 6 months

Secondary Outcomes (5)

  • Post-writing survey

    1 day (collected during the 1-day intervention)

  • Change in quality of life as measured by the Quality of Life Patient/Cancer Survivor Version (QOL-CSV)

    Baseline, 6 months

  • Change in perceived stress as measured by Perceived Stress Scale (PSS-10)

    Baseline, 6 months

  • Change in depression as measured by Center for Epidemiological Studies Depression Scale Revised (CESD-R)

    Baseline, 6 months

  • Qualitative follow-up questionnaire

    6 months

Study Arms (1)

Cancer survivors

EXPERIMENTAL

Adult survivors of any kind of cancer (except for minor skin cancer) are eligible to participate

Behavioral: Expressive writing

Interventions

During this daylong expressive writing workshop intervention, the writing instructor coached participants through a series of simple writing exercises. Participation required neither any prior writing experience, nor any desire to become a writer. The practices cultivate natural abilities to express the ideas that define who you are and how you experience your life.

Cancer survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have ever received a cancer diagnosis
  • Have completed cancer treatment (e.g., surgery, radiation, or chemotherapy)
  • Are able to speak, read, write, and understand English
  • Are cognitively able to provide consent
  • Are able to travel to Durham to participate in the 1-day writing intervention

You may not qualify if:

  • Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Oliver Glass, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

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

November 19, 2019

First Posted

November 21, 2019

Study Start

July 19, 2019

Primary Completion

May 14, 2020

Study Completion

May 14, 2020

Last Updated

August 25, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations