- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413991
Expressive Writing Program Among Young Adults With Blood Cancer
An Expressive Writing Program to Support Emotional Wellness Among Young Adults With Hematologic Malignancy
The goal of this study is to learn more about an expressive writing workshop among people with blood cancer. The main question it aims to answer is whether and how an expressive writing workshop can impact mental wellness.
Participants will
- Take part in an online expressive writing workshop for four weeks
- Take three surveys at different times over 12 weeks Researchers will compare changes in mental wellness reported by the participants of the workshop to those who will wait four weeks to start the workshop. After four weeks, the participants who are waiting will start their workshop.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to learn more about an expressive writing workshop among people with blood cancer. The main question it aims to answer is whether and how an expressive writing workshop can impact mental wellness.
Participants will
- Take part in an online expressive writing workshop for four weeks
- Take three surveys at different times over 12 weeks Participants will be randomly assigned to one of two study groups by chance. Group 1 will start the workshop the following week. Group 2 will wait 4 weeks before starting the workshop. The workshop is the same for both groups. Each week, participants will be given a writing prompt and asked to spend at least 15 minutes writing a response. They will be able to share their writing response in a private online community group if they would like, but sharing is not required.
Researchers will then compare changes in mental wellness between group 1 and 2.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Coordinator
- Phone Number: 914-821-8862
- Email: researchprograms@bloodcancerunited.org
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20005
- Recruiting
- Blood Cancer United
-
Contact:
- Research Coordinator
- Phone Number: 914-821-8862
- Email: infocenter@bloodcancerunited.org
-
Contact:
- D
- Phone Number: +1 914 821 8305
-
Principal Investigator:
- Elisa S Weiss, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient with a hematologic malignancy diagnosis in treatment or after treatment is completed, who is currently between the ages of 18 and 39 (young adult), or the informal caregiver of a young adult blood cancer patient
- Located within the U.S., Canada, or U.S. territories
- Able to read and write in English
Exclusion Criteria:
- Located outside of the U.S., Canada, or its territories
- Participant is a minor aged 17 years or below
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Primary Intervention Group
|
Group 1 will start the workshop the following week.
Group 2 will wait 4 weeks before starting the workshop.
There is an equal chance of being placed group 1 or group 2.
You cannot choose your study group.
The workshop is the same for both groups.
|
|
Placebo Comparator: Group 2
Wait List Control Group
|
Group 1 will start the workshop the following week.
Group 2 will wait 4 weeks before starting the workshop.
There is an equal chance of being placed group 1 or group 2.
You cannot choose your study group.
The workshop is the same for both groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Wellbeing
Time Frame: Baseline, 4, and 8 weeks
|
Participants' mental wellbeing will be evaluated using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), specifically the original 14-item scale developed by researchers at the University of Warwick and the University of Edinburgh in 2007.
This self-report questionnaire asks questions about participants' feelings and how they have been functioning over the last two weeks to capture a comprehensive view of their recent mental wellbeing.
Participants will rate each question on a 5-point Likert scale, and their responses will be totaled to a mental wellbeing score ranging from 14-70; higher scores indicate greater wellbeing.
|
Baseline, 4, and 8 weeks
|
|
Perceived Stress
Time Frame: Baseline, 4, and 8 weeks
|
A self-report questionnaire captures whether participants perceive different life situations as overwhelming or uncontrollable.
Participants will rate each question on a 5-point Likert scale, and their responses will be totaled to a stress score ranging from 0-40, with higher score indicated more perceived stress.
|
Baseline, 4, and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCU26-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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