- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679585
Talking Pictures Social Media Intervention in Reducing Depressive Symptoms and Improving Spiritual Well-Being and Quality of Life in Adolescent and Young Adult Cancer Patients
Talking Pictures: An Exploratory Study of a Meaning-Based Social Media Intervention for AYA Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of a 10-week application (app)-based intervention.
II. To assess the impact of the intervention on depressive symptoms, spiritual well-being and quality of life.
III. To examine the content of participants recorded narratives for salient themes related to weekly content areas (e.g. identity, meaning-making, hopes, fears) in order to better understand the unique experiences and challenges of adolescent and young adult (AYA) patients.
OUTLINE:
Participants undergo Talking Pictures social media intervention for 10 weeks, receiving weekly assignments via email with requirements to use the Pixstori app to take and upload photographs with verbal narratives attached to a website. Participants can then share their pixstories to a group page and view and respond to others' pixstories.
After completion of study, participants are followed up at 2 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescent and young adult cancer patients who were diagnosed within three years
- English comprehension in written and oral format
- Current possession of a smartphone, tablet, or computer with camera and wifi capacity or data plan
- Valid email address
- Pregnant women will be included if they meet eligibility requirements
Exclusion Criteria:
- Diagnosis of mental retardation, severe or untreated psychopathology (e.g. schizophrenia), or dementia
- Adults unable to consent: Will not include
- Prisoners will not be included given lack of access to smartphone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (social media intervention)
Participants undergo Talking Pictures social media intervention for 10 weeks, receiving weekly assignments via email with requirements to use the Pixstori app to take and upload photographs with verbal narratives attached to a website.
Participants can then share their pixstories to a group page and view and respond to others' pixstories.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo Talking Pictures social media intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly photo task completion rate
Time Frame: At 10 weeks
|
The observed completion rate will be described using the binomial completion proportion and its 2-sided 95% Jeffries confidence interval.
|
At 10 weeks
|
|
Project participation rates
Time Frame: At 10 weeks
|
Study will be deemed feasible it least 11 of 30 participants demonstrate completion of assignments
|
At 10 weeks
|
|
Impact of intervention on depressive symptoms as assessed by Beck Depression Inventory-II (BDI-II) total score
Time Frame: Up to 2 months post intervention
|
A series of repeated questionnaires will be conducted.
|
Up to 2 months post intervention
|
|
Impact of intervention on spiritual well-being as assessed by Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp) total score
Time Frame: Up to 2 months post intervention
|
A series of repeated questionnaires will be conducted.
|
Up to 2 months post intervention
|
|
Impact of intervention on psychosocial quality of life as assessed by Pediatric Quality of Life Inventory-Adolescent and Young Adult (PedsQL-AYA) psychosocial health score
Time Frame: Up to 2 months post intervention
|
A series of questionnaires will be conducted.
|
Up to 2 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant satisfaction rating
Time Frame: At 10 weeks
|
Satisfaction Questionnaire to be conducted
|
At 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Megan Pailler, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- i 44717 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2018-00023 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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