Malignant NeoplasmNCT03679585
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
A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies how well Talking Pictures social media intervention works in reducing depressive symptoms and improving spiritual well-being and quality of life in adolescent and young adult cancer patients. Read more about this study
- Who is it for?
- Ages 15 to 34 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 13 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 34 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Talking Pictures: An Exploratory Study of a Meaning-Based Social Media Intervention for AYA Cancer Patients
This clinical trial studies how well Talking Pictures social media intervention works in reducing depressive symptoms and improving spiritual well-being and quality of life in adolescent and young adult cancer patients. Talking Pictures social media intervention may help doctors better learn how to most effectively provide psychosocial support to adolescent and young adult cancer patients.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Undergo Talking Pictures social media intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (social media intervention) | Experimental | 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. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly photo task completion rate
The observed completion rate will be described using the binomial completion proportion and its 2-sided 95% Jeffries confidence interval.
Measured: At 10 weeks
Project participation rates
Study will be deemed feasible it least 11 of 30 participants demonstrate completion of assignments
Measured: At 10 weeks
Impact of intervention on depressive symptoms as assessed by Beck Depression Inventory-II (BDI-II) total score
A series of repeated questionnaires will be conducted.
Measured: 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
A series of repeated questionnaires will be conducted.
Measured: 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
A series of questionnaires will be conducted.
Measured: Up to 2 months post intervention
Secondary outcomes (1)
Participant satisfaction rating
Satisfaction Questionnaire to be conducted
Measured: At 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start31 May 2017
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Pailler, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679585
- Sponsor's protocol ID
- i 44717
- Other IDs
- NCI-2018-00023, i 44717
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2018
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking Pictures: An Exploratory Study of a Meaning-Based Social Media Intervention for AYA Cancer Patients
- ClinicalTrials.gov ID
- NCT03679585
- Acronym / sponsor ID
- i 44717
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how well Talking Pictures social media intervention works in reducing depressive symptoms and improving spiritual well-being and quality of life in adolescent and young adult cancer patients. Talking Pictures social media intervention may help doctors better learn how to most effectively provide psychosocial support to adolescent and young adult cancer patients.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (social media intervention) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 15 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionUndergo Talking Pictures social media intervention | Other | Supportive Care (social media intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (social media intervention) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (social media intervention) |
Primary outcome
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.
Project participation rates
Time frame: At 10 weeks
Study will be deemed feasible it least 11 of 30 participants demonstrate completion of assignments
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.
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.
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.
1 secondary outcome
Participant satisfaction rating
Time frame: At 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Pailler principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly photo task completion rate (time frame: At 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.