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Trial Title:
Previvors Recharge: A Resilience Program for Cancer Previvors
NCT ID:
NCT06378749
Condition:
Hereditary Cancer
Mental Health Issue
Conditions: Keywords:
Resilience
Coping
Previvor
well-being
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PreCharge
Description:
PreCharge is an intervention for Hereditary Cancer Syndrome Previvors that administers
brief assessments and uses multivariate algorithms and tailoring technology to provide
timely, individualized, bi-directional text messages to improve resilience and coping.
The program uses proven approaches to behavior change tailoring to increase resilience by
promoting a positive mindset, strong social connections, and a deep sense of meaning and
purpose. It will also proactively provide access to online tools prior to medical
appointments to address scanxiety (e.g., management of emotion tips; mindfulness
meditation; communication scripts; breathing exercises). At any time, users will be able
to text a trigger word to indicate that they need extra support and will receive
just-in-time assistance via text message.
Arm group label:
PreCharge Intervention Pilot
Summary:
It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes
(HCS), a cancer risk that is associated with germline mutations (inherited genetic
mutations passed directly from a parent to a child that create a genetic predisposition
to certain types of cancer). Individuals with an HCS who have never been diagnosed with
cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an
increased risk of developing multiple primary cancers during their lifetime, often with
onset at an early age. Previvors face multiple forms of adversity, including a multitude
of annual cancer screenings and the uncertainty of not only their own health but the
health of affected family members. This study will examine the acceptability and
preliminary effects of PreCharge, a resilience-boosting solution specifically designed
for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses
proven approaches to behavior change tailoring to increase resilience by promoting a
positive mindset, strong social connections, and a deep sense of meaning and purpose
while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will
be recruited for a 30-day pilot test. Participants will complete a baseline assessment,
and then be provided with 30 days of access to the PreCharge program. At the end of the
30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1)
acceptability of the program, as evidenced by obtaining 75% endorsement that users would
recommend the program to a fellow Previvor; (2) engagement as evidenced by continued
receipt of text messages and one or more interactions with the online tools by at least
70% of participants; and (3) benefit from the program, evidenced by statistically
significant pre-post improvement on the Connor Davidson Resilience Scale.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Identified as having Hereditary Cancer Syndrome
2. Never having been diagnosed with cancer
3. Over 18 years of age
4. Living in the United States
5. English speaking
6. Having a score of 26 or below on the Connor Davidson Resilience Scale (10 Item)
7. Access to a mobile phone
8. Agree to receive text messages.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Pro-Change Behavior Systems
Address:
City:
Narragansett
Zip:
02882
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kerry E Evers, PhD
Phone:
401-360-2985
Email:
kevers@prochange.com
Contact backup:
Last name:
Madison Gilmore
Phone:
401-360-2988
Email:
mgilmore@prochange.com
Investigator:
Last name:
Kerry E Evers, PhD
Email:
Principal Investigator
Start date:
April 11, 2024
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Pro-Change Behavior Systems
Agency class:
Other
Source:
Pro-Change Behavior Systems
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378749
