Previvors Recharge: A Resilience Program for Cancer Previvors

Mental Health Issue Clinical Trial

— PreCharge  

Official title:

Previvors Recharge: A Resilience Program for Cancer Previvors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378749
• Other study ID #: 1R43CA275673
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Pro-Change Behavior Systems
• Contact: Kerry E Evers, Ph.D.
• Phone: 401-360-2985
• Email: kevers[@]prochange.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Cancer
• Mental Health Issue

Intervention

Behavioral:
• PreCharge
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.

Locations

Country	Name	City	State
United States	Pro-Change Behavior Systems	Narragansett	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Health Questionnaire-2 (PHQ-2)	The PHQ-2 inquires about the frequency of depressed mood, with a score ranging from 0 to 6. The authors identify a cut-off score of 3 as the optimal cut point for screening purposes, and stated that a cut point of 2 would enhance sensitivity.; The PHQ-2, comprising the first 2 items of the PHQ-9, inquires about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks.	Baseline and 1 Month
Other	Generalized Anxiety Disorder-2 (GAD-2)	The Generalized Anxiety Disorder two questions scale (GAD-2) is an ultra brief and easy to perform initial screening tool for Generalized Anxiety Disorder (GAD). The two questions are rated on a zero to three scale for a total score of zero to six with greater scores indicating higher likelihood of Generalized Anxiety Disorder. A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted.	Baseline and 1 Month
Other	Cancer Behavior Inventory (CBI-B V2.0-12)	The short version of the Cancer Behavior Inventory (CBI-B: 12 items) measures self-efficacy for coping which has been shown to have a positive impact on wellbeing, quality of life, anxiety, and depression in cancer patients, even after treatment. Each item is rated on a 1 to 9 scale for a total score range of 12-108 with higher scores indicating higher levels of confidence.	Baseline and 1 Month
Other	Net Promoter Score (NPS)	The Net Promoter Score (NPS) measures program users' experience and predicts the growth of program use. It is a widely accepted single-item satisfaction measure, "How likely is it that you would recommend this program to a friend or colleague?" will be responded to on a scale from 0=extremely unlikely to 10=extremely likely by users.	1 month follow-up
Primary	Connor Davidson Resilience Scale (CDRISC)	This 10-item scale assesses five factors related to resilience. Each item is rated on a 5-point scale with higher scores reflecting greater resilience. Scores range from 0-40. There are well-established norms across a variety of populations and the scale has been used as an outcome measure to evaluate a variety of different intervention programs.	Baseline and 1 Month
Secondary	Cantril/Gallup Life Evaluation Index	In its World Poll administered in 150 countries, Gallup, Inc. uses the 2-item Cantril Self-Anchoring Scale and a simple scoring algorithm to assess subjective well-being. Respondents are asked to rate their current life-and then to rate their future life, "say about five years from now"-on a ladder where 0 represents the worst possible life and 10 best possible life. Individuals who rate their current life a "7" or higher AND their future life an "8" or higher are classified as "thriving." Individuals who rate their current and future lives a "4" or lower are classified as "suffering." All others are "struggling." Previous research has shown that those classified as thriving experience less depressive symptoms, higher physical and emotional health and have fewer health risk behaviors than those in struggling and suffering.	Baseline and 1 Month
Secondary	Acceptance and Action Questionnaire (AAQII)	The Acceptance and Action Questionnaire - version 2 (AAQII), is the most widely used measure of psychological flexibility. Higher total scores on the 7-item scale indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility and normative values are available. Scores range from 7 to 49.	Baseline and 1 Month