Previvors Recharge: A Resilience Program for Cancer Previvors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06378749

Acronym

PreCharge

Enrollment

138

Registered

2024-04-22

Start date

2024-04-11

Completion date

2024-09-27

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Cancer, Mental Health Issue

Keywords

Resilience, Coping, Previvor, well-being

Brief 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 to be examined will include pre-post changes on the Connor Davidson Resilience Scale.

Interventions

BEHAVIORALPreCharge

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Connor Davidson Resilience Scale (CDRISC)	Baseline and 1 Month	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.

Secondary

Measure	Time frame	Description
Acceptance and Action Questionnaire (AAQII)	Baseline and 1 Month	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.

Other

Measure	Time frame	Description
Patient Health Questionnaire-2 (PHQ-2)	Baseline and 1 Month	The PHQ-2 inquires about the frequency of depressed mood, with a score ranging from 0 to 6 and with greater scores indicating higher likelihood of Major Depressive Disorder. 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. A score of 3 or greater on the PHQ-2 indicates that Major Depressive Disorder is likely and further evaluation is needed to assess for depression. 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.
Generalized Anxiety Disorder-2 (GAD-2)	Baseline and 1 Month	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.
Cancer Behavior Inventory (CBI-B V2.0-12)	Baseline and 1 Month	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
PreCharge Intervention Pilot After completing the baseline assessment, all pilot participants will have access to the PreCharge pilot program for 30 days. At the end of the 30 day pilot, they will be directed to the follow-up assessment. 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.	134
Total	134

Arm

Count

PreCharge Intervention Pilot

After completing the baseline assessment, all pilot participants will have access to the PreCharge pilot program for 30 days. At the end of the 30 day pilot, they will be directed to the follow-up assessment. 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.

134

Total

134

Baseline characteristics

Characteristic	PreCharge Intervention Pilot
Age, Continuous	41.67 years STANDARD_DEVIATION 10.06
Race/Ethnicity, Customized Asian or Pacific Islander	1 Participants
Race/Ethnicity, Customized Black	7 Participants
Race/Ethnicity, Customized Hispanic	8 Participants
Race/Ethnicity, Customized Mixed	4 Participants
Race/Ethnicity, Customized Other	1 Participants
Race/Ethnicity, Customized White	113 Participants
Sex: Female, Male Female	128 Participants
Sex: Female, Male Male	4 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 138
other Total, other adverse events	0 / 138
serious Total, serious adverse events	0 / 138

Outcome results

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.