Trial Outcomes & Findings for Previvors Recharge: A Resilience Program for Cancer Previvors (NCT NCT06378749)

NCT ID: NCT06378749

Last Updated: 2025-05-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

138 participants

Primary outcome timeframe

Baseline and 1 Month

Results posted on

2025-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	138
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants did not answer male or female and are not included in these percentages.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PreCharge Intervention Pilot n=134 Participants 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.
Age, Continuous	41.67 years STANDARD_DEVIATION 10.06 • n=134 Participants
Sex: Female, Male Female	128 Participants n=132 Participants • Two participants did not answer male or female and are not included in these percentages.
Sex: Female, Male Male	4 Participants n=132 Participants • Two participants did not answer male or female and are not included in these percentages.
Race/Ethnicity, Customized White	113 Participants n=134 Participants
Race/Ethnicity, Customized Black	7 Participants n=134 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	1 Participants n=134 Participants
Race/Ethnicity, Customized Mixed	4 Participants n=134 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=134 Participants
Race/Ethnicity, Customized Other	1 Participants n=134 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PreCharge Intervention Pilot n=134 Participants 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.
Connor Davidson Resilience Scale (CDRISC) Post Intervention (30 days)	23.53 score on a scale Standard Deviation 4.86
Connor Davidson Resilience Scale (CDRISC) Baseline	22.59 score on a scale Standard Deviation 4.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PreCharge Intervention Pilot n=134 Participants 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.
Acceptance and Action Questionnaire (AAQII) Baseline	27.21 score on a scale Standard Deviation 6.97
Acceptance and Action Questionnaire (AAQII) Post-Intervention (30 days)	25.05 score on a scale Standard Deviation 7.15

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PreCharge Intervention Pilot n=134 Participants 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.
Patient Health Questionnaire-2 (PHQ-2) Baseline	1.79 score on a scale Standard Deviation 1.55
Patient Health Questionnaire-2 (PHQ-2) Post Intervention (30 days)	1.26 score on a scale Standard Deviation 1.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PreCharge Intervention Pilot n=134 Participants 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.
Generalized Anxiety Disorder-2 (GAD-2) Baseline	2.81 score on a scale Standard Deviation 1.70
Generalized Anxiety Disorder-2 (GAD-2) Post Intervention (30 days)	2.16 score on a scale Standard Deviation 1.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PreCharge Intervention Pilot n=134 Participants 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.
Cancer Behavior Inventory (CBI-B V2.0-12) Baseline	69.16 score on a scale Standard Deviation 16.04
Cancer Behavior Inventory (CBI-B V2.0-12) Post Intervention (30 Days)	76.12 score on a scale Standard Deviation 15.99

Adverse Events

PreCharge Intervention Pilot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kerry E. Evers

Pro-Change Behavior Systems, Inc.

Phone: 4013602985

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place