Evaluating the feasibility and acceptability of study procedures for a full factorial trial of ASCENT: protocol for a randomized pilot

Abstract

Background

Adolescent and young adult cancer survivors (AYACS), aged 15–39, experience higher rates of depressive symptoms (25%–32%) compared to their non-cancer peers or older cancer survivors. While mobile health applications have shown promise in managing physical symptoms, their efficacy in addressing depression in AYACS remains underexplored. This study aims to evaluate the feasibility and acceptability of study procedures for a full factorial trial that will identify the optimal components of a digital tool (ASCENT) designed to promote self-management of depressive symptoms among AYACS.

Methods

Using a full factorial design, we will randomize 16 AYACS who have completed cancer treatment within the past 5 years to 1 of 16 conditions. The primary outcome for this study is the acceptability of study procedures, evaluated via an investigator-developed acceptability survey. Further, semi-structured exit interviews will be conducted to characterize reasons for aspects of the study with sub-optimal acceptability. Quantitative and qualitative data will also be collected on secondary outcomes including the feasibility of study procedures (as measured by recruitment and retention rates), participant use of and engagement with ASCENT, and participant feedback on ASCENT (e.g., usability, acceptability, and satisfaction).

Discussion

This pilot trial will assess the acceptability and feasibility of study procedures for a full factorial trial that will optimize a digital tool targeting depressive symptom self-management in AYACS. Findings will inform adjustments to enhance the design and implementation of a fully powered trial.

Trial registration

This trial was prospectively registered in ClinicalTrials.gov (NCT06420193) on May 17, 2024, https://clinicaltrials.gov/study/NCT06420193 . All items from the World Health Organization Trial Registration Data Set are listed in the table below.

Supplementary Information

The online version contains supplementary material available at 10.1186/s40814-025-01728-z.

Background

There are ~2.1 million adolescent and young adult (ages 15–39) cancer survivors (AYACS) in the USA, and this number is likely to grow as the incidence of cancer in this age group is rising [1]. AYACS experience disruptions to achieving developmental milestones (e.g., completion of education, child bearing), which can result in elevated depressive symptoms compared to healthy peers and other cancer survivors [2–4]. Among AYACS, the prevalence of depression ranges from 25% to 32% [5]. Elevated depressive symptoms can result in poorer quality of life, lower adherence to medical recommendations, increased healthcare costs, and elevated mortality risk [6–8]. Unlike other factors that contribute to these problematic outcomes (e.g., genetics), symptoms of depression are treatable and an ideal target for behavioral interventions. Despite this, few interventions have specifically targeted depressive symptoms in AYACS, and existing interventions have limited evidence for efficacy [9]. There is a critical need for efficacious interventions to manage depressive symptoms in AYACS.

Despite the high prevalence of depression in AYACS, much of the research on evidenced-based interventions for the management of depressive symptoms in cancer survivors has been with older breast cancer survivors [10]. Typically, interventions have been in-person during normal business hours, resulting in barriers to participation (e.g., distance, limited clinician availability “after hours”) that are problematic for AYACS who may have competing commitments such as work and parenting [11]. Therefore, it is important to develop interventions that can be delivered remotely and on demand, allowing for greater reach [12]. Several studies have demonstrated the feasibility and acceptability of mobile health applications for self-management of physical symptoms among AYACS [13]; however, few digital interventions targeting depressive symptoms among AYACS have been robustly evaluated.

The digital health interventions for depression in AYACS that have been examined have yielded mixed results. In 2017, Campo and colleagues examined AYACS psychosocial outcomes following an 8-week mindful self-compassion videoconference intervention. Results showed diminished depressive symptoms in AYACS and supported feasibility and acceptability [14]. However, the study was not a randomized controlled trial, and all 25 participants were well-educated females, limiting generalizability.

Sansom-Daly and colleagues developed “Recapture Life,” a psychologist-led videoconference intervention for AYACS based in Australia. Using CBT-based components that were modified to fit AYACS lifestyles and concerns, “Recapture Life” has demonstrated safety, acceptability, and feasibility [15–17]. As part of a 2021 efficacy study of “Recapture Life,” participants were assigned to either a CBT intervention group, a peer support group, or a control group [18]. The researchers did not find significant differences in depressive symptoms 6 weeks after the intervention between the peer support and CBT intervention groups, but participants in the CBT intervention group reported using more adaptive coping skills. However, at 12 months post-intervention, the researchers saw higher levels of depressive symptoms in the CBT intervention group compared to the peer support group [18]. Later analyses suggested that participants who had completed their cancer treatment earlier responded more positively to the intervention compared to those who had more recently completed treatment. Thus, findings are promising, but additional investigation and modifications to the timing of the intervention may be necessary.

More recently, a technology-assisted CBT (tCBT) intervention involving virtual coaches for AYACS, called “Mind Your Total Health” (MYTH), was developed [19]. Zhang and colleagues’ feasibility findings showcased that the participants who received tCBT had significantly lower post-treatment depression scores compared to the individuals in the active control group.

Finally, Salsman and colleagues created a digital health positive emotions intervention for AYACS, named “Enhancing Management of Psychological Outcomes With Emotion Regulation” (“EMPOWER”). Recent studies on EMPOWER have demonstrated its feasibility and acceptability as well as proof of concept for enhancing well-being and reducing distress [20, 21], and their full factorial trial represents the largest trial of an intervention targeting psychosocial well-being in AYACS to date [22]. Although EMPOWER does not specifically aim to manage depression in AYACS, its focus on promoting positive affect using positive psychology informed the current study’s interventional components and design. Further, similar multicomponent, positive psychology-based intervention with older cancer survivors has shown benefits for reduced depressive symptoms [23].

Altogether, current empirical evaluations of digital health interventions targeting depression in AYACS are somewhat ambiguous. These results, which have largely been limited by small sample sizes and a lack of efficacy findings, are both encouraging and suggestive of a need for further evaluation and modification [24]. Additional research is necessary to better understand what evidence-based digital interventions are most likely to improve AYACS ability to manage depressive symptoms.

Rationale

Our team developed a digital tool, ASCENT (which stands for AYA Survivors Coping and Emotional Needs Toolkit), which aims to help AYACS manage symptoms of depression post-treatment. Developed through a rigorous user-centered design process, this tool consists of 5 components—1 psychoeducational component called “Feeling,” which provides AYACS with information about cancer and depression, and 4 intervention components, which have been adapted from existing evidence-based treatments for depression. Specifically, the “Doing” component is an adaptation of behavioral activation; the “Thinking” component is an adaptation of cognitive restructuring; the “Being” component is an adaptation of mindfulness-based stress reduction; and the “Positivity” component is an adaptation of a suite of promising positive psychology interventions adapted from EMPOWER [20, 21]. Each of these interventions has been adapted for digital delivery and tailored to the needs, preferences, and experiences of AYACS [25, 26]. Further, the interventions are being delivered via a platform that has already demonstrated feasibility and acceptability with this population [20, 21]. Specifically, the Feeling module provides six lessons of general psychoeducational content about AYACS and depression, including overlap between late effects of treatment and depressive symptoms, the importance of peer support, and crisis management. All users are also asked to track their mood daily using a 5-point scale of emoji icons. Each adapted EBI was included as a separate module of six sequential lessons based on established treatment protocols. Within each lesson, psychoeducational content is presented via a brief, animated video. Users are then asked to answer multiple-choice questions to encourage engagement with the video content. Next, users are asked to watch a video or read a blog about the experience of another AYACS that is relevant to the psychoeducational content and reflect on their own experiences by responding to open-ended questions. Finally, users were asked to use a “tool” relevant to the concept at such as setting a goal or completing a guided mindfulness meditation. Users were encouraged to use tools repeatedly to practice the skills they have learned by using ASCENT. Additional features of the tool aimed at increasing engagement include an “unlocking” feature in which AYACS must complete tasks to gain access to additional lessons and tools, the ability to pin tools to their dashboard and favorite videos so they are easier to return to, and a discussion board to interact with other users. Given that ASCENT is a web-based application, users are also able to use device-provided features such as voice dictation to complete open-ended questions.

Guided by the Multiphase Optimization Strategy (MOST) for intervention development, we plan to conduct a full factorial trial to determine which components are efficacious in reducing depressive symptoms among AYACS so that we can package the most promising components into an intervention to be tested in a randomized controlled trial. MOST is a framework designed to optimize interventions by systematically evaluating the impact of different components. It involves multiple phases, starting with the preparation phase to design and pilot the intervention, followed by an optimization phase where a factorial experiment identifies the most effective components, and concluding with an evaluation phase in which efficacy is tested. The MOST approach allows an intervention to be fine-tuned to ensure its efficacy and efficiency [27–29]. As part of the preparation phase, this study aims to establish the feasibility and acceptability of our study procedures for the full factorial trial in the optimization phase.

Methods/design

Aim

The primary aim of this study is to evaluate the acceptability of study procedures for a full factorial trial of a digital intervention (ASCENT) designed to improve AYACS self-management of depressive symptoms. The secondary aims of this study are to assess the feasibility of study procedures (as measured by recruitment rate and retention rate), evaluate participant use of and engagement with ASCENT, and obtain participant feedback on ASCENT (e.g., usability, acceptability, and satisfaction).

Study design and setting

The present study is a mixed methods feasibility randomized trial with 16 parallel arms, consistent with the design of the planned full factorial trial (see Fig. 1). Each of the 4 candidate components—Doing, Thinking, Being, and Positivity—has 2 possible levels: “on” or “off.” All participants, including those randomized to have all candidate components “off” (condition 16 in Fig. 1), will receive the constant component (Feeling) which includes mood tracking, psychoeducation about cancer and depression, and resources for emergent mental health concerns. As the primary aim of this study is to assess the feasibility and acceptability of the study procedures, the sample size of N = 16 was set primarily for practical reasons and not driven by hypothesis testing or allowing for precise effect size estimates. A secondary consideration for sample size is the precision of the estimate for the acceptability survey. Assuming a standard deviation of 0.5 for the acceptability measure, rated on a four-point scale, a 95% confidence interval would have a width of 0.54.

Fig. 1.

Randomization scheme

Participants will be randomized to one condition/arm using a randomized list of the 16 conditions to be assigned based on the order of enrollment. To maintain a reproducible audit trail, the seed-protected file will be uploaded to a locked repository. This randomized list was generated by AMS (who was not involved in recruitment/enrollment) using the following code in R:

All participants will be recruited from ECU Health; however, all study procedures will be conducted online via the ASCENT platform (for intervention delivery and collection of back-end usage data), Research Electronic Data Capture (REDCap; for obtaining informed consent and collection of self-report data) [30], and Microsoft Teams (for orientation calls and exit interviews). Recruitment will occur in 2 waves, with 8 participants each, to allow for minor changes to enhance study procedures between waves.

Eligibility criteria

The study will include 16 AYACS that meet the criteria outlined in Table 1. This will allow for 1 participant to be enrolled in each condition. Of note, participants will be permitted to access any other mental health care they need throughout the trial.

Table 1.

Eligibility criteria

	Adolescents	Emerging adults	Young adults
Inclusion criteria
Age at enrollment	15–17	18–25	26–39
Age at diagnosis	12–17	15–25	15–39
Time since completion of treatment	1 month to 5 years
Language	Fluent in English (spoken and written)
Technology	Own smartphone with data plan
Exclusion criteria
Mental health	Current diagnosis of a severe/persistent mental illness
Suicidality	Severe suicidal ideation (including plan and intent)

Participant identification, recruitment, and consent/assent

Identification

Potentially eligible AYACS will be identified through reports pulled from the electronic medical record or local cancer registry and physician referrals.

Identification via report

Reports of patients who have been diagnosed with cancer within the last 10 years and are currently between the ages of 15–39 will be obtained from existing ECU Health records. Study staff will review the information contained in the report and identify patients for which additional medical record review is warranted. For those patients, study staff will conduct a detailed hand screening of the medical record to evaluate whether the patient is potentially eligible. Documentation of information relevant to screening will be recorded in a REDCap database, including whether the patient is potentially eligible. If eligibility is unclear, study staff will request the PI (KMI) to conduct an additional review of the medical record and decide whether to proceed with recruitment. For those patients identified as potentially eligible, study staff will send an Epic message to their physician to explain the nature of the study and inform them of their patient’s potential eligibility. Physicians will be asked to reply to this Epic message within 3 business days if they have any concerns about our contacting this patient for study participation. If the physician does not respond within this time frame, we will consider this as passive approval of our plan to contact the patient regarding study participation.

Identification via physician referral

The study team will share information about the study with physicians that are likely to treat AYACS at ECU Health, including a flyer for physicians and a flyer for patients. Physicians will be asked to share the patient flyer with individuals they believe are potentially eligible for the study to allow for self-referral. Interested patients will be asked to contact our study staff via phone or e-mail. Upon receipt of a self-referral, study staff will ask the patient to complete a questionnaire meant to evaluate their eligibility for the study; if they screen as potentially eligible, they will be asked to consent to participate. A review of the medical record will be completed for these patients upon receipt of the signed consent form with an integrated waiver of HIPAA authorization.

Recruitment and informed consent of emerging and young adults

Recruitment

Potentially eligible young adults will be contacted via electronic patient portal message, e-mail, and/or phone call. Initially, we will contact potentially eligible participants through two Epic MyChart messages (patient portal), e-mail (if MyChart messaging is unavailable), or phone (if both MyChart messaging and e-mail are unavailable). The first message will provide information about the study, and the second will serve as a follow-up if there is no response within 3 business days. If the young adult does not respond to either message, we will proceed with three phone call attempts. Across all modes of contact, we will attempt to reach potentially eligible participants no more than five times before receiving a response. Follow-up contacts will occur at intervals of 3 business days, unless the young adult specifies a preferred call back time or indicates a specific date by which they will complete the screening form. In such cases, a follow-up contact will occur after the specified date or time. All contacts with potential participants will be documented in REDCap.

Interested adults will be directed to a recruitment website with information about the study and to complete an online screening form via REDCap. Eligible patients will be automatically prompted to complete the consent/assent form(s) on REDCap. AYACS for which the screening survey cannot determine eligibility will be contacted by study staff for additional screening, then manually sent the consent form if eligibility is confirmed.

As part of the screening process, young adults will be asked item 9 of the PHQ-9 (“In the past two weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?”) to evaluate suicidal ideation [28]. If a young adult endorses suicidal ideation (i.e., indicates any frequency greater than “Not at all”), they will automatically be presented with a text that encourages them to call the National Suicide Prevention Lifeline at 1–800-273–8255 and/or 9-1-1 if they are considering harming or killing themselves. In addition, the PI (KMI, a licensed clinical psychologist) will receive an automated e-mail. The PI will promptly review the young adult’s relevant responses and decide how to follow up, which will generally include calling the patient for further assessment of ideation using the ASQ Suicide Risk Screening Tool [31]. Following an assessment of ideation, the PI will develop a follow-up plan using clinical judgment based on the data and any additional information acquired through the interview. The follow-up plan may include referral for more appropriate care, such as specialized treatment, or contacting psychiatric liaison teams in the local police department to conduct a health and safety check and possibly to hospitalize the patient.

Informed consent

Patients who have been confirmed eligible will be directed to the online consent form in REDCap. Patients will review and be able to save a copy of a form containing the relevant information necessary for them to make an informed decision about participation. Consent will be obtained through REDCap by checking a box to confirm consent as the research presents minimal risk of harm to subjects and involves no procedures for which written consent is typically required outside the research context (e.g., online survey or asking individuals for their opinions on a web-based tool).

Recruitment, parental permission, and assent of adolescents

Parent contacts for recruitment

For potentially eligible adolescents, their parent/legal guardian as documented in the medical record will be contacted via electronic patient portal message, e-mail, and/or phone call. Initially, the parent/legal guardian will be contacted to obtain their consent for their adolescent’s participation in the study. The first contact will be made through two Epic MyChart messages (patient portal), e-mail (if MyChart messaging is unavailable), or phone (if MyChart messaging and e-mail are unavailable). The first message will provide information about the study, and the second will serve as a follow-up if there is no response within 3 business days. If there is no response to either MyChart message, we will proceed with up to three phone call attempts. Once the parent/legal guardian provides consent, the adolescent will be asked to provide assent for participation. Across all modes of contact, we will attempt to reach the parent/legal guardian of potentially eligible participants no more than five times before receiving a response. Follow-up contacts will occur at intervals of 3 business days, unless the parent/legal guardian specifies a preferred callback time or indicates a specific date by which they will complete the screening form. In such cases, follow-up will occur after the specified date or time. All contacts with the parent/legal guardian will be documented in REDCap.

Parental permission

Parents/guardians who are interested in having their child participate in the study will be directed to a recruitment website with information about the study and asked to complete an online screening form via REDCap. If their child is eligible, the parent/guardian will be automatically prompted to complete a parental permission form in REDCap. For adolescents for whom the screening survey cannot determine eligibility, the parent/legal guardian will be contacted by study staff for additional screening and then manually sent the parental permission form if eligibility is confirmed. Parents/legal guardians who provide permission for their child to participate will be asked to provide contact information for their child.

Adolescent contacts for recruitment

Upon receipt of parental permission and the adolescent’s contact information, study staff will contact the adolescent via e-mail and/or phone call. Initially, we will contact adolescents through two e-mails. The first e-mail will provide information about the study, and the second will serve as a follow-up if there is no response within 3 business days. If the adolescent does not respond to either e-mail, we will proceed with three phone call attempts. Across all modes of contact, we will attempt to reach potentially eligible adolescents no more than five times before receiving a response. Follow-up contacts will occur at intervals of 3 business days, unless the adolescent specifies a preferred call back time or indicates a specific date by which they will complete the screening form. In such cases, follow-up will occur after the specified date or time. All contacts with potential participants will be documented in REDCap.

Adolescents who are interested in participating in the study will be asked to complete an abbreviated screening form primarily meant to evaluate suicidal ideation that their parent may not be aware of. Adolescents will be asked item 9 of the PHQ-9 (“In the past two weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?”) to evaluate suicidal ideation [28]. If an adolescent endorses suicidal ideation (i.e., indicates any frequency greater than “Not at all”), they will automatically be presented with text that encourages them to call the National Suicide Prevention Lifeline at 1–800-273–8255 and/or 9-1-1 if they are considering harming or killing themselves. In addition, the PI (KMI, a licensed clinical psychologist) will receive an automated e-mail. The PI will promptly review the adolescent’s relevant responses and decide how to follow up, which will generally include calling the patient for further assessment of ideation using the ASQ Suicide Risk Screening Tool [31]. Following an assessment of ideation, the PI will develop a follow-up plan using clinical judgment based on the data and any additional information acquired through the interview. This may include contacting the adolescent’s parent, referral for more appropriate care, such as specialized treatment, or contacting psychiatric liaison teams in the local police department to conduct a health and safety check and possibly to hospitalize the patient.

Adolescent assent

Adolescents who have been confirmed to be eligible will be directed to the online assent form in REDCap. This assent process will include informing the adolescent of the study’s purposes, procedures, and their right to withdraw at any time. Patients will review and be able to save a copy of a form containing the relevant information necessary for them to make an informed decision about participation. Assent will be obtained through REDCap by checking a box to confirm consent as the research presents minimal risk of harm to subjects and involves no procedures for which written consent is typically required outside the research context (e.g., online survey or asking individuals their opinions on a web-based tool).

Baseline assessment (−T1)

At baseline, participants will be asked to provide demographic and clinical information (including other mental health treatments) and complete the measures we plan to administer during the full factorial trial. This includes the primary outcome of interest for the trial (depressive symptoms), secondary outcomes of interest, and hypothesized mechanisms via which each of the intervention components is expected to work. See Table 2 for a complete listing of measures and timepoints of administration.

Table 2.

Schedule of enrollment, interventions, and assessments [32–53]

*Indicates pilot secondary outcomes that are also planned to be included as moderators in the subsequent full factorial trial

Orientation call (T0)

Following their completion of the baseline questionnaire, participants will be contacted by a study team member to schedule a study orientation session to be held via Microsoft Teams. During this orientation session, study staff (KMI, RG, LW, AC, RA, or AA) will review the planned schedule for assessments and associated compensation (see Table 3) and confirm their willingness to participate in the planned study procedures. If the patient confirms their willingness to participate, study staff will review the randomization scheme and assign them the next available condition; at this point, the participant is considered enrolled in the study. Study staff will then briefly introduce ASCENT and the intervention components to which they have been assigned and provide expectations for completion of content within these intervention components based on which condition they have been randomized to. We will recommend that participants complete 1 lesson of each component they are assigned to each week of the intervention period. Study staff will also schedule the participant for an exit interview to be completed after the intervention period. Participants will be blinded to their intervention assignment. Unblinding will only be permissible if a participant experiences possible intervention-related deterioration.

Table 3.

Assessment and compensation schedule

Assessment	Will be sent to you on…	Must be completed by…	Compensation
Baseline questionnaire	Already completed		$30
Week 1 questionnaire	Orientation date + 7 days	Orientation date + 8 days	$5
Week 2 questionnaire	Orientation date + 14 days	Orientation date + 15 days	$5
Week 3 questionnaire	Orientation date + 21 days	Orientation date + 22 days	$5
Week 4 questionnaire	Orientation date + 28 days	Orientation date + 29 days	$5
Week 5 questionnaire	Orientation date + 35 days	Orientation date + 36 days	$5
BONUS for completing ALL 5 weekly questionnaires		Orientation date + 36 days	$15
Follow-up questionnaire	Orientation date + 42 days	Orientation date + 45 days	$40
Exit interview—scheduled for [day] [date] at [time]			$40

Intervention period (T1–T5)

During the 6-week intervention period, participants will be asked to complete the intervention components to which they have been assigned on the ASCENT platform. We will recommend that participants complete 1 lesson for each component they are assigned to each week of the intervention period. However, they will be able to choose which lesson(s) they complete that week. Participants will receive daily text message reminders to access ASCENT to improve intervention adherence.

Participants will also be asked to complete weekly measures (at the end of weeks 1–5) of the primary outcome of interest for the trial (depressive symptoms), selected secondary outcomes for the trial, and the hypothesized mechanisms via which each of the intervention components is expected to work (see Table 2). Data on adherence to intervention components will be collected automatically via the ASCENT platform.

Participants will be monitored throughout the intervention period. Specifically, the PROMIS depression CAT scores >70 (severe range) and substantial deterioration (a >5 T-score point increase on the PROMIS depression CAT between 2 assessment points) will trigger an automated e-mail to the clinical research coordinator and to the PI. Additionally, manual monitoring will occur in all intervention components. Any open-ended text provided through the intervention site will be monitored for words or phrases entered by a participant that may constitute risk, including the words “kill,” “end it,” “suicide,” and “don’t want to live,” at least weekly by study staff. Study staff will alert the PI to any concerning content immediately via e-mail and/or phone. Upon receiving automated or staff alerts, the PI, a licensed clinical psychologist, will review all data and will initiate any necessary actions to ensure participant safety, including reviewing existing data from questionnaires, calling the patient for further evaluation, referring for treatment, or calling 911 to initiate a health and safety check by local police or safety officials if harm to self or others is identified.

Follow-up assessment (T6)

At the end of week 6 of the intervention period, participants will be asked to provide updates on any changes to the clinical information. Additionally, they will complete measures of the primary outcome of interest for the trial (depressive symptoms), secondary outcomes for the trial, hypothesized mechanisms via which each of the intervention components is expected to work, self-reported engagement with ASCENT, and acceptability of study procedures and ASCENT (see Table 2 for a complete list of T6 measures). Finally, participants will complete a virtual exit interview to allow for an in-depth conversation regarding their experience participating in the study. Interviews will be audio and video recorded and transcribed using our institution’s secure videoconferencing platform, Microsoft Teams.

Adverse event reporting

An adverse event is defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the individual’s participation in the research. Adverse events encompass both physical and psychological harms. Throughout this study, data will be collected on adverse events via participant self-report weekly. When a participant reports an adverse event, the PI will complete an Unanticipated Problem Determination Worksheet provided by the East Carolina University’s University & Medical Center Institutional Review Board (UMCIRB). Any adverse event determined to be an unanticipated problem involving risks to participants or others using this worksheet will promptly be reported to the UMCIRB via the Reportable Event feature within the eIRB system.

Data management and security

All data will be collected and managed electronically using REDCap, Microsoft Teams, and ASCENT. REDCap is a secure web-based software platform designed to support data capture for research studies [29] and is hosted by East Carolina University. It provides an intuitive interface for validated data capture, audit trails for tracking data manipulation and export procedures, automated export procedures for seamless data downloads to common statistical packages, and procedures for data integration and interoperability with external sources. Correspondence with participants will be stored in REDCap and/or the research team’s shared e-mail archive. Identifiable data will be stored on a secure drive managed by East Carolina University and only accessible onsite or via VPN access; specifically, data downloaded from REDCap will be immediately moved to the secure folder. The PI (KMI) manages access to this drive and ensures it is only accessible to members of the study team per the IRB-approved protocol. ASCENT is hosted and managed by BrightOutcome Inc. in a web-based HIPAA-compliant environment secured with the TLS 1.2 protocol. Back-end usage data downloaded from ASCENT is linked to participants only by their participant ID, which is entered by study staff when they are registered on the platform.

Upon completion of primary data cleaning and analysis, study staff will make a copy of the full dataset and delete all variables containing any of the 18 HIPAA identifiers; this anonymized data set will be archived and stored in a data repository (OSF). A file containing identifiable information will be retained for 3 years following study completion on the secure drive managed by East Carolina University; this file will be permanently deleted 3 years after study completion. Given the minimal risk of participation in this study and the use of single blinding, a data monitoring committee was not formed. All available data will be analyzed as collected.

Proposed study endpoints

The primary outcome for this study is the acceptability of study procedures. Acceptability will be evaluated via an investigator-developed acceptability survey at T6. Further, semi-structured exit interviews will be conducted to characterize reasons for sub-optimal acceptability. Secondary outcomes for this study include the feasibility of study procedures (as measured by recruitment rate [percentage of participants enrolled out of the number contacted] and retention rate [percentage of enrolled participants who complete the T6 assessment]), self-reported engagement with ASCENT, back-end metrics of ASCENT usage to provide information about intervention adherence, and participant feedback on ASCENT (e.g., usability, acceptability, and satisfaction). Exit interviews will also be used to collect qualitative data on these secondary outcomes. Study staff will encourage participants to complete study measures even if they decide to discontinue the use of ASCENT.

Study status

Recruitment for this study began on August 28, 2024. Wave 1 recruitment (n = 8) was completed on November 7, 2024. A preliminary review of participant feedback informed minor changes to study and intervention procedures, such as providing participants with additional instructions and reminders on how to use ASCENT. Wave 2 recruitment began (n = 8) on January 6, 2025, and has resulted in the recruitment of 5 additional participants. As of April 3, 2025, a total of 13 participants have enrolled in the study. Recruitment of 3 additional participants is ongoing.

Analysis plan

Participant characteristics, metrics of feasibility and acceptability of study procedures and ASCENT, and usability of and engagement with ASCENT will be summarized using descriptive statistics. Transcriptions of exit interviews will undergo rapid qualitative analysis using the RADaR technique [54]. These analyses will aim to characterize potential reasons for the sub-optimal acceptability of aspects of study and intervention delivery procedures.

Discussion

This study aims to assess the feasibility and acceptability of the study procedures, which will inform the design and implementation of a full factorial trial. This pilot phase will focus on evaluating the recruitment, data collection, and retention methods to ensure they are effective and well-received by participants. Following the completion of the pilot study, findings will be used to inform modifications to the protocol for a multi-site full factorial trial. Recruitment will occur through both ECU Health and Wake Forest Baptist Comprehensive Cancer Center. This subsequent trial will evaluate the efficacy of different intervention components and their interactions, ultimately informing the development of an optimized intervention ready for efficacy testing in a randomized controlled trial.

Abbreviations

AYACS

Adolescent and young adult cancer survivors

ASCENT

AYA Survivors Coping and Emotional Needs Toolkit

EMPOWER

Enhancing Management of Psychological Outcomes With Emotion Regulation

CBT

Cognitive behavioral therapy

tCBT

Technology-assisted CBT

HIPAA

Health Insurance Portability and Accountability Act

MYTH

Mind Your Total Health

MOST

Multiphase Optimization Strategy

TLS

Transport Layer Security

REDCap

Research Electronic Data Capture

PHQ-9

Patient Health Questionnaire-9

Appendix

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov; NCT06420193
Date of registration	May 17, 2024
Secondary identifying numbers	23-001795, R00CA248701
Source of monetary or material support	National Cancer Institute
Primary sponsor	National Cancer Institute
Contact for public queries	KMI, PhD[murphykar22@ecu.edu]
Contact for scientific queries	KMI, PhD[murphykar22@ecu.edu]
Public title	Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
Scientific title	Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
Countries of recruitment	USA
Health condition(s) or problem(s) studied	Depression, cancer, adolescent, young adult, adult
Interventions	AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
Key inclusion and exclusion criteria	Inclusion criteria: • Age at enrollment (adolescents 15–17, emerging adults 18–25, young adults 26–39) • Age at diagnosis (adolescents 12–17, emerging adults 15–25, young adults 15–39) • Time since completion of treatment: 1 month to 5 years • Language: fluent in English (spoken and written) • Technology: own smartphone with data plan Exclusion criteria: • Mental health: current diagnosis of severe or persistent mental illness • Suicidality: severe suicidal ideation (including plan and intent)
Study type	Randomized pilot
Recruitment status	Recruiting
Primary outcome(s)	Acceptability of study procedures
Key secondary outcomes	Study feasibility, intervention acceptability, intervention satisfaction, intervention usability (system usability scale), intervention adherence, intervention engagement (eHealth engagement scale)

Authors’ contributions

KMI designed the pilot trial with support from DV and JMS. KMI collaborated with RG, AA, DY, DV, and JMS to design ASCENT. KMI, RG, LW, AC, and RA developed and refined detailed study procedures. AMS informed the statistical analysis. KMI, RG, and LW drafted the manuscript and received substantive feedback from all authors.

Funding

Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number R00CA248701. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

Data availability

Anonymized data from consenting participants will be stored in an open data repository (OSF).

Ethics approval and consent to participate

Institutional ethics approval for this study was obtained from East Carolina University’s University & Medical Center Institutional Review Board #UMCIRB 23-001795, and the trial has been prospectively registered (NCT06420193). Informed consent will be obtained from all participants involved in the study via REDCap. Any important protocol modifications will be submitted to the UMCIRB for approval before being implemented by study staff. If necessary, trial participants will be informed of these changes via e-mail and/or phone.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.