Pursuing Exploration Into the Supportive Care Needs and Intervention Preferences of Survivors of Testicular Cancer (PERSIST)

February 5, 2026 updated by: Shelley Johns, Indiana University

Pursuing Exploration Into the Supportive Care Needs and Intervention Preferences of Survivors of Testicular Cancer (PERSIST): A Mixed Methods Pilot Study

This trial tests the impact of an Acceptance and Commitment Therapy (ACT)-based coaching program delivered via videoconferencing on fear of cancer recurrence (primary outcome), anxiety, other symptoms, health-related quality of life, and coping (secondary outcomes) in survivors of testicular cancer. ACT includes experiential training in present moment awareness (e.g., mindfulness meditation, performing activities with greater awareness), coping adaptively with difficult internal experiences (e.g., thoughts, feelings, body sensation), identifying personally meaningful values, and pursuing activities consistent with these values. Testicular cancer survivors (N=70) will be randomly assigned in equal numbers to either an ACT-based coaching program or an education/support coaching program, both delivered via videoconferencing. Survivors in both conditions will participate in six weekly 90-minute online group sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial evaluates the feasibility, acceptability, and preliminary efficacy of an Acceptance and Commitment Therapy (ACT)-based coaching program delivered via videoconferencing on fear of cancer recurrence (primary outcome), anxiety, other symptoms, health-related quality of life, and coping (secondary outcomes) in survivors of testicular cancer. The study team is recruiting testicular cancer survivors who have received care at the Indiana University Simon Comprehensive Cancer Center. Potentially eligible patients will be mailed an introductory letter signed by their oncologist and the PI along with a consent form and study flyer. The letter has a number to call if they did not wish to be contacted further. A research assistant (RA) will call all prospective participants who do not opt out approximately 1 week after the letter was mailed. The RA will describe the study as outlined in the consent form and answer any questions. Then the RA will administer an eligibility screening to interested patients. Eligible and interested patients will provide verbal consent before completing a baseline assessment online. Following baseline assessments, patients (N = 70) will be randomly assigned in equal numbers to the ACT-based coaching program or an education/support coaching program using a stratified block randomization scheme to balance the groups by patient-reported time since treatment (last testicular cancer treatment was less than 2 years ago vs. last testicular cancer treatment was 2-5 years ago). Patients in both study conditions will complete six weekly 90-minute group sessions via videoconferencing, with the first session occurring within three weeks of baseline. For both conditions, participants will log their adherence to home practice assignments between sessions. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (quantitative and qualitative).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shelley A. Johns, PsyD
  • Phone Number: 317-362-3077
  • Email: sheljohn@iu.edu

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University - Indianapolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosed with testicular cancer (any type, stage, or risk category) without evidence of active distant disease at time of study entry
  • Completed surgery, chemotherapy, radiation therapy, and/or stem cell transplant 5 years or less prior to enrollment
  • Willing to provide authorization to be contacted by email
  • Willing to complete surveys
  • Willing to participate in six, 90-minute intervention sessions
  • Able to speak and read English
  • Has clinically significant fear of cancer recurrence (FCR-4 score = 9 or higher) and/or anxiety (GAD-2 score = 3 or higher) at eligibility screening

Exclusion Criteria:

  • Completed surgery, chemotherapy, radiation therapy, and/or stem cell transplant less than 2 weeks prior to enrollment (excluding to avoid acute toxicity side effects of treatment)

  • Patient has co-morbidities or deficits that would impair participation in the study, including:

    1. history of neurological disorder or traumatic brain injury (e.g., stroke, encephalitis, epilepsy, loss of consciousness greater than 10 minutes);
    2. severe depressive symptoms (PHQ-2 score = 5 or higher at screening),
    3. active substance abuse or uncontrolled bipolar disorder, schizophrenia, or psychosis;
    4. obvious hearing and/or communicative disability that would impair their participation
  • Patient is currently participating in "The Platinum Study" (PI: Lois Travis)
  • Currently participating in psychotherapy focused on cancer-specific adjustment/support
  • Currently participating in any behavioral/psychosocial research study that has the potential to skew results of this study or the study in which the survivor is participating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coaching Program 1: Acceptance and Commitment Therapy (ACT)
Testicular cancer survivors in the ACT-based coaching arm will learn new and more adaptive ways to respond to fear of cancer recurrence and other difficult internal experiences (e.g., thoughts, feelings, body sensations).
Behavioral: Acceptance and Commitment Therapy (ACT) Coaching
Across six weekly 90-minute online group sessions, testicular cancer survivors in the ACT coaching arm will practice various mindfulness exercises, clarify their values, and set specific values-based action goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to fear of cancer recurrence and other difficult internal experiences (e.g., thoughts, feelings, body sensations). Participants receive handouts on session topics and a link to guided mindfulness practices developed by our team. Participants will be asked to track their home practices on provided logs.
Active Comparator: Coaching Program 2: Education and Support
Testicular cancer survivors in the education and support coaching arm will discuss their cancer-related concerns and receive education on supportive services and resources available locally and nationally.
Behavioral: Education and Support Coaching
Across six weekly 90-minute sessions, testicular cancer survivors in the education and support coaching arm are directed to resources for practical support, health information, and contact information for available community and national resources and support. Sessions include an orientation to testicular cancer survivorship and recurrence risks, education regarding common quality-of-life concerns experienced by cancer survivors, and an overview of community and national resources for addressing these concerns. Participants receive handouts summarizing session topics and are asked to review them as homework.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fear of Cancer Recurrence Scale - 7 items (FCR-7)
Time Frame: 2 weeks and 3 months post-intervention
This 7-item measure includes 6 items assessing feelings associated with cancer recurrence and cognitive and behavioral responses to fear of cancer recurrence on 5-point scales (1=not at all to 5=all the time). Question 7 is a single item assessing the extent to which fear of cancer recurrence intrudes on thoughts and activities on a 0-10 scale (0=not at all to 10=a great deal). The 7 items are summed with higher total scores indicating greater fear of cancer recurrence. The total score range is from 6 to 40. This is the primary outcome measure.
2 weeks and 3 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fear of Cancer Recurrence Inventory (FCRI)
Time Frame: 2 weeks and 3 months post-intervention
This 42-item measure includes items assessing fear of cancer recurrence-related triggers (8 items), severity (9 items), psychological distress (4 items), functioning impairment (6 items), insight (3 items), reassurance seeking (3 items), and coping strategies (9 items). Items are rated on 5-point scales (0=never/not at all to 4=all the time/a great deal) to indicate the extent to which participants have felt fearful during the past month. Item #13 is reverse-scored and then the 42 items are summed with higher total scores indicating greater fear of cancer recurrence. The total score range is 0 to 168. This is a secondary outcome measure.
2 weeks and 3 months post-intervention
Fear of Cancer Recurrence Global Improvement
Time Frame: 2 weeks and 3 months post-intervention
This retrospective global rating of improvement in fear of cancer recurrence provides a patient-centered approach to assessing change that is clinically meaningful. At each post-intervention time points, participants are asked, "Overall, since starting the study program, would you say that your fear of recurrence is: worse, about the same, or better?" Those reporting their fear of cancer recurrence as "better" are then asked if their fear is "a little better, somewhat better, moderately better, a lot better, or completely better." Responses are coded on a 7-point scale such that 0=worse, 1=about the same, 2=a little better, 3=somewhat better, 4=moderately better, 5=a lot better, and 6=completely better, with a higher score indicating greater improvement in fear of cancer recurrence since starting the study program to which they were randomly assigned. This is a secondary outcome measure.
2 weeks and 3 months post-intervention
Generalized Anxiety Disorder Scale - 7 items (GAD-7)
Time Frame: 2 weeks and 3 months post-intervention
Seven items are rated on 4-point scales (0=not at all to 3=nearly every day) to indicate how often in the past 2 weeks participants have been bothered by symptoms of anxiety. The 7 items are summed with higher total scores indicating greater anxiety. The total score range is 0 to 21. This is a secondary outcome measure.
2 weeks and 3 months post-intervention
Patient Health Questionnaire - 8 items (PHQ-8)
Time Frame: 2 weeks and 3 months post-intervention
Seven items are rated on 4-point scales (0=not at all to 3=nearly every day) to indicate how often in the past 2 weeks participants have been bothered by symptoms of anxiety. The 7 items are summed with higher total scores indicating greater anxiety. The total score range is 0 to 21. This is a secondary outcome measure.
2 weeks and 3 months post-intervention
Impact of Events Scale-Revised (IES-R)
Time Frame: 2 weeks and 3 months post-intervention
Twenty-two items are rated on 5-point scales (0=not at all to 4=extremely) to indicate how often in the past 7 days participants have been bothered by post-traumatic stress symptoms, including experiences of intrusion, avoidance, and hyperarousal. The 22 items are summed with higher total scores indicating greater post-traumatic stress. The total score range is 0 to 88. This is a secondary outcome measure.
2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Time Frame: 2 weeks and 3 months post-intervention
This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse scored. Two additional items are reverse scored. Four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure.
2 weeks and 3 months post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (4a)
Time Frame: 2 weeks and 3 months post-intervention
This 4-item measure assesses the perceived interference of pain with functioning in several life domains in the past 7 days. Each item is rated on a 5-point scale (1=not at all to 5=very much). The 4 items are summed with higher total scores indicating greater pain-related interference. The total scores are converted to T-scores with a range from 41.6 to 75.6. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10.
2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (4a)
Time Frame: 2 weeks and 3 months post-intervention
This 4-item measure assesses perceived fatigue severity in the past 7 days. Each item is rated on a 5-point scale (1=not at all to 5=very much). The 4 items are summed with higher total scores indicating greater fatigue severity. The total scores are converted to T-scores with a range from 33.7 to 75.8. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10.
2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (4a)
Time Frame: 2 weeks and 3 months post-intervention
This 4-item measure assesses perceived sleep disturbance in the past 7 days. Each item is rated on a 5-point scale (1=not at all/very good to 5=very much/very poor). Two items (Sleep109, Sleep116) are reverse scored. The 4 items are summed with higher total scores indicating greater sleep disturbance. The total scores are converted to T-scores with a range from 32.0 to 73.3. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10.
2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function (4a)
Time Frame: 2 weeks and 3 months post-intervention
This 4-item measure assesses perceived cognitive functioning in the past 7 days. Each item is rated on a 5-point scale (1=very often/several times a day to 5=never). The 4 items are summed with higher total scores indicating better cognitive functioning. The total scores are converted to T-scores with a range from 24.99 to 61.13. Higher T-scores indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10.
2 weeks and 3 months post-intervention
Multidimensional Psychological Flexibility Inventory (MPFI)
Time Frame: 2 weeks and 3 months post-intervention
Thirty-five items from the Multidimensional Psychological Flexibility Inventory are being used to assess one aspect of psychological flexibility (i.e., acceptance; 5 items) and six aspects of psychological inflexibility (i.e., experiential avoidance, cognitive fusion, lack of contact with the present moment, attachment to the conceptualized self, lack of values clarity, and inaction; 30 items total). Across items, participants rate their behavior on 6-point scales from 1=never true to 6=always true. Separate mean scores across the 5 acceptance items and the 30 psychological inflexibility items are calculated, with mean scores ranging from 1 to 6 on each. Higher mean scores reflect greater acceptance and psychological inflexibility, respectively.
2 weeks and 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shelley A. Johns, PsyD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.

IPD Sharing Time Frame

The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.

IPD Sharing Access Criteria

The data set and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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