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Testicular CancerPERSISTNCT07228637

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

A study testing Acceptance and Commitment Therapy (ACT) Coaching and Education and Support Coaching in people with Testicular Cancer, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, men only
Conditions the study is for
Testicular Cancer
What is being tested?
Acceptance and Commitment Therapy (ACT) Coaching and Education and Support Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
18 Aug 2025to 3 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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:
  • history of neurological disorder or traumatic brain injury (e.g., stroke, encephalitis, epilepsy, loss of consciousness greater than 10 minutes);
  • severe depressive symptoms (PHQ-2 score = 5 or higher at screening),
  • active substance abuse or uncontrolled bipolar disorder, schizophrenia, or psychosis;
  • obvious hearing and/or communicative disability that would impair their participation
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University - Indianapolis

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Acceptance and Commitment Therapy (ACT) Coaching, Education and Support Coaching
Keywords
Fear of Cancer Recurrence, Anxiety, Acceptance and Commitment Therapy, Supportive Care Needs
Medical subject headings
Testicular Neoplasms, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT) CoachingBehavioural

    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.

  • Education and Support CoachingBehavioural

    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.

Study groups in NCT07228637
Study groupRoleWhat they receive
Coaching Program 1: Acceptance and Commitment Therapy (ACT)ExperimentalTesticular 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).
Receives: Behavioral: Acceptance and Commitment Therapy (ACT) Coaching
Coaching Program 2: Education and SupportActive comparatorTesticular 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.
Receives: Behavioral: Education and Support Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of Cancer Recurrence Scale - 7 items (FCR-7)

    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.

    Measured: 2 weeks and 3 months post-intervention

Secondary outcomes (6)

  1. Fear of Cancer Recurrence Inventory (FCRI)

    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.

    Measured: 2 weeks and 3 months post-intervention

  2. Fear of Cancer Recurrence Global Improvement

    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.

    Measured: 2 weeks and 3 months post-intervention

  3. Generalized Anxiety Disorder Scale - 7 items (GAD-7)

    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.

    Measured: 2 weeks and 3 months post-intervention

  4. Patient Health Questionnaire - 8 items (PHQ-8)

    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.

    Measured: 2 weeks and 3 months post-intervention

  5. Impact of Events Scale-Revised (IES-R)

    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.

    Measured: 2 weeks and 3 months post-intervention

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health

    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.

    Measured: 2 weeks and 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start18 Aug 2025
  3. Primary completion3 Jun 2026
  4. Study completion3 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants (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 completion (last testicular cancer treatment was less than 2 years ago vs. last testicular cancer treatment was 2-5 years ago).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07228637
Sponsor's protocol ID
22340
Acronym
PERSIST
Status last verified
Oct 2026
First submitted
13 Nov 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) Coaching and Education and Support Coaching in people with Testicular Cancer, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Cancer Recurrence Scale - 7 items (FCR-7) (time frame: 2 weeks and 3 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07228637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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