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

Running, not enrolling · Not applicable

Conditions studied: Testicular Cancer

In brief

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.

Key facts

Study ID

NCT07228637

Run by

Indiana University

People needed

70

Starts

2025-08-18

Expected to finish

2026-07-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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