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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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=48) 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Indiana
Indiana University - Indianapolis
RECRUITING
Indianapolis
Contact Information
Primary
Shelley A. Johns, PsyD
sheljohn@iu.edu
317-362-3077
Backup
Jennifer R. West, PhD
jenrwest@regenstrief.org
317-274-9422
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2026-03-05
Participants
Target number of participants: 48
Treatments
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).
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.
Related Therapeutic Areas
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov