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

NCT07228637 | Active Not Recruiting DMC

• 1 other identifier: 22340
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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=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.

Conditions

Testicular Cancer

Keywords

Fear of Cancer Recurrence; Anxiety; Acceptance and Commitment Therapy; Supportive Care Needs

Outcome Measures

Primary Outcomes (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.

  2 weeks and 3 months post-intervention

Secondary Outcomes (6)

• Fear of Cancer Recurrence Inventory (FCRI)

  2 weeks and 3 months post-intervention

• Fear of Cancer Recurrence Global Improvement

  2 weeks and 3 months post-intervention

• Generalized Anxiety Disorder Scale - 7 items (GAD-7)

  2 weeks and 3 months post-intervention

• Patient Health Questionnaire - 8 items (PHQ-8)

  2 weeks and 3 months post-intervention

• Impact of Events Scale-Revised (IES-R)

  2 weeks and 3 months post-intervention

Other Outcomes (5)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (4a)

  2 weeks and 3 months post-intervention

• Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (4a)

  2 weeks and 3 months post-intervention

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (4a)

  2 weeks and 3 months post-intervention

Study Arms (2)

Coaching Program 1: Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

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

Coaching Program 2: Education and Support

ACTIVE COMPARATOR

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

Interventions

Education and Support Coaching BEHAVIORAL

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.

Coaching Program 2: Education and Support

Acceptance and Commitment Therapy (ACT) Coaching BEHAVIORAL

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.

Coaching Program 1: Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms; Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Shelley A. Johns, PsyD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Walther Scholar in Psycho-Oncology

Model Details: 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).

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)