Acceptance and Commitment Therapy for Testicular Cancer Survivors

(PERSIST Trial)

Overseen By Jennifer R. West, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Neurological disorder, Severe depression, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well an online coaching program using Acceptance and Commitment Therapy (ACT) can help testicular cancer survivors manage their fear of recurrence, anxiety, and related challenges. Participants will be divided into two groups: one will engage in ACT, which involves mindfulness and focusing on personal values, while the other will receive general cancer education and support. The trial seeks testicular cancer survivors who completed treatment within the last five years and experience significant fears about cancer returning or anxiety. As an unphased trial, this study provides a unique opportunity for participants to explore innovative support methods and contribute to research that may benefit future cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on therapy sessions and does not mention medication changes.

What prior data suggests that this ACT-based coaching program is safe for testicular cancer survivors?

Research has shown that Acceptance and Commitment Therapy (ACT) is safe and well-received by cancer survivors. Studies have found that ACT reduces anxiety, depression, and the fear of cancer recurrence. It also enhances adaptability and improves overall quality of life. Participants have not reported any major side effects from ACT. The therapy involves learning new ways to manage thoughts and feelings, typically through a gentle and supportive process. This makes ACT a promising and safe option for those considering a clinical trial focused on mental health support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for testicular cancer survivors because it offers a novel approach to managing the fear of cancer recurrence and other challenging emotions. Unlike traditional support methods that primarily focus on education and resource sharing, ACT helps individuals develop skills to adaptively respond to their internal experiences, such as thoughts and feelings. This psychological flexibility can empower survivors to lead more fulfilling lives despite their concerns, making ACT a promising complementary option to existing support and counseling services.

What evidence suggests that Acceptance and Commitment Therapy (ACT) might be an effective treatment for fear of cancer recurrence in testicular cancer survivors?

This trial will compare Acceptance and Commitment Therapy (ACT) with an education and support program for testicular cancer survivors. Studies have shown that ACT can be very helpful for cancer survivors. Research indicates that ACT significantly reduces anxiety and the fear of cancer recurrence. It also improves psychological flexibility, enabling better handling of changes and stress, and enhances overall quality of life. ACT helps individuals focus on the present moment and manage difficult thoughts and feelings. This approach has proven to boost well-being and reduce common psychological symptoms in cancer patients. Overall, evidence supports ACT as a promising method to help testicular cancer survivors cope more effectively. ^{1 2 5 6 7}

Who Is on the Research Team?

Shelley A. Johns, PsyD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for survivors of testicular cancer who have completed their treatment and are experiencing anxiety or fear of cancer recurrence. Participants must be able to attend six weekly 90-minute online sessions and complete assessments at specified times.

Inclusion Criteria

Able to speak and read English

Willing to provide authorization to be contacted by email

I finished my cancer treatment within the last 5 years.

Exclusion Criteria

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

Patient has co-morbidities or deficits that would impair participation in the study including: history of neurological disorder or traumatic brain injury, severe depressive symptoms, active substance abuse or uncontrolled bipolar disorder, schizophrenia, or psychosis, obvious hearing and/or communicative disability

Patient is currently participating in 'The Platinum Study' (PI: Lois Travis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Baseline Assessment

Eligible participants complete a baseline assessment online

1 week

1 visit (virtual)

Treatment

Participants receive either ACT-based or education/support coaching program via videoconferencing

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy (ACT) Coaching

Trial Overview The study compares two coaching programs delivered via videoconferencing: one based on Acceptance and Commitment Therapy (ACT) focusing on mindfulness, coping skills, values identification, and the other providing education/support. The impact on anxiety, quality of life, symptoms, and coping will be measured.

How Is the Trial Designed?

Group I: Coaching Program 1: Acceptance and Commitment Therapy (ACT) Experimental Treatment 1 Intervention

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).

Group II: Coaching Program 2: Education and Support Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960234/

Acceptance and commitment therapy in adult cancer survivors ACT significantly reduced anxiety, depression, and fear of cancer recurrence and improved psychological flexibility and quality of life.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07228637?cond=cancer&aggFilters=status%3Arec

Pursuing Exploration Into the Supportive Care Needs and ... This trial evaluates the feasibility, acceptability, and preliminary efficacy of an Acceptance and Commitment Therapy (ACT)-based coaching ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212144724000930

Truce: Outcomes and mechanisms of change of a seven ... Truce is a new ACT-based program for young people impacted by parental cancer. This pragmatic controlled trial compares program outcomes to a wait-list control.

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/21582440241297591

Internet-delivered Acceptance and Commitment Therapy ... Acceptance and commitment therapy (ACT) has proven effective in cancer patients, reducing common psychological symptoms and improving wellbeing.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06592-3

study protocol for a randomized controlled trial This study will provide valuable information on the effectiveness of an online self-help intervention based on ACT versus WLC for chronic painful CIPN patients.

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/21582440241297591

Internet-delivered Acceptance and Commitment Therapy ... Acceptance and commitment therapy (ACT) has proven effective in cancer patients, reducing common psychological symptoms and improving ...

7. researchgate.net researchgate.net/publication/323887486_Acceptance_and_Commitment_Therapy_in_Cancer_Review_of_Applications_and_Findings

(PDF) Acceptance and Commitment Therapy in Cancer This study aimed to analyse published studies regarding the usefulness of Acceptance and Commitment Therapy in the treatment of oncological patients.