Pursuing Exploration Into the Supportive Care Needs and Intervention Preferences of Survivors of Testicular Cancer (PERSIST): A Mixed Methods Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fear of Cancer Recurrence Scale - 7 items (FCR-7)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Acceptance and Commitment Therapy (ACT) Coaching (Behavioral)
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.
干预措施: Education and Support Coaching (Behavioral)
结局指标
主要结局
Fear of Cancer Recurrence Scale - 7 items (FCR-7)
时间窗: 2 weeks and 3 months post-intervention
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.
次要结局
- 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)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health(2 weeks and 3 months post-intervention)
研究者
Shelley Johns
Associate Professor of Medicine and Walther Scholar in Psycho-Oncology
Indiana University