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고환암 생존자의 지원적 돌봄 요구와 중재 선호도에 관한 탐구 (PERSIST)

2026년 10월 2일 업데이트: Shelley Johns, Indiana University

고환암 생존자의 지원 요구와 중재 선호도에 관한 탐색적 연구(PERSIST): 혼합 방법론 파일럿 연구

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.

연구 개요

상세 설명

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).

연구 유형

중재적

등록 (실제)

70

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • Indiana University - Indianapolis

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. history of neurological disorder or traumatic brain injury (e.g., stroke, encephalitis, epilepsy, loss of consciousness greater than 10 minutes);
    2. severe depressive symptoms (PHQ-2 score = 5 or higher at screening),
    3. active substance abuse or uncontrolled bipolar disorder, schizophrenia, or psychosis;
    4. 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).

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.

활성 비교기: 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.

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Fear of Cancer Recurrence Scale - 7 items (FCR-7)
기간: 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.

2 weeks and 3 months post-intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Fear of Cancer Recurrence Inventory (FCRI)
기간: 2 weeks and 3 months post-intervention

This 42-item measure includes items assessing fear of cancer recurrence-related triggers (8 items), severity (9 items), psychological distress (4 items), functioning impairment (6 items), insight (3 items), reassurance seeking (3 items), and coping strategies (9 items). Items are rated on 5-point scales (0=never/not at all to 4=all the time/a great deal) to indicate the extent to which participants have felt fearful during the past month. Item #13 is reverse-scored and then the 42 items are summed with higher total scores indicating greater fear of cancer recurrence. The total score range is 0 to 168. This is a secondary outcome measure.

2 weeks and 3 months post-intervention
Fear of Cancer Recurrence Global Improvement
기간: 2 weeks and 3 months post-intervention

This retrospective global rating of improvement in fear of cancer recurrence provides a patient-centered approach to assessing change that is clinically meaningful. At each post-intervention time points, participants are asked, "Overall, since starting the study program, would you say that your fear of recurrence is: worse, about the same, or better?" Those reporting their fear of cancer recurrence as "better" are then asked if their fear is "a little better, somewhat better, moderately better, a lot better, or completely better." Responses are coded on a 7-point scale such that 0=worse, 1=about the same, 2=a little better, 3=somewhat better, 4=moderately better, 5=a lot better, and 6=completely better, with a higher score indicating greater improvement in fear of cancer recurrence since starting the study program to which they were randomly assigned. This is a secondary outcome measure.

2 weeks and 3 months post-intervention
Generalized Anxiety Disorder Scale - 7 items (GAD-7)
기간: 2 weeks and 3 months post-intervention

Seven items are rated on 4-point scales (0=not at all to 3=nearly every day) to indicate how often in the past 2 weeks participants have been bothered by symptoms of anxiety. The 7 items are summed with higher total scores indicating greater anxiety. The total score range is 0 to 21. This is a secondary outcome measure.

2 weeks and 3 months post-intervention
Patient Health Questionnaire - 8 items (PHQ-8)
기간: 2 weeks and 3 months post-intervention

Seven items are rated on 4-point scales (0=not at all to 3=nearly every day) to indicate how often in the past 2 weeks participants have been bothered by symptoms of anxiety. The 7 items are summed with higher total scores indicating greater anxiety. The total score range is 0 to 21. This is a secondary outcome measure.

2 weeks and 3 months post-intervention
Impact of Events Scale-Revised (IES-R)
기간: 2 weeks and 3 months post-intervention

Twenty-two items are rated on 5-point scales (0=not at all to 4=extremely) to indicate how often in the past 7 days participants have been bothered by post-traumatic stress symptoms, including experiences of intrusion, avoidance, and hyperarousal. The 22 items are summed with higher total scores indicating greater post-traumatic stress. The total score range is 0 to 88. This is a secondary outcome measure.

2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
기간: 2 weeks and 3 months post-intervention

This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse scored. Two additional items are reverse scored. Four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure.

2 weeks and 3 months post-intervention

기타 결과 측정

결과 측정
측정값 설명
기간
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (4a)
기간: 2 weeks and 3 months post-intervention

This 4-item measure assesses the perceived interference of pain with functioning in several life domains in the past 7 days. Each item is rated on a 5-point scale (1=not at all to 5=very much). The 4 items are summed with higher total scores indicating greater pain-related interference. The total scores are converted to T-scores with a range from 41.6 to 75.6. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10.

2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (4a)
기간: 2 weeks and 3 months post-intervention

This 4-item measure assesses perceived fatigue severity in the past 7 days. Each item is rated on a 5-point scale (1=not at all to 5=very much). The 4 items are summed with higher total scores indicating greater fatigue severity. The total scores are converted to T-scores with a range from 33.7 to 75.8. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10.

2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (4a)
기간: 2 weeks and 3 months post-intervention

This 4-item measure assesses perceived sleep disturbance in the past 7 days. Each item is rated on a 5-point scale (1=not at all/very good to 5=very much/very poor). Two items (Sleep109, Sleep116) are reverse scored. The 4 items are summed with higher total scores indicating greater sleep disturbance. The total scores are converted to T-scores with a range from 32.0 to 73.3. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10.

2 weeks and 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function (4a)
기간: 2 weeks and 3 months post-intervention

This 4-item measure assesses perceived cognitive functioning in the past 7 days. Each item is rated on a 5-point scale (1=very often/several times a day to 5=never). The 4 items are summed with higher total scores indicating better cognitive functioning. The total scores are converted to T-scores with a range from 24.99 to 61.13. Higher T-scores indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10.

2 weeks and 3 months post-intervention
Multidimensional Psychological Flexibility Inventory (MPFI)
기간: 2 weeks and 3 months post-intervention

Thirty-five items from the Multidimensional Psychological Flexibility Inventory are being used to assess one aspect of psychological flexibility (i.e., acceptance; 5 items) and six aspects of psychological inflexibility (i.e., experiential avoidance, cognitive fusion, lack of contact with the present moment, attachment to the conceptualized self, lack of values clarity, and inaction; 30 items total). Across items, participants rate their behavior on 6-point scales from 1=never true to 6=always true. Separate mean scores across the 5 acceptance items and the 30 psychological inflexibility items are calculated, with mean scores ranging from 1 to 6 on each. Higher mean scores reflect greater acceptance and psychological inflexibility, respectively.

2 weeks and 3 months post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Shelley A. Johns, PsyD, Indiana University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 18일

기본 완료 (실제)

2026년 6월 3일

연구 완료 (실제)

2026년 6월 3일

연구 등록 날짜

최초 제출

2025년 11월 13일

QC 기준을 충족하는 최초 제출

2025년 11월 13일

처음 게시됨 (실제)

2025년 11월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다