NCT01517945进行中（未招募）不适用
Attention and Interpretation Modification (AIM) for Fear of Cancer Recurrence: An Intervention Development Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Develop and refine materials (iThrive and iTrack)
研究概览
简要总结
The purpose of this study is to test, customize, and personalize a mobile app-based intervention program in order to help rare and breast cancer survivors cope with fears of cancer recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phases 1 & 2:
- •Breast cancer survivors
- •Hx of early-stage breast cancer (DCIS and Stages I, II and III)as recorded in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK.
- •≥ 3 months post completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at MSK, self- report or by outside correspondence
- •Age 18 or older
- •Able to read and speak English
- •An overall fear index score of ≥ 3.0 on the CARS
- •If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by reports in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
- •If in non-CBT psychotherapy, stable for at least 8 weeks
- •Access to a computer or willingness to come to MSK to complete intervention sessions 2-8 and the 3-month follow-up assessment, if no personal computer.
- •For Part 2 only, did not participate in Part 1
- •Phase 3, Part 1 and 2:
- •Hx of early-stage breast cancer (DCIS and Stages I, II, and III) as recorded in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
- •Completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at MSK, by self-report, or by outside correspondence
- •Age 18 or older
- •English fluency: self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- •Score of >/= 12 on the 8-item Cancer Worry Scale
- •Score of >/= 2 SDs below the mean on the euro-QOL-Short Form
- •Uses an iOS mobile device (may be an iPad)
- •If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by reports in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK.
- •Phase 3, Part 3:
- •Hx of early-stage breast cancer (DCIS and Stages I, II, and III) with no history of metastasis as per EMR, by self-report, or by outside correspondence.
- •Completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen, or on maintenance medication) as per the EMR or self-report.
- •Age 18 or older as per the EMR or self-report.
- •English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well"
- •Score ≥ 9 on the 6-item Cancer Worry Scale (CWS: this score was found to be optimal to screen for high FCR across cancer types)
- •Score of > 2 SDs below the mean on the Neuro-QOL-Short Form
- •Uses an iOS mobile device (may be an iPad) as per self-report.
- •If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence including a study checklist signed by a physician for patients outside of MSK
- •Must reside in the United States.
- •Phase 4, Parts 2 and 3:
- •Hx of early stage (Stages 0, I, II, and III) rare melanoma subtypes (e.g., acral, uveal) and skin (excluding keratinocyte cancers, e.g., basal and squamous cell), gynecological, long-term adult, pediatric rare liquid cancer (in remission only) or other rare cancer per the EMR, by self-report, or by outside correspondence.
- •Age 18 or older, as per the EMR or self-report.
- •English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- •Score ≥ 9 on the 6-item Cancer Worry Scale (CWS; this score was found to be optimal to screen for high FCR across cancer types)
- •Score of >2 SDs below the mean on the Neuro-QOL - Short Form
- •Uses an iOS mobile device (may be an iPad) as per self-report.
- •If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
- •Completed active treatment (can be on hormonal therapy or on maintenance medication) as per the EMR or self-report.
- •Must reside in the United States.
排除标准
- •Phases 1 & 2:
- •Evidence of or treatment for a second primary of cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the EMR, by self-report, or by outside correspondence
- •Significant psychiatric or cognitive disturbance sufficient, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment) as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence
- •Current participation in cognitive-behavioral therapy (CBT), as confirmed by either self-report* or the EMR, also targets cognitive biases.
- •Evidence of or treatment for a second primary cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the medical record at MSK, by self-report, or by outside correspondence
- •Metastatic disease
- •Score of </= SDs below the mean on the Neuro-QOL-Short Form or other indicators of significant cognitive impairment of psychiatric disturbance that, in the PI's judgment, precludes participation; and currently receiving cognitive-behavioral therapy.
- •Metastatic disease as per the EMR or self-report.
- •Score of ≤ 2 SDs below mean of the Neuro-QoL- Short Form or other indicators of significant cognitive impairment or psychiatric disturbance that, in the PI's judgment, precludes participation; and currently receiving cognitive-behavioral therapy.
- •Participants will be invited to complete assessments of salivary cortisol and/or EEG as part of Phase 4, Part 3 study activities. Those who decline completion of these assessments will still be eligible to participate in the study.
研究组 & 干预措施
Breast cancer survivors and Rare cancer survivors
This is a Cycle for Survival and Center for Translational Science Center (CTSC)-funded intervention development and pilot clinical trial of a psychosocial intervention to address fear of cancer recurrence in breast cancer survivors (BCS) and rare cancer survivors (RCS). BCS form the largest survivor cohort of any cancer, with approximately 2.5 million living in the United States. About 50 percent of people with cancer have a rare cancer. Even though they account for about half of all cancer diagnoses when combined, research aimed at supporting RCS is sparse, leaving RCS with limited support after treatment.
干预措施: AIM materials and assessments (Behavioral)
结局指标
主要结局
Develop and refine materials (iThrive and iTrack)
时间窗: 1 year
This will involve development of a mobile app-based intervention program (based on our results from Phase 1 and 2 and preliminary work conducted by Beard et al.) that targets fear of cancer recurrence for breast, rare gynecological, rare melanoma and skin, long-term adult pediatric, and other rare cancer survivors.
次要结局
- Determine feasibility, usability, acceptability(1 year)
- Preliminary Efficacy(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Adaptive Interventions for Prevention/Intervention for Youth Substance AbuseSubstance UseNCT03928756University of Michigan39
Unknown
不适用
Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and ConsequencesUse, Problem AlcoholNCT04213846University of Washington408
尚未招募
不适用
RCT Protocol for 'OverThinking': A Mobile EMI for Reducing Experiential AvoidanceRuminationDepressionAnxietyNCT06570694University of Social Sciences and Humanities, Warsaw60
已完成
早期 1 期
Boost Study 21270 (Cognition)Cognitive Function AbnormalNCT05990335NXTech124
已完成
不适用
Depression Return to Work InterventionJob StressDistress, EmotionalNCT06026280Inspiration at Work141