跳至主要内容
临床试验/NCT06872840
NCT06872840招募中不适用

Addressing Fear of Cancer Recurrence in Parents of Pediatric Cancer Survivors: Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility

University of Ottawa1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Changes in baseline fear of cancer recurrence after intervention

研究概览

简要总结

Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, which has been linked to lower quality of life and increased distress. FCR can be addressed in cancer survivors with brief interventions. However, none of these interventions have been tested with parents of childhood cancer survivors. This is an urgent gap: the survival rates of childhood cancer have increased more rapidly than for adult cancers, resulting in a growing population of childhood cancer survivors who, along with their families, need support.

The goals of this pilot study are to demonstrate 1) that a newly adapted intervention of FORT (Parent-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., parent satisfaction of the intervention) for a larger study, and 2) the clinical implications of Parent-FORT on fear of cancer recurrence (FCR) and quality of life in parents of childhood cancer survivors.

Parents will be randomly assigned to participate in the Parent-FORT intervention immediately or a three-month waitlist control group. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. This study will help bridge an important gap in bringing evidence-based care to parents who have never been offered help before for their FCR.

详细描述

Pilot Study:

36 parents will be recruited to participate in the study. Additionally, 3 therapists with extensive online support group experience to conduct the Parent-FORT videoconference therapy sessions. Therapist competency to administer Parent-FORT will be determined by registered professionals in counselling or psychotherapy, experience in psychosocial oncology, specifically with parents, and having led at least one group. Interested parents will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. This pilot study will serve as a first step in potential sample size calculations and recruitment times. For this pilot study, active recruitment will last for a period of 15 months during which 36 parents are aimed to be recruited in order to create 4 groups of 9 participants (2 intervention conditions and 2 WLCG). Feasibility of recruitment for the larger RCT will be determined using these criteria: 1) If during our recruitment period less than 18 participants, recruitment for a larger RCT, using our current recruitment strategies, will be deemed not feasible, 2) If between 18 and 25 participants are recruited, then a larger multicentre approach for recruitment will be considered, 3) If recruit 25 participants or more, recruitment for a larger RCT, using our current methods, will be deemed feasible. The sample size will be reevaluated for the larger RCT based on the results from this pilot study.

Parent-FORT consists of 7 consecutive weekly group sessions of 120 minutes each offered through videoconference and weekly assigned homework. Parent-FORT is therapist led, however participants will receive a workbook where they can follow along, take notes, and complete the exercises and the homework assignments. The overall aim of Parent-FORT is to guide Parent towards a more manageable level of worry and fear of recurrence. The key goals are to: 1) distinguish worrisome symptoms from benign ones; 2) identify FCR triggers and inappropriate coping strategies; 3) facilitate the learning and use of new coping strategies, such as relaxation techniques, cognitive restructuring, communication strategies and the use of self-care; 4) increase tolerance for uncertainty; 5) promote emotional expression of specific fears that underlie FCR; and 6) re-examine life priorities and set realistic goals for the future. Each session is composed of exercises where participants have to answer questions, share with the group or watch videos. Furthermore, homework is assigned after each session to be completed before next week's session. Eligible participants will attend a one-on-one pre-therapy meeting with a study therapist to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week Parent-FORT intervention. Membership will be closed once groups are formed and the sessions have started to enhance group cohesiveness and consistency. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. All participants (including those in the wait list control group) will complete a questionnaire package pre intervention, post intervention, and at a three month follow up via Qualtrics. Additionally, participants will be asked to complete post session measures, namely the Working Alliance Inventory - Revised Short Form as well as the Group Cohesiveness Scale after the 1st, 4th and 7th sessions.

Therapist Training and Supervision:

To enhance therapist adherence to treatment, the therapists recruited for the study will be provided with a standardized Parent-FORT manual and will be trained by the research psychologists through an online training. The research team will review the video of each session, and the principal investigator will provide weekly 30-minute supervision to the therapists. Furthermore, the study will use an updated version of the fidelity checklist that was used to evaluate adherence during the previous FORT studies. If adherence is less than 80% on any session, the research team will provide additional over-the-telephone feedback to the therapists running the group. This approach to monitoring treatment integrity and fidelity has been successful in previous FORT studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • •Parent (or primary caregiver) caring for a childhood cancer survivor (<18 years of age) of any type of cancer type, who is at least 1 months from the completion of active treatment and has not had a recurrence of their cancer
  • •A score of 13 or greater on the Fear of Cancer Recurrence Inventory-Short Form-Parent version (FCRI-SF-P; range 0-36), suggesting clinical levels of FCR
  • •Access to a computer and internet connection
  • •Living in Canada

排除标准

  • •Being the parent of a pediatric cancer survivor who is now 18 years of age or older
  • •Being the parent of a pediatric cancer survivor who has undergone hematopoietic cell transplantation and has active chronic or acute graft-versus-host disease which has not stabilized for at least 3 months
  • •Non-English speakers
  • •Currently participating in another therapist-led psychosocial therapy group
  • •Parent with unmanaged/undermanaged mental health disorder judged to be clinically contraindicated and/or likely to affect the group work
  • •To avoid violating the assumption of nonindependence of the data, only one parent/caregiver per child can participate in the study.

研究组 & 干预措施

CBT/Existential Group Therapy for Fear of Cancer Recurrence

Experimental

Participants will receive 7 weekly group therapy sessions consisting of psychoeducation on fear of cancer recurrence, relaxation training, CBT, and evidenced-based tips to decrease avoidance and anxiety surrounding fear of cancer recurrence.

干预措施: Parent Fear of Recurrence Therapy (Parent-FORT) (Behavioral)

Waitlist Control Group

No Intervention

Participants assigned to this arm will wait about 3-months to receive the intervention.

结局指标

主要结局

Changes in baseline fear of cancer recurrence after intervention

时间窗: Changes in baseline fear of cancer recurrence 7 weeks after the start of the intervention

Fear of Cancer Recurrence Inventory - Parent (FCRI-P), range from 0-36 with higher scores indicating high levels of fear of cancer recurrence

Changes in baseline fear of cancer recurrence at three months

时间窗: Changes in baseline fear of cancer recurrence 3 months after the start of the intervention

Fear of Cancer Recurrence Inventory - Parent (FCRI-P), range from 0-36 with higher scores indicating high levels of fear of cancer recurrence

次要结局

  • Changes in Baseline Intolerance of Uncertainty Scale at 7 Weeks(Changes in baseline Intolerance of Uncertainty Scale after 7 weeks of the intervention)
  • Changes in Baseline Intolerance of Uncertainty Scale at 3 Months(Changes in baseline Intolerance of Uncertainty Scale at 3 month after the completion of the intervention)
  • Changes in baseline Uncertainty in Illness at 7 weeks(Changes in baseline Intolerance of Uncertainty Scale after 7 weeks of the intervention)
  • Changes in baseline Uncertainty in Illness at 3 months(Changes in baseline Intolerance of Uncertainty Scale at 3 month after the completion of the intervention)
  • Changes in baseline Positive Beliefs About Worrying at 7 weeks(Changes in baseline Positive Beliefs About Worrying after 7 weeks of the intervention)
  • Changes in baseline Positive Beliefs About Worrying at 3 months(Changes in baseline Positive Beliefs About Worrying at 3 month after the completion of the intervention)
  • Changes in baseline avoidance at 7 weeks(Changes in baseline avoidance after 7 weeks of the intervention)
  • Changes in baseline avoidance at 3 months(Changes in baseline Avoidance at 3 month after the completion of the intervention)
  • Changes in fear of bodily threat at 7 weeks(Changes in fear of bodily threat after 7 weeks of the intervention)
  • Changes in fear of bodily threat at 3 months(Changes in fear of bodily threat at 3 month after the completion of the intervention)
  • Changes in healthcare utilization at 3 months(Changes in healthcare utilization at 3 month after the completion of the intervention)
  • Changes in quality of life at 7 weeks(Changes in quality of life after 7 weeks of the intervention)
  • Changes in quality of life at 3 months(Changes in quality of life at 3 month after the completion of the intervention)
  • Changes in perceived risk of recurrence at 7 weeks(Changes in perceived risk of recurrence after 7 weeks of the intervention)
  • Changes in perceived risk of recurrence at 3 months(Changes in perceived risk of recurrence 3 month after the completion of the intervention)
  • Measure of acceptability/satisfaction at 7 weeks(Measure of acceptability/satisfaction after 7 weeks of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sophie Lebel

Professor

University of Ottawa

研究点 (1)

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