36 Participants Needed

Parent Fear of Recurrence Therapy for Cancer Anxiety

(Parent-FORT Trial)

CH
SL
Overseen BySophie Lebel, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Ottawa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Parent Fear of Recurrence Therapy (Parent-FORT), designed to help parents manage the fear of their child's cancer returning. Many parents of childhood cancer survivors experience high anxiety about recurrence, which can reduce their quality of life. The study will compare parents who receive the therapy immediately with those who wait three months to determine the therapy's effectiveness and reception. Suitable candidates are parents living in Canada who care for a child cancer survivor and experience significant anxiety about the cancer returning. As an unphased trial, this study provides parents the chance to access innovative support strategies and contribute to valuable research.

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 is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that this therapy is safe for parents of childhood cancer survivors?

Research shows that Parent Fear of Recurrence Therapy (Parent-FORT) is generally safe for participants. This therapy involves group sessions that include relaxation exercises and cognitive-behavioral therapy (CBT), both proven methods for managing anxiety and stress.

In other studies, similar therapies have been well-received, with participants often reporting satisfaction and benefits from the sessions. No major negative effects have been reported, suggesting that Parent-FORT is likely a safe choice for parents concerned about cancer recurrence.

This pilot study aims to assess the practicality and acceptability of Parent-FORT. Similar programs have been tested successfully in other groups, demonstrating positive results with minimal risks.12345

Why are researchers excited about this trial?

Researchers are excited about Parent Fear of Recurrence Therapy (Parent-FORT) because it's a specialized approach that targets the unique anxiety parents face about their child's cancer returning. Unlike standard treatments that often focus purely on the patient's mental health, this therapy provides tailored psychoeducation for parents, combining relaxation techniques and cognitive-behavioral therapy to directly address their specific fears. This method not only helps reduce anxiety but also equips parents with practical strategies to manage their worries effectively, filling a crucial gap in current mental health care for families dealing with cancer.

What evidence suggests that Parent-FORT might be an effective treatment for fear of cancer recurrence?

Research has shown that Fear of Cancer Recurrence Therapy (FORT) can reduce fear in cancer patients. One study found that FORT significantly lowered the fear of cancer returning, both immediately after treatment and three months later. This therapy includes group sessions, relaxation exercises, and techniques to change negative thinking. In this trial, participants will receive a version of this therapy called Parent Fear of Recurrence Therapy (Parent-FORT), specifically adapted for parents of children who have survived cancer. While FORT primarily targets cancer patients, it might also benefit family caregivers, who often experience equal or greater fear. This adaptation for parents is a promising idea being tested in this study.14678

Who Is on the Research Team?

SL

Sophie Lebel, PhD

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

This trial is for parents of childhood cancer survivors who are experiencing high levels of fear that the cancer will come back. It's designed to see if a special therapy can help them feel better and improve their quality of life. Parents must be able to attend sessions and fill out questionnaires.

Inclusion Criteria

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
See 1 more

Exclusion Criteria

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual or in-person)

Pre-therapy Meeting

One-on-one meeting with a study therapist to prepare participants for group work

1 week
1 visit (virtual)

Treatment

Participants receive 7 weekly group therapy sessions of Parent-FORT intervention

7 weeks
7 visits (virtual)

Follow-up

Participants are monitored for changes in fear of cancer recurrence and quality of life

3 months
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Parent Fear of Recurrence Therapy (Parent-FORT)
Trial Overview The study tests Parent-FORT, an adaptation of Fear of Recurrence Therapy, specifically for these parents. They'll either start therapy right away or after a three-month wait, chosen randomly. The goal is to check if this approach works well (feasible) and if parents like it (acceptable).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CBT/Existential Group Therapy for Fear of Cancer RecurrenceExperimental Treatment1 Intervention
Group II: Waitlist Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials
231
Recruited
267,000+

Children's Hospital of Eastern Ontario

Collaborator

Trials
134
Recruited
61,000+

Alberta Children's Hospital

Collaborator

Trials
58
Recruited
44,700+

Published Research Related to This Trial

The SWORD-study aims to evaluate the effectiveness of cognitive behaviour therapy (CBT) in reducing fear of cancer recurrence (FCR) among 104 high fearful cancer survivors, with assessments occurring at multiple time points over 15 months.
If successful, this study could provide an evidence-based therapeutic option for managing high FCR, which affects over one third of cancer survivors and is linked to negative health outcomes.
Study protocol of the SWORD-study: a randomised controlled trial comparing combined online and face-to-face cognitive behaviour therapy versus treatment as usual in managing fear of cancer recurrence.van de Wal, MA., Gielissen, MF., Servaes, P., et al.[2022]
The cognitive-existential fear of recurrence therapy (FORT) significantly reduced fear of cancer recurrence (FCR) in breast and gynecological cancer survivors compared to an attention placebo control group, with a medium effect size maintained for three months post-treatment.
Participants in the FORT group also showed improvements in related areas such as coping with FCR triggers, cognitive avoidance, and overall mental health quality of life, suggesting that FORT could be an effective new treatment strategy for managing FCR.
Correction to Maheu et al. (2023).[2023]
The Fear of Cancer Recurrence Inventory-Child version (FCRI-C) and the Parent version (FCRI-P) were successfully adapted for childhood cancer survivors aged 8-18 years, showing strong reliability with internal consistency scores of 0.88 and 0.83, respectively.
Initial validity testing indicated that higher fear of cancer recurrence in both children and parents was linked to greater intolerance of uncertainty and increased health-related behaviors, such as more frequent medical consultations for the child.
Measuring fear of cancer recurrence in survivors of childhood cancer: Development and preliminary validation of the Fear of Cancer Recurrence Inventory (FCRI)-Child and Parent versions.Tutelman, PR., Chambers, CT., Heathcote, LC., et al.[2022]

Citations

Parent Fear of Recurrence Therapy for Cancer AnxietyClinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, ...
It is time to address fear of cancer recurrence in family ...Studies suggest that family caregivers of cancer patients experience equal or greater levels of FCR than patients themselves.
Fear of Cancer Recurrence in Adult Survivors of Childhood ...Fear of cancer recurrence and adverse cancer treatment outcomes: predicting 2- to 5-year fear of recurrence from post-treatment symptoms and ...
Fear of cancer recurrence therapy (FORT) - APA PsycNetThis RCT demonstrated that FORT, compared to an attention placebo control group, resulted in a greater reduction in FCR posttreatment and at 3 months ...
The Relational Experience of Fear of Cancer Recurrence ...Fear of cancer recurrence (FCR) affects approximately 50% of family caregivers. While FCR in cancer patients has been well-documented, less is known about ...
It is Time to Address Fear of Cancer Recurrence in Family ...This study aimed to pilot test the adapted Family Caregiver—Fear Of Recurrence Therapy (FC‐FORT) to establish its feasibility, acceptability, ...
What is the prevalence of fear of cancer recurrence in ...A recent meta‐analysis of FCRI results found that 53.9% of cancer survivors and patients scored above the ≥13 cut‐off, 43.3% above the ≥16 cut‐off, and 30% ...
Adapting the Fear of Recurrence Therapy (FORT) for ...Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater ...
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