Parent Fear of Recurrence Therapy for Cancer Anxiety

(Parent-FORT Trial)

Overseen By Sophie Lebel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Ottawa

Disqualifiers: Child 18+, Transplant complications, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 7 weeks

36 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Parent Fear of Recurrence Therapy (Parent-FORT) for cancer anxiety?

Research on similar treatments, like cognitive behavior therapy (CBT) and the Fear-Less program, shows they can help reduce fear of cancer recurrence, suggesting that Parent-FORT might also be effective in managing cancer anxiety. ^{1 2 3 4 5}

How is Parent Fear of Recurrence Therapy (Parent-FORT) different from other treatments for cancer anxiety?

Parent Fear of Recurrence Therapy (Parent-FORT) is unique because it specifically targets the anxiety parents feel about their child's cancer returning, which is a distinct psychological challenge compared to general cancer anxiety treatments. Unlike standard treatments, Parent-FORT may incorporate elements of cognitive behavior therapy (CBT) tailored to address the specific fears and concerns of parents, providing a more focused approach to managing this type of anxiety. ^{1 4 6 7 8}

What is the purpose of this trial?

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.

Research Team

Sophie Lebel, PhD

Principal Investigator

University of Ottawa

Eligibility Criteria

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

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

Timeline

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)

Treatment Details

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).

Participant Groups

Group I: CBT/Existential Group Therapy for Fear of Cancer Recurrence Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Group Active Control 1 Intervention

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

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to Maheu et al. (2023). [2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fear of Cancer Recurrence: A Practical Guide for Clinicians. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Correction to Maheu et al. (2023). [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Fear-Less: A Stepped-Care Program to Manage Fear of Cancer Recurrence in People with Metastatic Melanoma. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Factors reported to influence fear of recurrence in cancer patients: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A systematic mixed studies review of fear of cancer recurrence in families and caregivers of adults diagnosed with cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Fear of Cancer Recurrence and its Predictive Factors among Iranian Cancer Patients. [2021]