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Testing Parent Fear of Recurrence Therapy for cancer

Official title: Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility

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

Condition: CancerSponsor: University of OttawaTarget enrollment: 36
  • 2 groups
  • One site, in Ottawa
  • Recruiting
University of Ottawa, Ottawa, Ontario

Interventions

  • Behavioural therapy

    Parent Fear of Recurrence Therapy (Parent-FORT)

    7 weekly sessions of 120 minutes each. During the 7 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework assignments.

Canadian Sites (1)

1 of 1 recruiting

  • University of Ottawa

    Ottawa, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for10 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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
  • +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
  • +Access to a computer and internet connection
  • +Living in Canada

Exclusion

  • 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.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Parent Fear of Recurrence Therapy (Parent-FORT).

Registry label: A: CBT/Existential Group Therapy for Fear of Cancer Recurrence

Group B receives no study treatment and is followed for comparison.

Registry label: B: Waitlist Control Group

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 36 people.

The study is currently expected to finish around May 2027.

The main measurement is taken over: Changes in baselineBaselineYour starting measurements, taken before treatment begins.Read more → fear of cancer recurrence 7 weeks after the start of the intervention.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Changes in baselineBaselineYour starting measurements, taken before treatment begins.Read more → fear of cancer recurrence after intervention — measured over Changes in baseline fear of cancer recurrence 7 weeks after the start of the intervention.

Changes in baseline fear of cancer recurrence at three months — measured over Changes in baseline fear of cancer recurrence 3 months after the start of the intervention.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06872840 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Parent Fear of Recurrence Therapy (Parent-FORT)Behavioural

7 weekly sessions of 120 minutes each. During the 7 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework assignments.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Changes in baselineBaselineYour starting measurements, taken before treatment begins.Read more → fear of cancer recurrence 7 weeks after the start of the intervention.

The study as a whole is currently expected to finish around 2027-05-26.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 36 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Ottawa, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About 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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.