NCT05518591

Brief Summary

The purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 24, 2022

Last Update Submit

August 24, 2022

Conditions

Psychological DistressCancer Recurrence

Outcome Measures

Primary Outcomes (1)

  • Overall Distress Score

    The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)

    12 weeks post completion of intervention

Secondary Outcomes (4)

  • Changes in depressive symptoms

    12 weeks post completion of intervention

  • Changes in anxiety symptoms

    12 weeks post completion of intervention

  • Changes in traumatic distress

    12 weeks post completion of intervention

  • Mental Adjustment to Cancer Recurrence

    12 weeks post completion of intervention

Study Arms (2)

CFT & BPR

EXPERIMENTAL

6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining.

Behavioral: Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)

Treatment As Usual

NO INTERVENTION

Those in the treatment as usual arm are not being asked to engage in anything additional to their regular treatment plan. They will, however, be given the option to participate in the psychological intervention after the study has ended, if they elect to do so.

Interventions

Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)BEHAVIORAL

Study participants in the experimental arm of the study are being asked to take part in a 6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. Each group session lasts less than two hours, per week.

CFT & BPR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults aged 18 or older
  • pre-existing cancer diagnosis
  • diagnosis of cancer recurrence during COVID-19 (March 2020 onwards)
  • Living in Ireland
  • English speaking / fluency
  • Access to web / tech support

You may not qualify if:

  • A score \<4 on the Distress Thermometer
  • Patient non-consent
  • The presence of a severe mental illness (such as schizophrenia, personality disorder or active illness)
  • Known or suspected drug or alcohol abuse problems within past 3 months
  • Inability to follow the study procedures e.g. dementia or non-fluency of English
  • Life expectancy \<3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

  • Lynch S, Lowry D, Finnerty C, O'Meara Y, Brennan D. The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID. Trials. 2023 Feb 6;24(1):89. doi: 10.1186/s13063-023-07088-4.

    PMID: 36747246DERIVED

Study Officials

  • Sinead Lynch, PhD

    MMUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donal Brennan, PhD

CONTACT

01 716 4576donal.brennan@ucd.ie

Sinead Lynch, PhD

CONTACT

087 803 9068SineadLynch@mater.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Donal Brennan

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

March 25, 2022

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)