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The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients

The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients: study protocol for the EMPOWER-Cancer-Grief RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12141154
Enrollment
50
Registered
2024-12-04
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bereaved caregivers of cancer patients Other

Interventions

The study will consist of two phases. Phase 1 will involve two steps: an open trial with 10 bereaved caregivers who will receive the intervention and then provide feedback on their experience
and a manual refinement process that will involve 5 caregivers and 5 mental health clinicians. They will be provided with the manual and asked for feedback on the content, format, and language of the

Sponsors

European University Cyprus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Having lost a loved one within the last 18 months and three months have passed since the loss 2. Cancer-related loss 3. Aged from 18 years 4. Being at risk for Prolonged Grief based on the PG-13-R scores (Prolonged Grief Disorder Revised; Prigerson et al.,2021) and on the TRIG scores (Texas Revised Inventory of Grief Greek version; Christodoulou et al. under preparation) 5. Able to communicate fluently in Greek.

Exclusion criteria

Exclusion criteria: 1. Having lost a non-adult son/daughter to cancer 2. Low grief risk based on PG-13-R scores and TRIG scores 3. Suffering from severe mental illness (i.e. psychosis, bipolar, severe depression, personality disorder) or substance abuse disorder, or dementia (self-report of previous diagnosis) 4. Substantial risk of suicidality (Based on SRS Suicide Risk Scale; Plutchik et al, 1989) 5. Receiving external psychological support in individual or group format

Design outcomes

Primary

MeasureTime frame
1. Demographics are measured using an ad-hoc questionnaire at Screening, pre-intervention 2. Grief is measured using the Texas Revised Inventory of Grief (TRIG) at Screening, pre-intervention, post-intervention, one-month follow-up, and three-month follow-up 3. Prolonged grief is measured using the Prolonged Grief/PG-13 (Prigerson et al., 2009) at Screening, pre-intervention, post-intervention, one-month follow-up, and three-month follow-up 4. Suicide risk is measured using the Suicide Risk Scale (SRS) at Screening 5. Depression and anxiety are measured using the Depression-Anxiety-Stress Scale (DASS-21) at pre-intervention, post-intervention, one-month follow-up, and three-month follow-up 6. Resilience is measured using the CD-RISC (Connor & Davidson, 2003) at pre-intervention, post-intervention, one-month follow-up, and three-month follow-up 7. Post-traumatic growth is measured using the PTGI (Tedeschi & Calhoun, 1996) at pre-intervention, post-intervention, one-month follow-up, and three-month follow-up 8. Experiential avoidance is measured using the AAQ II (Bond et al., 2011) at pre-intervention, post-intervention, one-month follow-up, and three-month follow-up

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Cyprus

Contacts

Public ContactEleni Petkari
epetkari@uma.es+357 22 713000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026