NCT03850132

Brief Summary

Background and study aims The effect of cancer caregiving may have profound impact on the psychosocial health of family caregivers and become evident after loss. Grief following the loss of a close relative is one of the most emotional challenging experience faced by family caregivers. Providing a family based intervention before and after a close relatives´death may positively impact bereavement outcomes. This study aims to assess the impact of a continuing specific supportive care intervention on bereaved family caregivers grief response scores and psychological distress following the loss of a close relative when offered before and after death because of cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
Last Updated

February 21, 2019

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

February 19, 2019

Last Update Submit

February 20, 2019

Conditions

Keywords

CaregiversCancerPalliative care

Outcome Measures

Primary Outcomes (3)

  • Change in Depression

    The Depression Anxiety Stress Scale - DASS (Lovibond \& Lovibond, 1995) is used. The DASS is a 42-item self-report instrument with 3 sub-scales. Each scale comprises 14 items assessing the negative emotional states of depression, anxiety and stress.

    3, 5, and 6 months

  • Change in Anxiety

    The Depression Anxiety Stress Scale - DASS (Lovibond \& Lovibond, 1995) is used. The DASS is a 42-item self-report instrument with 3 sub-scales. Each scale comprises 14 items assessing the negative emotional states of depression, anxiety and stress.

    3, 5, and 6 months

  • Change in Stress

    The Depression Anxiety Stress Scale - DASS (Lovibond \& Lovibond, 1995) is used. The DASS is a 42-item self-report instrument with 3 sub-scales. Each scale comprises 14 items assessing the negative emotional states of depression, anxiety and stress.

    3, 5, and 6 months

Study Arms (1)

FAM-SOTC-PL

EXPERIMENTAL

Grief responses, levels of vulnerability, measured using the Adult Attitude to Grief scale (AAG), a self-administered questionnaire

Behavioral: FAM-SOTC-PL

Interventions

FAM-SOTC-PLBEHAVIORAL

The adapted FAM-SOTC-PL intervention was delivered at the home of the participants and focuses on supporting the effective, cognitive, and behavioural domains of the bereaved family caregivers experience by targeting concerns/issues in these categories. The FAM-SOTC-PL comprises of the following five components: 1. Drawing forward narratives about the pre- and post-loss experience. 2. Asking therapeutic/interventive questions, emphasising on the most pressing concerns also assessing health issues. 3. Validating/acknowledging emotional responses. 4. Assessing the need for specific information and recommendations regarding bereavement. 5. The use of commendation/commending strengths, by focusing on and affirming the strengths of the family caregiver.

FAM-SOTC-PL

Eligibility Criteria

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

You may not qualify if:

  • Non cancer and not being participating in another family level psycho-social intervention research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

July 27, 2014

Primary Completion

April 20, 2017

Study Completion

April 20, 2017

Last Updated

February 21, 2019

Record last verified: 2018-12