Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss
FAM-SOTC-PL
The Effect of Receiving a FAM-SOTC Intervention Before and in the Bereavement Phase (FAM-SOTC-PL) on Bereaved Family Cancer Caregivers Outcomes: A Quasi-experimental Study
1 other identifier
interventional
51
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Typical duration for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedFebruary 21, 2019
December 1, 2018
2.7 years
February 19, 2019
February 20, 2019
Conditions
Keywords
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
EXPERIMENTALGrief responses, levels of vulnerability, measured using the Adult Attitude to Grief scale (AAG), a self-administered questionnaire
Interventions
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.
Eligibility Criteria
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
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