FAM-SOTC-PL: Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss

Sponsor
University of Iceland (Other)
Overall Status
Completed
CT.gov ID
NCT03850132
Collaborator
(none)
51
1
32.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: FAM-SOTC-PL
N/A

Detailed Description

This clinical trial is part of a broader research study (registered trial intervention ISRCTN21786830) which aimed to evaluate a palliative care nurse-led family-oriented intervention Family-Strengths Oriented Therapeutic Conversation (FAM-SOTC) to support family caregivers of a close relative with advanced/final stage cancer, in the context of the family when receiving specialized palliative home-care. The purpose of the current trial is to investigate the effects of the FAM-SOTC intervention when additionally delivering the third session of the intervention in this trial; an adapted version; FAM-SOTC Post-Loss and repeated post-intervention measures at 3, 5 and six months post-loss completed by bereaved family caregivers who have prior participated in the FAM-SOTC trial intervention pre-loss are compared to measures at 3, 5 and six months post-loss among bereaved family caregivers in a control group who received usual care pre- and post-loss from the palliative home-care unit. The FAM-SOTC intervention and the FAM-SOTC Post Loss intervention is delivered simultaneously in two separate clinical trials, where two sessions were delivered pre-loss (FAM-SOTC) and one session delivered post-loss (FAM-SOTC-PL).

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Jul 27, 2014
Actual Primary Completion Date :
Apr 20, 2017
Actual Study Completion Date :
Apr 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: FAM-SOTC-PL

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

Behavioral: FAM-SOTC-PL
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: Drawing forward narratives about the pre- and post-loss experience. Asking therapeutic/interventive questions, emphasising on the most pressing concerns also assessing health issues. Validating/acknowledging emotional responses. Assessing the need for specific information and recommendations regarding bereavement. The use of commendation/commending strengths, by focusing on and affirming the strengths of the family caregiver.

Outcome Measures

Primary Outcome Measures

  1. Change in Depression [3, 5, and 6 months]

    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.

  2. Change in Anxiety [3, 5, and 6 months]

    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. Change in Stress [3, 5, and 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • The eligibility criteria is that the primary family caregivers (who had been identified by the patient pre-death) are aged 18 years or older, bereaved due to cancer and that three months have passed since the deceased has died. Additional inclusion criteria is that the family caregivers have received care from a specialised palliative home-care unit at a university hospital in the advanced and final stage of their close relatives´ cancer trajectory.
Exclusion Criteria:
  • Non cancer and not being participating in another family level psycho-social intervention research.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Iceland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Iceland
ClinicalTrials.gov Identifier:
NCT03850132
Other Study ID Numbers:
  • UIceland-12018
First Posted:
Feb 21, 2019
Last Update Posted:
Feb 21, 2019
Last Verified:
Dec 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Iceland

Study Results

No Results Posted as of Feb 21, 2019