Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss

NCT ID: NCT03850132

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-27
• Study Completion Date: 2017-04-20

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.

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).

Conditions

Bereavement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FAM-SOTC-PL

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

Group Type: EXPERIMENTAL

FAM-SOTC-PL

Intervention Type: BEHAVIORAL

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.

Interventions

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:

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iceland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

UIceland-12018

Identifier Type: -

Identifier Source: org_study_id