Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

Cancer Clinical Trial

Official title:

Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672294
• Other study ID #: IIR 11-347
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: July 8, 2016
• Start date: June 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Informal caregivers provide a majority of care for patients at the end of life. Lack of end of life preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care.

This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use

Description:

The investigators propose a randomized control trial to evaluate an intervention of end-of-life preparation and completion with Veterans and their caregivers at end-of-life. Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate the impact of the intervention session's qualitative content, examining variation associated with selected demographic variables, quality of family communication, and stage of illness on change.

Caregivers in the first group ("treatment") will meet with a facilitator three times for a period of forty-five minutes each. In the first session, subjects will be asked to discuss issues related to relationship life review.

In session two, participants will be asked to speak in more depth about issues such as regret and forgiveness. In the final session, subjects will focus on legacy and celebration. Caregivers in the second group ("attention control") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation CD or participate in a guided relaxation exercise.

Participants in both groups will receive pre and post-test measures administered by a blinded interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale, Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient days at home.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease.

Exclusion Criteria:

• No caregiver present.

• Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Heart Failure
• Lung Diseases
• Pulmonary Disease

Intervention

Other:
• Preparation and life completion
Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.
• Attention Control
Caregiver subjects will listen to a non-guided relaxation CD with facilitator.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Anxiety	Profile of Moods States (POMS) anxiety sub-scale	change in anxiety 5, 7, 15 weeks post-baseline	No
Secondary	Spirituality	Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale	5 and 7 weeks post-baseline	No
Secondary	Depression	Centers for Epidemiologic Study of Depression short form (CESD)	5 and 7 weeks post-baseline	No
Secondary	Anticipatory grief	Anticipatory Grief Scale	5 and 7 weeks post-baseline	No
Secondary	Patient days at home	number of patient days at home	5 and 7 weeks post-baseline	No
Secondary	Caregiver burden	Caregiver Reaction Assessment (CRA)	change in burden 5, 7 and 11 weeks post-baseline	No
Secondary	Caregiver completion and preparation	quality of family experience (QUAL-E fam)	change in preparation and completion 5, 7, 15 weeks post-baseline	No
Secondary	Prolonged Grief	Prolonged Grief 12 (PG-12) scale	5 and 7 weeks post-baseline	No