NCT02007564

Brief Summary

The research activities funded through PAR "Dissemination and Implementation Research in Health" in grant R21NR011112 "Legacy Intervention Family Enactment (LIFE)" have been varied and highly successful. The LIFE project was designed with three primary objectives. Aim 1 was to assess the efficacy of LIFE as delivered by Retired Senior Volunteers (RSVs) on palliative care patients': (a) mood and emotional experience; (b) physical symptom burden; and (c) experience of meaning. Aim 2 was to assess the efficacy of LIFE as delivered by RSVs on one primary family caregiver's: (a) caregiving stress; (b) mood and emotional experience; and (c) experience of positive aspects of caregiving. Aim 3 was to assess the ability of RSVs to deliver LIFE effectively. Although hospice and palliative care social workers frequently use reminiscence and creative activities with their patients 16, such interventions need to be more accessible to patients and families transitioning from community, hospital, and palliative care settings. If hospice or palliative care is not chosen as a treatment option, few means of delivering therapeutic reminiscence-based interventions exist. This represents a significant gap in practice and in the psychosocial palliative care intervention literature. Kazdin and Blase (2011) argue cogently that the community need for mental health services far outstrips the number of providers available to assist those in distress. They call strongly for new intervention delivery modes targeting prevention and treatment to alleviate suffering. Hence, the purpose of the present study was to evaluate the effectiveness of retired senior volunteers (RSVs), who are available nationally through the National Senior Corp Program, to deliver a three-session reminiscence and creative activity intervention previously found effective in improving palliative care patient and caregiver outcomes (Allen, 2009; Allen, Hilgeman, Ege, Shuster, \& Burgio, 2008). We hypothesized that palliative care patients and their caregivers in the RSV-delivered intervention group would demonstrate improved emotional and spiritual functioning relative to a supportive contact control group. If successful, this mode of treatment delivery (e.g., RSV intervention) would represent a significant step toward translation and greater access at earlier disease stages of therapeutic psychosocial interventions for individuals near the end of life and their family members.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2.5 years

First QC Date

November 17, 2013

Last Update Submit

July 13, 2014

Conditions

PainRetention Disorders, CognitiveOther Chronic IllnessPalliative Care

Keywords

Palliative care dyadsVolunteersCommunity-basedMixed methods

Outcome Measures

Primary Outcomes (1)

  • Change in Memorial Symptom Assessment Scale-Short Form

    Patients and caregivers independently rated the patient's physical and psychological symptoms and associated distress. Higher scores in the symptom category indicate the presence of more patient symptoms while higher bother scores indicate greater patient distress related to symptoms. Cronbach's alpha coefficients for the MSAS-SF subscales range from.76 to .87.

    Pre-Post Intervention (up to 20 weeks after baseline) and Follow-Up (up to 14 weeks later)

Secondary Outcomes (1)

  • Change in Meaning in Life

    Pre-Post Intervention (up to 20 weeks after baseline) and Follow-Up (up to 14 weeks later)

Other Outcomes (1)

  • Change in Brief Multidimensional Measure of Religiousness and Spirituality (BMMRS)

    Pre-Post Intervention (up to 20 weeks after baseline) and Follow-Up (up to 14 weeks later)

Study Arms (2)

LIFE Intervention

EXPERIMENTAL

RSVs received intensive training in the manualized intervention, including practice opportunities. The manual and accompanying workbook consist of instructions about using the steps of problem solving to decide on a period of life and creative activity project; constructing a project; evaluation of the activity; and additional questions. With the help of the RSV, dyads narrow the focus to one time period in the patients' life that could be adequately represented in one tangible project (scrapbook, audiotapes). The RSV and dyad brainstormed ways to portray the life story and then narrowed the focus to one meaningful project. The dyad gathered all necessary materials (such as pictures) and actively worked on completing a portion of the project between sessions.

Behavioral: LIFE Intervention

Supportive Telephone Contact Control

NO INTERVENTION

Patients and caregivers each received three separate, structured emotional support telephone calls with research staff (M duration = 13 minutes; SD = 6.5 minutes) to minimize differential drop-out with the RSV intervention group. Control callers asked questions of participants and then engaged in supportive conversations using empathic listening and reflection. Topics discussed included family, intergenerational ties, and important aspects of the patient's life, but structured reminiscence and the creative and therapeutic nature of legacy activities were not discussed.

Interventions

LIFE InterventionBEHAVIORAL

RSVs received intensive training in the manualized intervention, including practice opportunities. The manual and accompanying workbook consist of instructions about using the steps of problem solving to decide on a period of life and creative activity project; constructing a project; evaluation of the activity; and additional questions. With the help of the RSV, dyads narrow the focus to one time period in the patients' life that could be adequately represented in one tangible project (scrapbook, audiotapes). The RSV and dyad brainstormed ways to portray the life story and then narrowed the focus to one meaningful project. The dyad gathered all necessary materials (such as pictures) and actively worked on completing a portion of the project between sessions.

Also known as: Legacy Intervention Family Enactment (LIFE), Reminiscence and Creative Activity, Retired Senior Volunteer-Delivered Intervention
LIFE Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 or older
  • Living in the community or assisted living
  • Had an advanced illness or combination of chronic illnesses
  • Received a score of three or greater on the Vulnerable Elders Scale
  • Had no more than mild cognitive impairment
  • Received an average of four hours per week of care from a caregiver
  • Read and spoke English.
  • Identified by an eligible palliative care patient
  • Age 19 or older
  • Providing an average of four hours per week of care for the patient
  • Cognitively intact
  • Lived nearby
  • Read and spoke English.
  • Participants in the national Senior Corp program
  • Had a high school education
  • +2 more criteria

You may not qualify if:

  • If the patient was receiving hospice care
  • If either individual had schizophrenia or bipolar disorder
  • If the patient had a nursing home admission planned within three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama, Tuscaloosa

Tuscaloosa, Alabama, 35401, United States

Location

Related Publications (2)

  • Harris GM, Allen RS, Dunn L, Parmelee P. "Trouble won't last always": religious coping and meaning in the stress process. Qual Health Res. 2013 Jun;23(6):773-81. doi: 10.1177/1049732313482590. Epub 2013 Mar 28.

    PMID: 23539093BACKGROUND

  • Allen RS, Harris GM, Burgio LD, Azuero CB, Miller LA, Shin HJ, Eichorst MK, Csikai EL, DeCoster J, Dunn LL, Kvale E, Parmelee P. Can senior volunteers deliver reminiscence and creative activity interventions? Results of the legacy intervention family enactment randomized controlled trial. J Pain Symptom Manage. 2014 Oct;48(4):590-601. doi: 10.1016/j.jpainsymman.2013.11.012. Epub 2014 Mar 22.

    PMID: 24667180RESULT

MeSH Terms

Conditions

PainMemory Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

November 17, 2013

First Posted

December 11, 2013

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

US(1)