Cancer Clinical Trial
Official title:
Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Individualized Dual Process Intervention for Bereaved Partners After Cancer Death
Individuals providing end-of-life caregiving to partners with terminal cancer often begin the bereavement process before the patient dies and with additional sources of stress. We know that grief for these partners can be long-term and impact virtually every aspect of their lives. This project will test the effectiveness of a new promising intervention that uses a dual process model (DPM) which focuses both on loss orientation (emotional loss and grief (referred to as LO)) and restoration orientation (learning new tasks of living that may have been the primary responsibility of the spouse who has died (referred to as RO tasks)).
The past emphasis on only the psycho-emotional features of loss has resulted in a lack of
attention to the restoration-focused adaptation. Middle-aged and older bereaved persons,
including those who previously provided care for a terminally ill spouse or partner, are
confronted with unfamiliar daily demands. Even though death due to a terminal illness like
cancer may be anticipated, the surviving spouse/partner may be so involved in caring for the
dying person and consumed by the emotional distress that accompanies it, there is little
time or energy to plan for the changes, some of which are unforeseen prior to the loss. This
gap in abilities suggests a need for intervention strategies that improve skills such as
mastering tasks of daily living, engaging in self-care behaviors, and functioning socially
as a single or uncoupled person in society. One of the major findings in our previous
research was the strong association between competencies in tasks of daily living and more
favorable adjustments to psycho-emotional aspects of grief.
Some tasks of daily living may have been the primary responsibility of the deceased person.
If these skills are not acquired during bereavement, the health, functioning, autonomy and
overall quality of life of the bereaved could be adversely affected. Furthermore, the
inability to accomplish these tasks interferes with the emotion-focused energy the bereaved
need to direct toward the loss itself. Effectively coping with the secondary stress
associated with these new challenges reduces the emotional disruption of bereavement. As new
skills are gained, the bereaved feel more confident to meet future challenges in their daily
lives and some may experience personal growth as they venture into "previously uncharted
territory" during a time of transformation independent of their deceased spouses/partners.
While some of the RO challenges are practical, others have health implications (some have
both). Self-care behaviors are often partnered activities among couples and the partner's
death frequently disrupts these behavioral patterns or interferes with the ability to engage
in new ones. The importance for bereaved persons to care for themselves while still
addressing the need to grieve represents another set of secondary stressors requiring RO
coping strategies. Also, those who more effectively engage in self-care could conceivably be
in a better position to address the negative emotional effects of the loss. An important
feature of RO is the adaptation to new roles and identities and establishing new
relationships and maintaining social connectedness. Older and middle aged bereaved
spouses/partners prefer to maintain the meaningful relationships and activities they have
had throughout their lives but they also want to learn ways to access services and programs
more effectively and how to maximize opportunities to meet and socialize with others.
Activities can include inexpensive entertainment and leisure options, safe places to go to
socialize with others, and volunteering opportunities to help others so they can remain
socially connected and function more effectively and comfortably as a single person. These
activities provide potential linkages to the service network and opportunities for time away
from grief itself.
The overall intent of the I-DPM intervention is to more effectively stimulate both LO and RO
coping processes as well as the oscillation between them than what would otherwise occur
without an exposure to such a treatment. At best the usual care hospice caregivers receive
after the death of the patient is primarily LO focused as well as infrequent. We hypothesize
that those who receive the I-DPM intervention will show greater improvements over time in
bereavement outcomes largely because the intervention content will stimulate both LO and RO
processes - the telephone support will focus primarily on LO coping while the home visits
are intended to address RO issues causing the most concern for the bereaved. In our earlier
work we documented that LO coping was directly related to grief, depression, bereavement
coping self-efficacy, and loneliness, while RO coping was strongly associated with
competencies and personal growth. RO coping, however, also was related to the aforementioned
loss-oriented outcomes most likely because of the positive relationship between competencies
and the psycho-emotional aspects of bereavement mentioned above and the confidence one can
master new challenges along with the perception of growth that accompanies it.
To summarize, bereavement interventions that have traditionally focused on grief work and
psycho-emotional outcomes have only been moderately effective, largely due to having a
limited focus on emotional coping. Alternatively, an intervention that addresses RO in
addition to LO as we are testing in the DPM intervention could provide a more promising
solution by helping the bereaved develop skills specific to practical daily challenges as
well as the emotional disruption and upset that permeate bereavement.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|