Clinical trial NCT03532061: Caregivers' Strengths-Skills: Managing Older Cancer Patients' Symptoms
Official title: Enhancing Family Caregivers' Strengths and Skills in Managing Older Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Familial Caregiver
Cancer
Symptom Management
COPE Principles
Problem-solving Skills Training Program
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Caregiver education and training programs that specifically target caregiver informational and training needs during the survivorship period have been limited. In recognition of families' direct involvement in health care decision-making, health advocacy and care provision, programs are needed that can maximize families' caregiving abilities and skills and provide them with the information and resources they may need to identify and address elderly cancer patients' post-treatment symptom management. The goal of this study was to implement and evaluate the efficacy of a short-term problem-solving skills training program (relative to participating in a caregiver support group) for familial caregivers to lower income older (55+) post-treatment cancer patients.

Detailed description: Cancer is one of the leading health disorders that can lead to impaired functioning and mortality in the elderly. With the aging of the population, more people will be living with a cancer diagnosis. The most dramatic increases will be among ethnic minorities. Advances in cancer detection and treatment are increasing cancer patients' survival and making it possible for many to be managed as outpatients and remain in the community. These advances have also contributed to an increased number of older adults living longer with/surviving for longer periods with having had cancer.

Recognition of the centrality of families' role in patients' treatment and recovery is widespread. Less attention, however, has been focused on developing programs and interventions that include or target the families' role during the cancer survivorship period, a period when patients are coping with the consequences of cancer and its treatment. During this period, when contact with the health care system is less intense, cancer patients' symptoms may go unrecognized or be poorly managed. Family members are directly involved in health care decision-making, functioning not only as a health care advocate for the elderly patient, but also ensuring that patients adhere to symptom management routines (e .g. encouraging them to take their pain medication, providing reassurance of the appropriateness of attending to certain symptoms). Family members' ongoing, frequent, contact with their elderly relative makes them ideally situated to monitor patients' functioning and detect subtle changes in their condition.

The goal of the proposed study was to implement and evaluate the utility of a brief training program to support and enhance the problem-solving caregiving skills of familial caregivers to facilitate optimum symptom control for older cancer patients during the post-treatment period. The rationale for this approach is based upon a diverse body of theoretical and empirical work. It represents a distillation and consolidation of research on cancer and the family, and draws from the broader bodies of work on disease management in the elderly, disparities in health care, cultural perspectives on illness, family caregiving in chronic disease, health behavior, health education and emerging approaches in palliative care.

Given the challenges patients and families may be experiencing during the post treatment period, ethical considerations mandated some type of service provision for the comparison condition. It was necessary to select an intervention that would be of potential benefit to the caregiver and/or the elderly patient, but would not necessarily be expected to directly impact the caregiver skills targeted in the Problem-solving condition. These considerations led to the selection of a caregiver support program as an acceptable comparison condition.

This investigation addresses a significant gap in the caregiver literature. While there is widespread recognition of the centrality of the family's role in long-term care situations, little attention has been focused on the post-treatment period. Programs that can empower familial caregivers and enhance their problem-solving strengths may enable them to be more effective in managing their relatives' care needs.

Eligibility criteria: Patient Inclusion Criteria:

1. Have a cancer diagnosis
2. Have completed active treatment
3. Be an older adult, aged 55 or older
4. Have a family member who is their caregiver
5. Understand English or Spanish
6. Not be severely cognitively impaired

Patient Exclusion Criteria:

* Patient must be in the post-treatment period

Familial Caregiver Inclusion Criteria:

1. Be 18 or older
2. Live with or have frequent (at least weekly face-to-face) contact with patient
3. Understand English or Spanish

Familial Caregiver Exclusion Criteria:

* Not be severely cognitively impaired

Primary outcomes:
measure: Change in Caregiver Social Problem-Solving Inventory Scale Score
timeFrame: Baseline, 1 & 7 months post-intervention delivery
Secondary outcomes:
measure: Caregiver's Satisfaction with Quality of Patient Care - FAMCARE Scale Score
timeFrame: Baseline, 1 & 7 months post-intervention delivery
Other outcomes:
Locations:
Study officials:
affiliation: New York University
name: Victoria H. Raveis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raveis VH, Tobin J, Karus D, Zhou R, Faber KE, Carrero M, Estrada I. Family caregiving to older, minority cancer survivors living in the community: Perspectives from a randomized control trial of caregiver problem-solving skills training. The Gerontologist 51(S2):496, 2011.
citation: Raveis VH, Tobin J, Karus D, Faber K, Zhou R, Carrero M, Estrada I. Family caregiving transitions: Addressing the care needs of older adults during the cancer survivorship period. The Gerontologist 50(S1): 475, 2010.
citation: Raveis VH, Karus D, Zhou R, Carrero-Tagle M, Faber K, Estrada I, Tobin JN. FamCare: Cognitive-behavioral problem solving training for family caregivers to cancer survivors. Gerontologist 56(Suppl_3): 684, 2016.