Abstract
Background:
We aimed to assess the feasibility, acceptability, and potential efficacy of ENABLE Cornerstone—a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer.
Methods:
Pilot randomized trial (November 2019-March 2021). Family caregivers of patients with newly-diagnosed Stage III/IV solid-tumor cancers were randomized to intervention or usual care. Intervention caregivers were paired with a specially-trained lay navigator who delivered 6 weekly, 20–60 minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed by completion of sessions and questionnaires (predefined as ≥80%). Acceptability was determined through intervention participants’ ratings of their likelihood to recommend. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks.
Results:
Sixty-three family caregivers were randomized (usual care=32; intervention=31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program was 9.4 from 1-Not at all likely to 10-Extremely likely. Over 24 weeks, the mean (SE) Hospital Anxiety and Depression score improved 0.30 (1.44) points in the intervention group and worsened 1.99 (1.39) in the usual care group (difference, −2.29, d=−0.32). The mean between-group difference scores in Caregiver-Quality of Life was −1.56 (usual care-minus-intervention, d=−0.07). Similar outcome results were observed for patient participants.
Conclusion:
We piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high and the preliminary efficacy for caregiver distress was promising.
ClinicalTrials.gov:
Keywords: family caregivers, cancer, palliative care, African American, telehealth
Precis:
We successfully piloted ENABLE Cornerstone, the first lay navigator-led, early palliative care, telehealth coaching intervention specifically tested for African American and rural-dwelling family caregivers of individuals with advanced cancer. Should this intervention demonstrate efficacy in our ongoing larger trial, it would yield a highly scalable and reproducible model of caregiver support primed for widescale implementation.
Lay summary:
To date, there have been very few programs developed to support under-resourced cancer family caregivers. To address this need, we successfully pilot tested an early palliative care program, called ENABLE Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. It is led by specially-trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. We are now testing Cornerstone in a larger trial. Should it demonstrate benefit, it would yield a model of caregiver support that could be widely implemented.
Introduction
Most patients who are newly-diagnosed with an advanced, metastatic cancer depend on receiving complex care and daily support from family and friend caregivers, a role that can be particularly burdensome for historically under-resourced groups, including African-American and rural-dwelling individuals.1 These under-resourced groups evidence similar disparities in serious illness and end-of-life outcomes, including poor access to healthcare and community-based palliative care services.2,3 Rural dwellers, regardless of race and particularly in the Southern U.S., have poor access to palliative care and hospice services.4 Poor healthcare access is also pernicious to the high proportion of African-American individuals living in the Southern U.S.5,6 The difficulties faced by these under-resourced patients extend to those family and friends that care for them.7,8 The caregivers often provide 8 hours of daily assistance to their care recipients,9 including managing and monitoring symptoms, providing transportation, coordinating care, communicating with healthcare providers and other clinicians, managing medications and breathing treatments, providing care, offering emotional, spiritual, and companionship support, and managing dietary needs.10,11 Recognizing these roles caregivers play in combination with issues of palliative care access, the need for targeted intervention testing for historically under-represented family caregiving populations has been spotlighted by the National Academy of Medicine,12,13 the National Cancer Institute,14 and others.15–17
Given this need, we conducted a formative evaluation to augment and adapt the content, format, and delivery of an early palliative care intervention that had demonstrated efficacy in a sample of nearly all White advanced cancer family caregivers in rural northern New England (ENABLE Caregiver)18,19 to a Southern U.S. population that included African American/Black and rural dwelling groups.20 This newly-adapted intervention, called ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, was revised and augmented with several features to enhance support for African American and rural-dwelling individuals including having mixed in-person and telephonic delivery, robust first-session rapport building, use of community-savvy lay navigators as coaches, long-term follow-up from diagnosis to bereavement, and additional topical content.21 For this study, we aimed to assess Cornerstone’s feasibility, acceptability, and potential efficacy in a small-scale randomized controlled trial. We expected the intervention to be feasible as demonstrated by adequate recruitment, retention, and intervention completion (predefined as ≥80% based on wanting to improve on our prior trial experiences18) and acceptable as assessed by acceptability scores. For preliminary efficacy, we hypothesized that intervention group caregivers and patients would have better distress and quality of life scores over 24 weeks compared to usual care.
Methods
Following the Consolidated Standards for Reporting Trials (CONSORT) guidelines,22 this was an intervention versus usual care, single-site, single-blind pilot randomized controlled trial.21 Patient participation was optional and included data collection only. The study protocol and data safety plan were approved by the University of Alabama at Birmingham (UAB) Institutional Review Board. The trial is registered in ClinicalTrials.gov (NCT03464188). Participants provided signed informed consent or gave verbal consent by telephone.
Participants
From November 2019 to March 2021, oncology outpatient clinics schedules of a large tertiary academic medical center in the Southeastern U.S. were screened by research coordinators. Potentially eligible patients were approached in person or by phone prior to their outpatient oncology visit to inquire if they had a family caregiver. If they did, caregivers were contacted to invite participation. Patients of agreeable caregivers were also invited but not required to participate (for data collection only as they did not receive any intervention). Patient participants were eligible if they were: 1) ≥18 years old; 2) diagnosed within the past 60 days of initial screening with an new advanced cancer, defined as metastatic solid-tumor cancers of the lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary, and melanoma; 3) either: a) resided in a rural zip code (as classified by the U.S. Census’ Rural-Urban Commuting Area system as small rural, large rural, and isolated or b) were African American/Black; 4) English-speaking; and 5) able to complete baseline measures. Patient exclusion criteria were: documented active severe mental illness (e.g., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse. Patients were required to have a willing family caregiver to participate in the study. Family caregivers were eligible if they were: 1) ≥18 years old; 2) identified by themselves or the patient as “a relative, friend, or partner that has a close relationship with you and who assists you with your medical care and who may or may not live in the same residence as you and who is not paid for their help”; 3) either caring for a patient: a) residing in a rural zip code or b) who is African American/Black); 4) caring for a patient with advanced-stage cancer; 5) English-speaking; and 6) able to complete baseline measures. Caregiver exclusion criteria included: self-reported active severe mental illness (e.g., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse. Caregiver and patient participants each received $20, $30, and $40 per completion of baseline, 8- and 24-week questionnaires, respectively (completed by either a blinded data collector, mailed paper-and-pencil survey, or online survey link). Caregivers received $30 for completing acceptability ratings. To adequately ascertain study feasibility and intervention components acceptability within the constraints of the study budget and timeline, a sample size of 60 dyads was prespecified.23
Randomization and Blinding
After consent and baseline measure completion, caregivers were randomized by the project manager (S.E.) to intervention or usual care with blocks lengths of 2, 4, and 6. Randomization was concealed and performed using computer-generated randomization scheme overseen by the study statistician (A.A.). Participants, clinicians, and interventionists were not blinded. The principal investigator (PI), co-investigators, and data collectors were blinded. Data were unblinded after analysis.
Intervention and Fidelity Monitoring
Details of the ENABLE Cornerstone intervention following the Template for Intervention Description and Replication (TIDieR) guidelines24 are described elsewhere,21 including extensive description of the intervention’s theoretical basis on the Pearlin Stress Process Model.25 In brief, specially-trained palliative care lay navigators hired locally facilitated a series of 6 weekly, one-on-one, 20- to 60-minute phone coaching sessions. Session 1 focused on rapport building and prompting caregivers to tell their story, including current and future concerns. Session 2 addressed coping and strategies to manage stress. Session 3 reviewed how caregivers can avail themselves of help for completing tasks, including addressing reasons why many caregivers do not ask for help. Session 4 covered approaches to organizing health information, managing medications and symptoms, and identifying local and national resources. Session 5 focused on reviewing and discussing dimensions of self-care. Session 6 reviewed decision making in serious illness and the role of families, including advance care planning, advance directives, and being a durable power of attorney for healthcare. Sessions lasted 32 minutes on average. These weekly sessions were followed by monthly check-in calls for 24 weeks to address any new or ongoing issues. All calls included caregiver distress screening, adapted in our prior work from NCCN patient distress screening.21,26 Coaches facilitated problem solving and goal setting support for caregivers who desired assistance with issues noted in distress screening.27 Participants endorsing distress screening Prior to starting weekly sessions, all intervention-group participants were mailed a Cornerstone Family Toolkit, a binder serving as a medical information organizer and containing information and resources pertaining to the 6 coaching sessions.
Validity and reliability of intervention delivery was maintained following guideline recommended fidelity strategies.28 The lay navigator coach underwent approximately 30 hours of training overseen by the PI and study staff that included independent readings, self-study, and role play and skills practice. The coach was guided by a script for each session and used a structured charting template to document key points of participant interactions to ensure all prescribed content was reviewed. All sessions were digitally-recorded and reviewed for fidelity using a checklist. There were no protocol deviations, defined as 3 consecutive ratings less than 80% over the course of the study. Each week, the lay navigator coach reviewed all sessions and calls over the prior week with the PI and a palliative care nurse practitioner (R.A.T.) to ensure adherence to the intervention protocol. Blinding was maintained during these supervisory meetings by excluding identifying information and referring to participants by their study ID numbers.
Measures
Feasibility and acceptability
Feasibility was measured by tracking completion rates of data collection and intervention session completion. An overall indicator of acceptability was ascertained after participants completed the 24-week study time frame by asking how likely they would be to recommend the program overall to someone else in a similar circumstance, from 1 (Not at all likely) to 10 (Extremely likely). For each of the six Cornerstone sessions, participants rated on scales of 1 to 10 how relevant (from 1 [Not at all relevant]) to 10 [Extremely relevant]), how helpful (from 1 [Not at all helpful] to 10 [Extremely helpful]), and how satisfied (from 1 [Not at all satisfied] to 10 [Extremely satisfied]) they were with the individual session.
Preliminary efficacy outcomes
Caregiver and patient distress:
The 14-item Hospital Anxiety and Depression Scale (HADS) was used to assess symptoms of anxiety and depression over the past 7 days (reported α=.82; score range: 0–42; higher scores=higher distress).29 The scale consists of two subscales, one for anxiety (e.g., feeling tense, restless, worried) and one for depression (e.g., cheerfulness, feeling slowed down). Subscale scores ≥8 indicate clinical high levels of anxiety or depression symptoms.
Caregiver quality of life:
The 35-item Caregiver Quality of Life-Cancer (CQOL-C) measured the caregiver’s overall quality of life, including physical, social, emotional, and financial aspects of wellbeing (reported α=.87; score range: 0–140; higher scores=worse quality of life).30
Patient quality of life:
The 14-item Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal-14) was used to assess patient quality of life (reported α=.76; score range: 0–56; higher scores=higher quality of life).31,32 Subscale domains measure physical, social/family, emotional and functional well-being and end of life concerns over the past 7 days.
Data Analysis
Descriptive statistics were used to tabulate sociodemographic characteristics, rates of intervention and questionnaire completion, and acceptability ratings. Baseline characteristics were compared between groups with measures of effect size. For examining preliminary efficacy, linear mixed-effect models with random effects for participant and week were fitted to the repeated measurements (baseline, 8-, and 24-weeks) for each caregiver or patient outcome variable. The models included fixed effects for timepoint, study group, and interactions between timepoint and group, which were to estimate the mean difference in change from baseline between groups at each post-intervention timepoint, i.e., the intervention effect at each follow-up timepoint. Next, the baseline standard deviation of each outcome was used to rescale the intervention effect and its 95% CI into a standardized measure of effect size, Cohen’s d (small~.2, medium~.5, large~.8).33
Results
Participant Characteristics
From November 2019 to March 2021, 183 caregivers were approached, 88 consented, and 63 were randomized: 32 to usual care and 31 to intervention (enrollment rate: 34.4%) (Figure 1). Caregivers had a mean age of 55.5 years and were mostly female (49 [77.8%]), married or living with a partner (39 [61.9%]), Protestant (55 [87.3%]), and spouse or partner of the patient (30 [47.6%]) (Table 1). Approximately half of the caregivers were African-American/Black (32 [50.8%]) and half rural-dwelling White (31, [49.2%]). Most caregivers were providing support every day (48 [76.2%]) to their care recipients for less than 1 year (42 [66.7%]), and over half provided this support for 5 or more hours a day (35 [55.6%]). Participating patients (N=40) had a mean age of 59.4 years, were over half female (25 [62.5%]) and had similar racial proportions as caregivers (Table 2). Patients had a wide variety of advanced cancer types, most had at least one or more co-morbidities (31 [77.5%]), and about half had a Karnofsky Performance Status score that was between 60 and 80 (21 [52.5%]).
Figure 1.
Participant screening, enrollment, allocation, and data collection
Table 1.
Demographic characteristics of family caregivers (N=63)
| Usual Care (n=32) | Intervention (n=31) | Effect size | |||
|---|---|---|---|---|---|
| n | (%) | n | (%) | V or d | |
| M=55.5 | SD=13.7 | M=55.5 | SD=14.2 | d=0 | |
| Gender | 0.01 | ||||
| Female | 25 | (78.1) | 24 | (77.4) | |
| Male | 7 | (21.9) | 7 | (22.6) | |
| Race | 0.02 | ||||
| White | 16 | (50.0) | 15 | (48.4) | |
| African-American/Black | 16 | (50.0) | 16 | (51.6) | |
| Hispanic | 0 | (0) | 0 | (0) | 0 |
| Marital status | 0.14 | ||||
| Married/Living with partner | 21 | (65.6) | 18 | (58.1) | |
| Never Married | 4 | (12.5) | 3 | (9.7) | |
| Separated/Divorced | 4 | (12.5) | 7 | (22.6) | |
| Widowed | 3 | (9.4) | 3 | (9.7) | |
| Education | 0.17 | ||||
| <High school | 3 | (9.4) | 1 | (3.2) | |
| High school or equivalent | 7 | (21.9) | 6 | (19.4) | |
| Some college or technical school | 12 | (37.5) | 15 | (48.4) | |
| College degree or higher | 10 | (31.3) | 9 | (29.0) | |
| Employment | 0.32 | ||||
| Full-time | 12 | (37.5) | 12 | (38.7) | |
| Part-time or student | 1 | (3.1) | 3 | (9.7) | |
| Retired or homemaker | 17 | (53.1) | 9 | (29.0) | |
| Unemployed | 0 | (0) | 1 | (3.2) | |
| Disability | 2 | (6.3) | 6 | (19.4) | |
| Religious affiliation | 0.20 | ||||
| Protestant | 29 | (90.6) | 26 | (83.9) | |
| Catholic | 1 | (3.1) | 3 | (9.7) | |
| None | 2 | (6.3) | 1 | (3.2) | |
| Other | 0 | (0) | 1 | (3.2) | |
| Patient relationship (The patient is my…) | 0.10 | ||||
| Spouse/partner | 14 | (43.8) | 16 | (51.6) | |
| Parent | 4 | (12.5) | 4 | (12.9) | |
| Other relative | 12 | (37.5) | 10 | (32.3) | |
| Friend/Other | 2 | (6.3) | 1 | (3.2) | |
| Number of years providing care | 0.30 | ||||
| <1 | 21 | (65.6) | 21 | (67.7) | |
| 1–2 | 2 | (6.3) | 6 | (19.4) | |
| 2–4 | 6 | (18.8) | 1 | (3.2) | |
| ≥5 | 3 | (9.4) | 3 | (9.7) | |
| Days/week providing care | 0.20 | ||||
| 2–4 | 4 | (12.5) | 3 | (9.7) | |
| 5–6 | 6 | (18.8) | 2 | (6.5) | |
| Every day | 22 | (68.8) | 26 | (83.9) | |
| Hours/day providing care | 0.22 | ||||
| 1–2 | 6 | (18.8) | 4 | (12.9) | |
| 3–4 | 8 | (25.0) | 9 | (29.0) | |
| 5–6 | 7 | (21.9) | 4 | (12.9) | |
| 7–8 | 2 | (6.3) | 3 | (9.7) | |
| >8 | 8 | (25.0) | 11 | (35.5) | |
| No response | 1 | (3.1) | 0 | (0) | |
Table 2.
Demographic characteristics of participating patients (N=40)
| Usual Care (n=22) | Intervention (n=18) | Effect size | ||||
|---|---|---|---|---|---|---|
| Characteristic | n | (%) | n | (%) | V or d | |
| Age in years [Mean, SD] | M=63.4 | SD=13.8 | M=54.4 | SD=13.5 | d=0.66 | |
| Gender | 0.23 | |||||
| Female | 16 | (72.7) | 9 | (50.0) | ||
| Male | 6 | (27.3) | 9 | (50.0) | ||
| Race | 0.16 | |||||
| White | 12 | (54.5) | 9 | (50.0) | ||
| African-American | 9 | (40.9) | 9 | (50.0) | ||
| Other | 1 | (4.5) | 0 | (0) | ||
| Hispanic | 1 | (4.5) | 0 | (0) | 0.14 | |
| Marital status | 0.25 | |||||
| Married | 13 | (59.1) | 11 | (61.1) | ||
| Never Married | 2 | (9.1) | 4 | (22.2) | ||
| Separated/Divorced | 6 | (27.3) | 2 | (11.1) | ||
| Widowed | 1 | (4.5) | 1 | (5.6) | ||
| Education | 0.40 | |||||
| < High school | 3 | (13.6) | 0 | (0) | ||
| High school or equivalent | 3 | (13.6) | 8 | (44.4) | ||
| Some college or technical school | 10 | (45.5) | 6 | (33.3) | ||
| College or above | 6 | (27.3) | 4 | (22.3) | ||
| Employment | ||||||
| Full-time | 1 | (4.5) | 8 | (44.4) | ||
| Part-time or student | 1 | (4.5) | 0 | (0) | ||
| Retired or homemaker | 13 | (59.1) | 4 | (22.2) | ||
| Unemployed | 1 | (4.5) | 2 | (11.1) | ||
| Disability | 6 | (27.3) | 4 | (22.2) | ||
| Charlson Comorbidity Index | 0.41 | |||||
| 0 | 8 | (36.4) | 1 | (5.6) | ||
| 1 | 9 | (40.9) | 13 | (72.2) | ||
| 2 | 3 | (13.6) | 3 | (16.7) | ||
| 3 | 1 | (4.5) | 1 | (5.6) | ||
| 5 | 1 | (4.5) | 0 | (0) | ||
| Karnofsky Performance Status* | 0.34 | |||||
| 60 | 2 | (11.8) | 0 | (0) | ||
| 70 | 3 | (17.6) | 4 | (23.5) | ||
| 80 | 6 | (35.3) | 6 | (35.3) | ||
| 90 | 4 | (23.5) | 4 | (23.5) | ||
| 100 | 2 | (11.8) | 3 | (17.6) | ||
| Not recorded | 5 | (22.7) | 1 | (5.6) | ||
| Cancer Types | .41 | |||||
| Breast | 6 | (27.3) | 3 | (16.7) | ||
| Colon/Rectal | 5 | (22.7) | 3 | (16.7) | ||
| Lung | 4 | (18.2) | 2 | (11.1) | ||
| Prostate | 3 | (13.6) | 2 | (11.1) | ||
| Pancreatic | 1 | (4.5) | 1 | (5.6) | ||
| Head and Neck | 1 | (4.5) | 2 | (11.1) | ||
| Bladder/Kidney | 0 | (0.0) | 2 | (11.1) | ||
| Other | 2 | (9.1) | 3 | (16.7) | ||
| Anticancer treatments: | ||||||
| Surgery | 1 | (4.5) | 2 | (11.1) | 0.12 | |
| Chemotherapy | 11 | (50.0) | 8 | (44.4) | 0.06 | |
| Radiotherapy | 3 | (13.6) | 1 | (5.6) | 0.13 | |
| Immunotherapy | 0 | (0) | 2 | (11.1) | 0.25 | |
| Participating in other clinical trials | 1 | (4.5) | 0 | (0) | 0.14 | |
| Advanced Directive at baseline | 6 | (27.3) | 4 | (22.2) | 0.06 | |
Notes:
Karnofsky performance status: Degree of functional impairment from 0 (dead) to 100 (no evidence of disease).
Cramer’s V: small~0.1, medium~0.3, large~0.5; Cohen’s d: small~0.2, medium~0.5, large~0.8.
Feasibility and Acceptability
Out of 170 possible data collection time points for caregivers, 147 were completed (86.5%). Patients completed 95 out of a possible 104 data collection time points (91.3%). Over 24 weeks, there were 5 caregiver and 1 patient withdrawals and 13 patient deaths (11 of whom were participating in the study). Out of 155 possible intervention sessions (excluding sessions for caregivers whose patients died or who withdrew before completion), caregivers completed 101 sessions (65.2%). Thirteen of the 31 intervention caregivers completed all 6 sessions (42%), 5 did not complete any sessions (despite not withdrawing), and 5 were still receiving weekly sessions when their care recipient died.
Regarding intervention acceptability, average caregiver ratings for recommending the program to other caregivers in a similar circumstance was 9.4 on a scale from 1-Not at all likely to 10-Extremely likely. Ratings of individual session relevance, helpfulness, and satisfaction ranged from 8.2 to 9.3, with the highest scores reported for Session 5 (“Taking care of yourself”) (Table 3). Overall scores for relevance, helpfulness, and satisfaction were 8.9, 9.2, and 9.2, respectively.
Table 3.
Relevance, helpfulness, and satisfaction of Cornerstone Sessions
| Weekly Session | How relevant? | How helpful? | How satisfied? |
|---|---|---|---|
| Session 1: Sharing your caregiving story | 8.9 | 8.8 | 9.2 |
| Session 2: Coping with stress | 8.9 | 8.5 | 8.8 |
| Session 3: Getting help | 8.2 | 8.3 | 8.7 |
| Session 4: Improving your support skills | 8.2 | 8.3 | 8.8 |
| Session 5: Taking care of yourself | 9.2 | 8.9 | 9.3 |
| Session 6: Decision making and planning for the future | 8.4 | 8.6 | 8.8 |
| Overall | 8.9 | 9.2 | 9.2 |
Preliminary Efficacy
Table 4 shows model-predicted means for caregiver outcomes by timepoint and group, estimated change from baseline by group, and between-group comparisons of change from baseline at 8 and 24 weeks. At 24 weeks, the mean (SE) HADS distress score improved 0.3 (1.44) points in the intervention group and worsened 1.99 (1.39) in the usual care group (difference, −2.29, d=−0.32). The mean (SE) HADS anxiety subscale score improved 1.1 (0.9) points in the intervention group and worsened 0.8 (0.84) points in the usual care group (difference, −1.94, d=−0.44). The mean (SE) CQOL-C score improved 0.4 (4.5) points in the intervention group and worsened 1.1 (4.3) points in the usual care group (difference, −1.56, d=−0.07).
Table 4.
Caregiving preliminary efficacy outcomes*
| Usual Care | Intervention | Difference in Change | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from W 0 | Change from W0 | Standardized* | ||||||||||||||
| Outcome | Week | n | Mean | SE | Mean | SE | n | Mean | SE | Mean | SE | Mean | SE | Cohen’s d | 95% CI | 95% CI |
| Total distress (HADS Total Score) | 0 | 32 | 13.69 | 1.41 | - | - | 31 | 13.25 | 1.43 | - | - | - | - | - | - | - |
| 8 | 26 | 14.13 | 1.49 | 0.44 | 1.21 | 23 | 13.13 | 1.55 | −0.12 | 1.28 | −0.56 | 1.76 | −0.08 | −0.57 | 0.41 | |
| 24 | 18 | 15.68 | 1.64 | 1.99 | 1.39 | 17 | 12.95 | 1.69 | −0.3 | 1.44 | −2.29 | 2 | −0.32 | −0.88 | 0.24 | |
| Anxiety (HADS Anxiety Subscale Score) | 0 | 32 | 7.53 | 0.84 | - | - | 31 | 8.32 | 0.85 | - | - | - | - | - | - | - |
| 8 | 26 | 7.65 | 0.89 | 0.12 | 0.73 | 23 | 7.5 | 0.93 | −0.82 | 0.77 | −0.94 | 1.07 | −0.21 | −0.69 | 0.27 | |
| 24 | 18 | 8.36 | 0.98 | 0.83 | 0.84 | 17 | 7.21 | 1.01 | −1.12 | 0.87 | −1.94 | 1.21 | −0.44 | −0.98 | 0.11 | |
| Depression (HADS Depression Subscale Score) | 0 | 32 | 6.15 | 0.72 | - | - | 31 | 4.91 | 0.74 | - | - | - | - | - | - | - |
| 8 | 26 | 6.48 | 0.77 | 0.34 | 0.65 | 23 | 5.61 | 0.8 | 0.7 | 0.68 | 0.37 | 0.94 | 0.09 | −0.39 | 0.58 | |
| 24 | 18 | 7.32 | 0.85 | 1.17 | 0.75 | 17 | 5.71 | 0.88 | 0.8 | 0.77 | −0.37 | 1.07 | −0.1 | −0.65 | 0.46 | |
| Quality of Life (CQOL-C) | 0 | 32 | 85.7 | 3.94 | - | - | 31 | 87.24 | 4 | - | - | - | - | - | - | - |
| 8 | 26 | 89.03 | 4.21 | 3.33 | 3.77 | 23 | 85.17 | 4.41 | −2.07 | 3.98 | −5.4 | 5.48 | −0.24 | −0.73 | 0.25 | |
| 24 | 18 | 86.83 | 4.72 | 1.13 | 4.34 | 17 | 86.81 | 4.86 | −0.42 | 4.47 | −1.56 | 6.23 | −0.07 | −0.62 | 0.49 | |
Estimates from linear mixed-effects models
For patients at 24 weeks (Table 5), the mean (SE) HADS score improved .7 (1.7) points in the intervention group and 0 (1.6) points in the usual care group (difference, −0.73, d=−0.11). HADS depressive symptom subscale scores improved 0.2 (1.1) points in the intervention group and worsened 1.2 (1.2) points in the usual care group (difference, −1.38, d=−.39). Mean (SE) FACIT-Pal-14 scores improved .03 (2.1) points in the intervention group and 2.24 (2.0) points in the usual care group (difference, −2.21, d=−0.27).
Table 5.
Patient preliminary efficacy outcomes*
| Usual Care | Intervention | Difference in Change | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from W0 | Change from W0 | Standardized* | ||||||||||||||
| Outcome | Week | n | Mean | SE | Mean | SE | n | Mean | SE | Mean | SE | Mean | SE | Cohen’s d | 95% CI | 95% CI |
| Total distress (HADS Total Score) | 0 | 22 | 11.75 | 1.58 | - | - | 18 | 9.69 | 1.7 | - | - | - | - | - | - | - |
| 8 | 17 | 10.59 | 1.67 | −1.15 | 1.41 | 14 | 10.24 | 1.85 | 0.55 | 1.57 | 1.7 | 2.15 | 0.26 | −0.4 | 0.93 | |
| 24 | 12 | 11.75 | 1.84 | 0 | 1.6 | 12 | 8.96 | 1.91 | −0.73 | 1.65 | −0.73 | 2.32 | −0.11 | −0.84 | 0.61 | |
| Anxiety (HADS Anxiety Subscale Score) | 0 | 22 | 5.66 | 0.84 | - | - | 18 | 4.96 | 0.9 | - | - | - | - | - | - | - |
| 8 | 17 | 4.29 | 0.89 | −1.37 | 0.76 | 14 | 4.31 | 0.98 | −0.65 | 0.85 | 0.72 | 1.16 | 0.19 | −0.42 | 0.8 | |
| 24 | 12 | 4.57 | 0.98 | −1.1 | 0.87 | 12 | 4.51 | 1.02 | −0.45 | 0.89 | 0.65 | 1.25 | 0.17 | −0.49 | 0.83 | |
| Depression (HADS Depression Subscale Score) | 0 | 22 | 6.12 | 0.94 | - | - | 18 | 4.72 | 1.01 | - | - | - | - | - | - | - |
| 8 | 17 | 6.41 | 1 | 0.29 | 0.92 | 14 | 6.11 | 1.11 | 1.39 | 1.02 | 1.1 | 1.4 | 0.31 | −0.49 | 1.11 | |
| 24 | 12 | 7.28 | 1.12 | 1.16 | 1.04 | 12 | 4.5 | 1.16 | −0.21 | 1.07 | −1.38 | 1.51 | −0.39 | −1.26 | 0.47 | |
| Quality of life (FACIT-Pal-14) |
0 | 22 | 37.43 | 1.99 | - | - | 18 | 41.61 | 2.15 | - | - | - | - | - | - | - |
| 8 | 17 | 37.88 | 2.11 | 0.45 | 1.8 | 14 | 39.33 | 2.33 | −2.27 | 2 | −2.72 | 2.74 | −0.33 | −1.01 | 0.34 | |
| 24 | 12 | 39.67 | 2.32 | 2.24 | 2.04 | 12 | 41.64 | 2.42 | 0.03 | 2.1 | −2.21 | 2.96 | −0.27 | −1 | 0.46 | |
Estimates from linear mixed-effects models; using baseline SD; all models adjusted for patient age
Discussion
To address the need for interventions testing with historically under-resourced African-American/Black and rural-dwelling family caregivers of individuals with advanced cancer, we conducted a small-scale, pilot randomized controlled trial of Project ENABLE Cornerstone. While intervention session completion rates were below our a priori target of 80% and the enrollment rate was modest, our results also demonstrated high intervention acceptability, high data collection completion rates, and promising indicators of preliminary efficacy. Our results and experiences, most of which were gained during the COVID-19 pandemic, have led to substantial adaptations of our protocol procedures and strategies to overcome obstacles to recruitment and intervention adherence.
While our data collection rates were excellent, our enrollment rate was modest at 34%. While this rate is consistent with other cancer caregiver interventions as reported in a recent systematic review,34 we believe the lower than anticipated rate can be largely explained by the considerable impact that COVID-19 had on research operations at our clinical site beginning in March 2020. All in-person recruitment was suspended by our medical center, many patients began to transition their oncology treatment care to their local hospitals, and many caregivers were feeling too overwhelmed with navigating both COVID-19 precautions and their relative’s cancer to participate in a research study.35 To address these challenges, we employed several strategies. First, we adapted our in-person recruitment approach during a patient’s outpatient clinic visit to a multimodal mail-and-phone approach. This allowed us to contact and correspond with potential participants outside of the oftentimes stressful and hectic clinical setting and in the safety and comfort of their own homes and at convenient times. Second, we gained permissions to waive signed informed consent and acquire verbal consent by phone after which participants were mailed a copy of the consent. We also obtained a waiver of the requirement that individuals complete a W-9 form (which requires a social security number) when enrolling to be provided an incentive for data collection completion. Third, we partnered with a recruitment and retention core that specializes in enrollment of under-resourced groups and racial minorities, populations who have traditionally been inadequately offered clinical trial participation and disproportionately impacted perniciously by COVID-19. We have found these strategies to be effective and implemented them in our current efficacy trial of Cornerstone (NCT04318886).
The intervention’s acceptability was rated highly by participants and had promising indicators of potential efficacy for both caregivers and patients. This is significant because, first, very few interventions for cancer family caregivers have been specifically test with African American/Black and rural-dwelling caregivers17 and have demonstrated only marginal efficacy for both caregiver and patient outcomes.36,37 Second, while this pilot was underpowered to definitively test efficacy, the effect sizes for caregiver anxiety (d=−0.44) and patient depression (d=−0.39) were clinically relevant, despite lower than intended intervention session completion rates (65%). These observed effects were also noted over a longer intervention duration than most cancer caregiver intervention trials to date, indicating another strength of the study.17 Third, the intervention suggested potential efficacy for patients even though the intervention was delivered to caregivers. This suggests caregivers were able to care for patients more effectively with the support and skills training of the intervention. Moreover, should these same results bear out in a larger trial, it could help persuade health systems and payers to support this type of intervention for caregivers given its benefit on patient outcomes. Finally, this intervention was designed to be highly scalable through its telehealth approach, use of a largely untapped workforce of lay navigators, relatively brief session length (average 32 minutes), and testing with a heterogenous range of cancer types.
This pilot trial had several limitations. First, we are unable to generalize our findings given our small sample size. However, a larger trial is now active and enrolling (NCT04318886). Second, given our small sample size, we are unable to determine if specific subgroups were more likely to benefit from the intervention. Third, we are unable to speculate on the mechanisms and “active ingredients” of the intervention’s potential effectiveness, which is planned for our future work. In particular, we plan to measure resilience, social support effectiveness, and goal setting. Finally, our 24 week-timeframe for this study does not allow us to ascertain possible longer-term benefits of the intervention, particularly at the patient’s end-of-life and during the caregiver’s bereavement, which have been reported to be highly interrelated.38 Given the number of observed deaths in this pilot (n=13) and the overall shorter survival time of patients with advanced cancer, measuring these distal outcomes will be imperative to demonstrating the intervention’s potential downstream benefits.
To date, there has been very little intervention development and testing with historically under-resourced cancer family caregiving populations.17 We successfully pilot tested ENABLE Cornerstone, the first lay navigator-led, early palliative care, telehealth coaching intervention specifically tailored for African American/Black and rural-dwelling family caregivers of individuals with advanced cancer. Should this intervention demonstrate efficacy in our ongoing larger trial, it would yield a highly scalable and reproducible model of caregiver support primed for widescale implementation.
Acknowledgments:
We thank all partnering oncologists, clinicians, and staff at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham for supporting this study. We thank Dr. Chao-Hui Sylvia Huang for providing as needed clinical psychosocial support. We also thank Julie Schach, James Mapson, Gjuana Cleveland, Tawny S. Martin, Diane Williams, Gail Averett, and Beth Ruf for assisting with recruitment and data collection and Charis Smith, Kathryn Louis, Peggy McKie, Kayleigh Curry, and Dr. Bailey Hendricks for study coordination. Most of all, we thank all family caregivers and patients for contributing their time to this study.
Funding statement:
This study was funded by the National Institute of Nursing Research (R00NR015903).
Footnotes
Conflict of interest:
All authors declare no conflict of interest.
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