Cancer and Aging: Reflections for Elders-Expressive Writing Intervention: A Pilot Study

Abstract

Objectives

The Cancer and Aging: Reflections for Elders Expressive Writing Intervention (CARE-Express) was developed to enhance coping and minimize psychological distress in older adults with cancer. The aim of the current study is to evaluate the feasibility and initial efficacy of CARE-Express.

Materials and Methods:

Seventy-one distressed older adults (≥70) with cancer were assigned to CARE-Express (n=41) or the Enhanced Social Work Control (ESWC) arm (n=30). Participants completed five telephone sessions over seven weeks and were assessed on psychosocial variables at baseline, post-intervention, and four months post study enrollment. Feasibility was assessed by examining rates of eligibility, acceptance, retention, assessment, and fidelity. Initial efficacy was evaluated using standardized effect sizes.

Results:

Adequate rates of acceptance (29%), eligibility (66%), retention (90%), assessment (70% at post-intervention, 63% at four month follow-up), and fidelity (97%) were observed. At post-intervention, participants receiving CARE-Express reported less depression compared to ESWC (d=0.69, p=0.01) and lower demoralization (d=0.50, p=0.06). A small/moderate effect was demonstrated for increased total spirituality scores (d=0.41, p=0.07), meaning/peace (d=0.32, p=0.20) and faith (d=0.35, p=0.07). The CARE-Express group reported greater reductions in behavioral disengagement (d = 0.44, p = 0.06), while ESWC demonstrated a small effect for active coping (d=0.21, p=0.31). At four months, differential effects of CARE-Express had attenuated, though small/moderate, effects in favor of CARE-Express remained.

Conclusion:

Results support the feasibility of CARE-Express and its potential positive impact on psychological well-being.

Background

It is projected that there will be 24 million new cancer cases worldwide in 2035, a two-fold increase from the incidence in 2012¹. This increase is largely driven by the increase in the number of older adults worldwide. Of the new cancer diagnoses, 54% occur in individuals 65 years or older ², and by 2030, that number is expected to surge to seventy percent³. Therefore, the importance of understanding the unique needs of older patients with cancer and how to best care for them is a major public health concern.

An estimated 41% of older adults with cancer report significant distress, and approximately one-third of older survivors report cancer-related health worries, which is a predictor of both depression and anxiety^4,5. Despite the success of mental health interventions for older patients with other chronic illnesses and patient preferences for a non-pharmacological treatment, few psychotherapy approaches have been specifically developed for or evaluated in older patients with cancer^6,7. Thus, the current pilot study sought to evaluate a writing intervention to address the unique needs of older patients coping with aging and cancer.

A growing number of randomized control trials (RCTs) have evaluated Expressive Writing Interventions (EWI) in both healthy and clinical populations^8–13. In these trials, writing is conceptualized as a mechanism to facilitate expressive self-disclosure and self-affirmation, which are thought to improve physical and mental health^14,15. While the underlying mechanisms of written disclosure paradigms are not well understood, several theories have been proposed to explain the beneficial effects, including emotional disinhibition, cognitive adaptation, and emotional processing/exposure¹⁶. For example, it is hypothesized that labelling an event and its surrounding emotions linguistically leads individuals to re-structure and make sense of an emotional experience, facilitating exposure to and an understanding of the event(s) itself^13,16–18. Experts suggest that these changes in basic cognitive and linguistic processes are responsible for the positive benefits seen on physical and psychological health in EWI studies^10,14. Despite the growing number of EWI trials showing a wide range of benefits in cancer populations^8,12,19–23, the efficacy of EWIs in patients with cancer and survivors has not been consistently supported⁸. There is reason to believe that an EWI may be of specific benefit to older patients with cancer as declines in physical functioning limit engagement in certain adaptive coping strategies such as exercise and social engagements outside the home. The COVID-19 pandemic has also highlighted the necessity of telehealth interventions, particularly those for populations that are immunocompromised and/or older.

The Cancer and Aging Reflections for Elders: Expressive Writing Intervention (CARE-Express) was developed based on the Cancer and Aging: Reflections for Elders (CARE) psychotherapy intervention⁷. CARE was developed to focus on themes, coping, and developmental processes specifically related to aging adults and their cancer experience. CARE has been shown to be a feasible intervention with participants reporting reduced depression, anxiety, and demoralization⁷. The intervention is based on the integration of two well established models in the psychosocial literature: the coping paradigm of Folkman^24–26 and the developmental stages of life as outlined by Erikson^27–29 and expanded on by Vaillant³⁰. For CARE-Express, the original CARE manual was adapted into reflective writing exercises designed to promote reappraisal through reflective writing^14,17,18. CARE-Express was designed to be administered via telephone in order to circumvent barriers to participation (i.e., physical limitations, limited access to transportation, geographical isolation) that older adults may face. The integration of CARE content with an EWI was hypothesized to bolster the impact of EWI in older adults with cancer and address the inconsistent results shown in the EWI literature.

The primary aim of this pilot study was to test the feasibility, tolerability, and acceptability of CARE-Express by examining rates of eligibility, acceptance, and adherence. It was hypothesized that CARE-Express would be feasible, tolerable, and acceptable. The secondary aim was to examine the preliminary effects (i.e., effect sizes) of CARE-Express on psychological wellbeing compared to a historical group that received an Enhanced Social Work (ESWC) intervention. It was hypothesized that CARE-Express would improve psychological well-being compared to ESWC.

Methods

Study Design

Participants were recruited from outpatient clinics at Memorial Sloan Kettering Cancer Center (MSK). This study was approved by the MSK (Protocol # 09–116) Institutional Review Board and registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT00984321. Participants were recruited for the CARE-Express as a single-arm study and were compared to a historical ESWC group. All study contact including recruitment, delivery of interventions, and data collection was completed via telephone.

Participants

Inclusion criteria for both intervention arms were: 1) ≥70 years old 2) ≥6 months post-diagnosis for breast, prostate, lung, lymphoma, or gynecological cancer and on active cancer treatment (or within 6 months of active treatment); 3) English-speaking; 4) ≥ 4 on the Distress Thermometer (DT)³¹, or ≥ 6 on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale^32–34, or ≥ 6 on Hospital Anxiety and Depression Scale (HADS) Depression Subscale^32–34; 5) ≥60 on Karnofsky Performance Rating (KPR)³⁵; and 6) ≤ 11 on the Blessed Orientation Memory Concentration (BOMC)³⁶ test.

Procedure

Medical records of prospective patients were screened for initial inclusion criteria (i.e., age, cancer diagnosis, and treatment). If initial criteria were met, patients were sent a letter and research staff followed-up via telephone. If interested in participation, patients were screened over the telephone for secondary inclusion criteria, which included the HADS, DT, KPR, and BOMC. If inclusion criteria were met, participants were verbally consented over the telephone and enrolled to the study. This study was considered minimal risk and written consent was not required. The study utilized historical data for comparisons (described below), and participants were therefore not randomized.

Participants were administered a battery of questionnaires (see Outcomes): baseline (within two weeks prior to starting the intervention), post-intervention (within four weeks of completing the last intervention session), and at four months post-study enrollment. All questionnaires were completed via telephone with a trained research assistant (RA).

CARE-Express.

CARE-Express was designed by tailoring the themes from the pre-existing CARE intervention into an expressive writing format⁷. Content from CARE included Folkman’s cognitive model of coping ^24–26 and Erikson’s developmental model of psychosocial tasks associated with the later stages of life^7,27–30. Writing exercises were designed to: 1) Provide a supportive emotional environment for older cancer patients in which they can explore personal issues and feelings about their experiences of cancer and aging to make confronting difficult emotion(s) more tolerable, 2) Identify the challenges associated with cancer and aging and to explore strategies to cope with them, 3) Address the social issues of isolation and societal stigma relating to cancer and aging to promote better self-image and coping.

CARE-Express consisted of five sessions (45 minutes; Table 1) which took place over approximately seven weeks. Sessions were facilitated by a writing mentor (three interventionists total) from Memorial Sloan Kettering’s Visible Ink Program, a program that offers patients the opportunity to write with the one-on-one support of an experienced writing mentor³⁷. Each session was outlined as follows: 1) discussion of the selected reading and topic, 2) administration of the corresponding writing prompt, 3) time for the participant to write freely, and 4) discussion of the participants’ writing and its relation to the corresponding topic (Table 1).

Table 1.

CARE-Express Session Topics, Themes, & Outline

Session	Topic7	Theme(s)	Outline
1	Cancer Story & Overview	Explore Patients Life Story and History of Cancer & Aging	1. Introductions: Therapist & patient 2. Overview of intervention (treatment goals, logistics, theoretical framework) 3. Introduce session 1 theme  a. Read and discuss excerpt from “Metamophosis “ by Franz Kafka  b. Patient writes in response to the prompt, “How have cancer and aging affected the story of yourlife?” 4. Review writing 5. Wrap-Up (review session 1, introduce session 2)
2	Coping with Cancer & Aging	Coping with Losses and Facing the Unknowns of Cancer & Aging	1. Check in & brief review of session 1 2. Introduce session 2 theme  a. Read and discuss excerpt from “Head, Heart” by Lydia Davis  b. Patient writes in response to the prompt, “Write about the losses you have experienced, or expect to experience, and how you continue to go forward despite them ” 3. Wrap-Up (review session 2, introduce session 3)
3	Loneliness & The Stigma of Cancer & Aging	Loneliness and the Experience of Cancer & Aging; Loneliness and reduced social circles in later years	1. Check in & brief review of session 2 2. Introduce session 3 theme  a. Read and discuss excerpt from“The End of Your Life Book Club ” by Will Schwalbe  b. Patient writes in response to the prompt, “ Write about the difference between being alone and being lonely” 3. Wrap-Up (review session 3, introduce session 4)
4	Making Peace with One’s Life	Making Peace with One’s Life and Acquiring Wisdom	1. Check in & brief review of session 3 2. Introduce session 4 theme  a. Read and discuss excerpt from“The Cathedral” by Raymond Carver  b. Patient writes in response to the prompt, “ With the wisdom you’ve gained through the years, what advice would you offer others?” 3. Wrap-Up (review session 4, introduce session 5)
5	Reflection & Review	Summarize & review: the goals of this final session are for the facilitator and patient to reflect together about the last 4 sessions, obtaining thoughts and feelings surrounding the last session	1. Check in: personally and medically 2. Termination: draw attention to the progression of session topics through to today’s 5th and final session, identify and emphasize weekly themes in the process. 3. Introduce session 5 theme  a. Read and discuss excerpt from “A Spiritual Journey” by Wendell Berry  b. Patient writes in response to the prompt, “Looking back from this last session, what have you learned from the previous sessions that you might take forward?” 4. Reflection on overall experience. Express appreciation for participation and say goodbyes.

ESWC.

This study utilized a historical control condition, ESWC, adopted from the original CARE pilot RCT⁷. Participants in the control group also completed five phone calls over approximately seven weeks, matching the number of sessions and time interval of the CARE-Express arm. Participants in this group received a referral to the MSK 65+ social work program and had an initial telephone session with a social worker specializing in geriatrics (six interventionists total), which is considered standard of care. The participant then completed four follow-up telephone sessions, which ranged from 15–30 minutes. These sessions focused on checking in regarding patient progress on goals and plans set in the initial assessment, as well as general supportive psychotherapy.

Training and Supervision.

CARE-Express interventionists were experienced writing mentors in the MSK Visible Ink program, a one-on-one writing program for MSK patients designed to promote self-expression and personal growth. The writing mentors in this program are required to have a strong writing background and undergo orientation and training, which consists of seminars, brainstorming sessions, and meetings with experts in patient care³⁷. Interventionists received the following training to deliver the CARE-Express intervention.: 1) review of the manual with a study investigator; 2) observation of multiple cases; and 3) completion of 1–2 “mock” cases, reviewed by a study investigator. CARE-Express interventionists received weekly supervision for the first six months of their involvement with the study, followed by monthly supervision meetings for the remainder of the study. The ESWC interventionists were social workers that specialized in geriatrics. Supervision with the primary social worker at MSK was completed weekly.

Outcomes.

Leon, Davis, & Kraemer’s criteria for demonstrating feasibility in a pilot study were utilized to measure the feasibility of CARE-Express, the primary outcome of this pilot study³⁸. This was determined by rates of acceptance (proportion of those contacted who are interested in participation), eligibility (percent eligible of those screened for eligibility), retention (number of participants who completed sessions), assessment process (proportion of completed assessments of planned assessments), and treatment fidelity (percentage of session content covered by interventionists).

The benchmark for retention and assessment was 80%, such that if 80% of participants complete all sessions and assessments, then feasibility is demonstrated. Treatment fidelity monitoring was completed by an RA and utilized a standardized adherence checklist to evaluate material adherence for 20% of participants in each intervention arm. Fidelity scores range from 0 to 100% adherence, and a fidelity score of 80–100% is considered high fidelity³⁹.

Determining the preliminary efficacy of CARE-Express on several psychosocial variables was the second aim of this study. The primary psychosocial variables were depression and anxiety, assessed with the HADS³⁴, with higher scores indicating more severe symptoms^32–34. Additional psychosocial variables included: demoralization (Demoralization Scale; higher scores indicating worse symptoms⁴⁰), coping (3 out of 15 subscales from the COPE Inventory; higher scores indicating better coping⁴¹), spiritual well-being (FACIT-Sp-12 Spiritual Well-Being Scale; higher scores indicating better well-being^42,43) and loneliness (UCLA Loneliness Scale - Short Form; higher scores indicating worse symptoms⁴⁴).

Statistical Analyses.

Descriptive analyses were used to describe rates of eligibility, acceptance, retention, assessment, and fidelity in the CARE-Express group. Since this was a pilot study with a primary aim to determine feasibility, the study was not powered to determine significant differences in the psychosocial variables between the intervention and control groups. Rather, the study was designed to provide estimates of effect size for preliminary efficacy. With a planned 59 participants with baseline data, the study had 50% power to detect a moderate effect size of d=0.50 with a 5% type I error rate and 80% power to detect a large effect of at least d=0.74. To examine differences in the psychosocial outcomes by group (i.e., CARE-Express vs. ESWC), both significance levels and standardized effect sizes (Cohen’s d; d=0.2, small; d=0.5, medium; and d=0.8, large effect) are reported. Prior to analyses, the CARE-Express and ESWC study participants were compared for significant differences on baseline demographic, disease, and psychosocial characteristics using a series of Chi-square and independent samples t-tests for categorical and continuous variables, respectively. Then, regression models of each change score, adjusting for baseline value of the outcome, were used to estimate differences in the psychosocial variables by intervention arm with group assignment predicting the post-intervention and four months post-study enrollment scores, separately. Statistical analyses were conducted in SAS.

Results

Participants

Of the 71 participants who consented to the study (CARE-Express n=41; ESWC n=30), 61 completed the baseline assessment, 2 of which were excluded from data analysis, resulting in 59 evaluable baselines (CARE-Express n=30; ESWC n=29) (Figure 1). Participants for ESWC (i.e., historical control) were recruited between December 2009 and September 2013; participants for CARE-Express were recruited between November 2014 and October 2019. Baseline patient characteristics, by intervention arm, are provided in Table 2. The CARE-Express and ESWC groups did not vary significantly on baseline characteristics.

Figure 1.

Modified CONSORT Diagram, Non-randomized study

Note. LTFU=Lost to follow-up.

Table 2.

Patient baseline characteristics

	All, (n=59) mean (SD)	CARE-Express, (n=30) mean (SD)	Control, (n=29) mean (SD)	p
Age (n=58)	75.3 (4.7)	74.5 (5.1)	76.1 (4.3)	0.19
Gender, % Female	66%	73%	59%	0.23
Ethnicity, % Hispanic	5%	3%	7%	0.61
Race, %
White	93%	90%	97%	0.37
Black	3%	3%	3%
Other	3%	7%	0%
Marital Status, %
Married/Living with partner	56%	53%	59%	0.70
Single	14%	10%	17%
Divorced/Separated	14%	17%	10%
Widowed	17%	20%	14%
Education, % College	68%	57%	79%	0.06
Employed, % Retired	85%	87%	83%	0.68
Annual Income
< $40k	22%	17%	28%	0.51
$40k – $75k	27%	27%	28%
$75k – $150k	27%	33%	21%
> $150k	15%	13%	17%
Missing	8%	10%	7%
Psych History, % Yes	24%	27%	21%	0.59
Cancer Type, %
Breast	41%	53%	28%	0.24
Prostate	27%	20%	34%
Lung	8%	3%	14%
Gyn	17%	17%	17%
Lymphoma	7%	7%	7%
HADS: Total (n=57)	11.3 (6.0)	10.9 (6.2)	11.6 (5.8)	0.63
HADS: Anxiety (n=57)	5.9 (3.5)	6.1 (3.8)	5.6 (3.1)	0.57
HADS: Depression (n=57)	5.4 (4.0)	4.7 (3.7)	6.0 (4.2)	0.23
UCLA Loneliness	15.1 (5.7)	15.2 (5.2)	15.0 (6.3)	0.91
Coping: Active	13.4 (2.3)	13.9 (2.2)	13.0 (2.4)	0.14
Coping: Behavioral Disengagement	7.0 (3.3)	6.9 (3.2)	7.1 (3.4)	0.89
Coping: Planning	14.0 (2.7)	14.4 (2.4)	13.5 (2.9)	0.19
Demoralization: Total	25.3 (15.6)	24.1 (15.9)	26.5 (15.4)	0.56
Demoralization: Loss of Meaning	3.8 (4.3)	3.5 (4.4)	4.0 (4.3)	0.71
Demoralization: Dysphoria	6.4 (3.8)	6.6 (3.6)	6.1 (4.1)	0.67
Demoralization: Disheartenment	7.5 (5.0)	6.8 (4.7)	8.2 (5.3)	0.28
Demoralization: Helplessness	3.8 (3.7)	3.7 (3.5)	3.9 (4.1)	0.84
Demoralization: Sense of Failure	3.9 (2.9)	3.5 (2.5)	4.3 (3.1)	0.30
FACIT-Sp-12: Total	32.8 (10.4)	33.7 (10.7)	31.9 (10.1)	0.53
FACIT-Sp-12: MP	23.8 (6.7)	24.2 (6.6)	23.3 (6.9)	0.63
FACIT-Sp-12: Faith	27.2 (16.1)	28.5 (15.6)	25.9 (16.7)	0.54

Care-Express: Cancer and Aging Reflections for Elders-Expressive Writing Intervention; HADS: Hospital Anxiety and Depression Scale; SD: Standard Deviation; FACIT-Sp-12: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being

Feasibility Outcomes

There were no adverse events reported throughout the course of the trial. In total, 211 patients who met initial eligibility criteria were spoken to directly about the CARE-Express arm of the study. Of those, 29% (n=62) agreed to be screened for participation in the study (i.e., rate of acceptance). Of those who agreed to be screened, 66% (n=41) met distress, depression, or anxiety eligibility criteria and were offered participation in the study (i.e. rate of eligibility), indicating a high eligibility rate among those who were interested in participation. Eleven participants withdrew or became ineligible prior to the start of the intervention.

Of the 30 participants who started the CARE-Express intervention, 90% (n=27) completed all sessions, indicating adequate retention per the a priori cut-off of 80% as a benchmark of feasibility. Seventy percent (n=21) of participants completed the post-intervention assessment and 63% (n=19) completed the last follow-up assessment (i.e., four-months post-study enrollment), indicating less than adequate assessment process per the a priori cut-off of 80% (Figure 1). Mean treatment fidelity was 97% for all sessions (range=76%−100%), exceeding the threshold of 80% as an indication of high fidelity.

Psychosocial Outcomes

At the post-intervention assessment (Table 3), CARE-Express participants reported lower HADS depression scores compared to ESWC participants (Cohen’s d=0.69, p=0.01). On the Demoralization scale, CARE-Express, compared to the ESWC, demonstrated a moderate effect for lower Total Demoralization scores (d=0.50, p=0.06), and important effect sizes for the Demoralization subscales ranging from d=0.26 to d=0.46, p=0.12 to p=0.28). A small/moderate effect was also demonstrated for overall Spiritual Wellbeing (d = 0.41, p = 0.07) on the FACIT-Sp-12, and both the Meaning/Peace (d=0.32, p=0.20) and the Faith subscales (d=0.35, p=0.07). On the COPE inventory, CARE-Express, compared to ESWC, demonstrated greater reductions in Behavioral Disengagement (d=0.44, p=0.06) while the ESWC demonstrated a small effect for Active Coping (d=0.21, p=0.31). Changes in HADS Anxiety (d=0.08), UCLA Loneliness (d=0.01), and other COPE subscales, were comparable between groups (Table 3).

Table 3.

Changes in outcomes, from Baseline to Post-intervention Assessment Changes in outcomes, from Baseline to Post-intervention Assessment (n = 48)

	CARE-Express, (n=21) mean (SD)	Control, (n=27) mean (SD)	t-test p-value	ANCOVA p-value	Cohen’s d
HADS: Total (n=45)	−0.7 (4.2)	0.9 (3.8)	0.22	0.16	0.38
HADS: Anxiety (n=45)	0.0 (3.1)	−0.2 (2.3)	0.78	0.74	0.08
HADS: Depression (n=45)	−0.7 (2.1)	1.1 (2.7)	0.03	0.01	0.69
UCLA Loneliness	0.0 (4.2)	0.0 (2.8)	0.98	0.93	0.01
Coping: Active	0.3 (1.3)	0.8 (2.8)	0.48	0.31	0.21
Coping: Behavioral Disengagement	−0.9 (1.7)	0.2 (3.1)	0.14	0.06	0.44
Coping: Planning	0.1 (1.3)	0.2 (2.7)	0.89	0.40	0.04
Demoralization: Total	−4.3 (7.7)	0.1 (9.6)	0.09	0.06	0.50
Demoralization: Loss of Meaning	−1.1 (2.6)	−0.2 (4.0)	0.36	0.28	0.27
Demoralization: Dysphoria	−1.0 (2.1)	−0.1 (1.8)	0.12	0.12	0.46
Demoralization: Disheartenment	−1.1 (3.2)	0.1 (4.0)	0.28	0.12	0.32
Demoralization: Helplessness	−0.7 (1.9)	0.0 (3.0)	0.37	0.35	0.26
Demoralization: Sense of Failure	−0.4 (1.6)	0.4 (3.0)	0.27	0.22	0.33
FACIT-Sp-12: Total	1.7 (6.1)	−0.8 (6.3)	0.17	0.07	0.41
FACIT-Sp-12: MP	0.6 (4.1)	−0.9 (4.9)	0.27	0.20	0.32
FACIT-Sp-12: Faith	3.3 (9.3)	0.2 (8.5)	0.24	0.07	0.35

Care-Express: Cancer and Aging Reflections for Elders-Expressive Writing Intervention; HADS: Hospital Anxiety and Depression Scale; SD: Standard Deviation; FACIT-Sp-12: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being

At four months post-study enrollment assessment, the differential effects of CARE-Express attenuated (Table 4). Small to moderate effects, in favor of CARE-Express, remained for HADS depression (d=0.24), the Demoralization subscales of loss of meaning (d=.31) and sense of failure (d=0.30), total Spiritual Wellbeing (d=0.27), and the Faith subscale of the FACIT-Sp-12 (d=.33). Figure 2 depicts longitudinal mean scores for each measure, by group, over time.

Table 4.

Changes in outcomes, from Baseline to four-months-post-study-enrollment Changes in outcomes, from Baseline to four months post-study enrollment (n = 41)

	CARE-Express, (n=19) mean (SD)	Control, (n=22) mean (SD)	t-test p-value	ANCOVA p-value	Cohen’s d
HADS: Total (n=38)	0.3 (3.4)	1.0 (4.2)	0.58	0.53	0.18
HADS: Anxiety (n=38)	0.3 (2.4)	0.5 (2.6)	0.86	0.84	0.06
HADS: Depression (n=38)	−0.1 (1.7)	0.5 (2.7)	0.46	0.31	0.24
UCLA Loneliness	0.2 (3.2)	0.0 (3.0)	0.84	0.85	0.07
Coping: Active	0.2 (1.4)	1.1 (2.6)	0.17	0.84	0.44
Coping: Behavioral Disengagement	−0.5 (1.6)	−0.3 (2.5)	0.74	0.61	0.11
Coping: Planning	0.4 (1.3)	0.6 (2.5)	0.76	0.79	0.10
Demoralization: Total	−2.3 (9.4)	−0.9 (10.5)	0.66	0.52	0.14
Demoralization: Loss of Meaning	−0.8 (2.5)	0.0 (2.9)	0.33	0.31	0.31
Demoralization: Dysphoria	−0.3 (2.0)	−0.6 (2.4)	0.69	0.62	0.13
Demoralization: Disheartenment	−0.2 (3.4)	−0.1 (3.2)	0.94	0.67	0.02
Demoralization: Helplessness	−0.5 (2.7)	−0.5 (2.9)	0.94	0.96	0.03
Demoralization: Sense of Failure	−0.5 (1.3)	0.2 (2.7)	0.34	0.27	0.30
FACIT-Sp-12: Total	1.3 (5.9)	−0.7 (8.3)	0.40	0.23	0.27
FACIT-Sp-12: MP	−0.3 (4.3)	−1.2 (6.1)	0.57	0.45	0.18
FACIT-Sp-12: Faith	4.8 (8.3)	1.6 (10.6)	0.30	0.16	0.33

Care-Express: Cancer and Aging Reflections for Elders-Expressive Writing Intervention; HADS: Hospital Anxiety and Depression Scale; SD: Standard Deviation; FACIT-Sp-12: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being

Figure 2.

Longitudinal mean scores for psychosocial variables, by group, over time

Note. BL=Baseline; FU1=Follow-up 1 (post-intervention assessment); FU2= Follow-up 2 (four-months-post-study-enrollment assessment).

Discussion

Despite a number of trials, the efficacy of EWI in cancer populations remains unclear. CARE is a novel psychotherapy intervention specifically designed to address the emotional distress of older cancer patients. CARE-Express was thoughtfully designed to tailor the existing CARE framework⁷ into an expressive writing format. The primary aim of this pilot study, which was to evaluate the acceptability, tolerability, and feasibility of CARE-Express, was supported. The intervention demonstrated adequate rates of acceptability, eligibility, and retention. The secondary aim, which was to determine preliminary efficacy of CARE-Express on several psychosocial variables, was partially achieved, with CARE-Express participants reporting lower depression and demoralization scores and higher spiritual well-being scores compared to the ESWC arm.

Of the patients approached for this study, 29% expressed interest in participation, which is only slightly lower than recruitment rates to similar EWI studies of cancer patients with no age restrictions^45–47. Given the nature of this intervention, we interpret this acceptance rate to be adequate, as we would not expect all patients to be interested in committing to a writing intervention. It is important to note that recruitment for this study was completed by sending an initial invitation letter, followed by a telephone call. We believe that acceptance rates would be higher with in-person recruitment. However, our previous work has shown that although in-person recruitment may yield higher initial acceptance rates, retention is worse compared to studies in which patients are approached by mail and telephone⁴⁸. The recruitment method was intentional, as we aimed to recruit without in-person contact in order to reach older adults who are homebound or have physical limitations. Future studies of CARE-Express will focus efforts on increasing the acceptance rate by better targeting recruitment materials and processes to engage these participants in this line of research.

The feasibility of the intervention was supported by the eligibility results, as 66% of participants that expressed interest in this study were deemed eligible for participation. Of note, only 73% of participants who enrolled to the study started sessions, indicating that some initial interest was lost as session scheduling was coordinated. Future iterations will take this into account, as it seems critical to schedule the first session before barriers (e.g., avoidance, scheduling conflicts, etc.) arise for patients.

The high retention rate (90%) of participants who completed all CARE-EWI sessions also supports its feasibility and highlights the efficacy of the flexible, telephone-delivery of this intervention. While assessment rates were slightly lower than projected (70% and 63% across time points), this could be due to specific barriers faced by this population such as treatment side effects and scheduling conflicts with medical appointments. High treatment fidelity (97%) demonstrates the feasibility of using trained writing mentors as interventionists. This particularly important, as CARE-Express can be administered without direct access to psychiatrists or psychologists, thus increasing its potential for dissemination.

The second aim of the study was to examine the preliminary effects of CARE-Express on psychosocial functioning. Though this pilot study was not powered for statistical significance, the results were promising. CARE-Express demonstrated encouraging trends in psychosocial outcomes relative to the ESWC, as CARE-Express participants reported reduced depression, behavioral disengagement, demoralization, and increased levels of meaning and faith compared to ESWC. It is common for effects to dissipate following the end of a behavioral or expressive writing intervention, as seen at the follow-up timepoint^7,23,49,50. Thus, future iterations of this study would potentially include booster sessions in order to maintain the gains made during the active intervention. The effects reported emerged when compared to an efficacious control group, which was run by experienced social workers who specialized in geriatrics and matched to CARE-Express for number of sessions. It is therefore likely that this control group was more comprehensive than standard of care. Thus, the results of this pilot study suggest that CARE-Express is a potentially feasible, efficacious, and accessible intervention for older adults with cancer.

Clinical Implications

CARE-Express is a novel intervention that integrates the efficacious developmental framework from CARE⁷ with the promising framework of an EWI. CARE-Express is designed specifically to address the unique needs of older adults with cancer via the mode of expressive writing, which has been suggested to improve mental and physical health via mechanisms such as emotional disinhibition, cognitive, adaptation, and emotional processing/exposure^14,16–18. It is hypothesized that the developmental framework adapted from the CARE intervention bolsters the efficacy of this novel EWI. It was purposefully tested via telephone to demonstrate feasibility in reaching older adults with cancer who may face greater barriers when attending in-person appointments. An EWI may be of specific benefit to older patients with cancer as declines in physical functioning may limit initiation of adaptive coping strategies (e.g. exercise, social engagement) and the ability to travel to in-person psychotherapy appointments. Telephone-delivery of this intervention is especially important during the COVID-19 pandemic, as both older adults and patients with cancer are at an increased risk of severe illness during this time⁵¹. The use of writing interventionists to deliver this intervention also highlights the potential for peers without rigorous psychological training to deliver interventions with psychological benefits. Given the shortage and poor distribution of mental health professionals in the United States⁵², the ability to train peer or writing mentors to deliver structured and tested interventions has positive accessibility benefits.

Study Limitations

While feasibility and preliminary psychological effects were reported, there are some limitations to interpretability. First, the generalizability of these effects is limited, as our sample was predominately female, White, non-Hispanic, and college-educated. A future study will include a more diverse sample (e.g., race, ethnicity, education level, and gender). It is also possible that there may have been a selection bias in who enrolled in this study, as suggested by the homogeneity of the sample. The generalizability of these results is also limited by the fact that this was not an RCT, as CARE-Express was compared to a historic control group.

Conclusions

These pilot data suggest CARE-Express could be feasibly delivered by trained writing mentors and provides support that CARE-Express impacts important psychosocial variables for older adults with cancer. This intervention is unique in that it draws from two hypothesized efficacious interventions: the developmental themes of CARE and the format of an EWI. The flexible, telephone-delivery of CARE-Express results in high accessibility, which is of particular importance when caring for this population. Taken together, the results of this pilot study support the development of a future, sufficiently powered RCT with a more diverse sample to evaluate the efficacy of CARE-EWI.

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Availability of data and materials

Data and materials are available upon request.