Abstract
Purpose:
To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivor (RBCS) in which education was delivered early or after the support component.
Methods:
Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S), and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study - Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods.
Results:
Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (Mean (Standard deviation): SF-36 PCS: 44.88 (10.6) vs. 45.08 (10.6) ; MCS: 49.45 (11.1) vs. 48.1 (11.9); CES-D: 10.11 (9.8) vs. 10.86 (10.5) ; POMS-SF: 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS: 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen’s d −0.22, 95% CI: −0.38, −0.06) and POMS (Cohen’s d 0.23, 95% CI: 0.07, 0.39) for EE-S vs. S-DE.
Conclusions:
The implementation strategies were equivalent.
Implications for survivors:
Enhancing support may be considered before delivering not-in-person interventions to RBCS.
Keywords: breast cancer, neoplasm, cancer survivorship, rural health, implementation, quality of life
BACKGROUND
An estimated 16.9 million cancer survivors were living in the US as of January 2019.1 Due to improved treatment, detection, and the increasing aging population this number is projected to exceed 22 million by January 1, 2030.1 Breast cancer survivors represent the greatest number of female cancer survivors.1 Cancer survivorship research has progressed from initial reports about changes in quality of life (QOL) to efficacious interventions that improve QOL and health outcomes.2 However, the majority of interventions and programs remain clustered in large acute care cancer settings.3, 4 Thus, there is urgent need to translate interventions into community settings, particularly for rural populations. While many factors contribute to disparities in cancer outcomes, simply living in rural America is a major one. About 15% of the US population live in rural areas reporting poorer QOL, mental health, and access to healthy lifestyle choices.5–8 Geographic isolation and difficult travel contribute to inequity in access to survivorship care and potentially physical well-being and general quality of life. In an effort to address access barriers to survivorship education and support for survivors living in rural settings, the authors developed the Rural Breast Cancer Survivors (RBCS) Intervention, an intervention based on a previously validated program called the Breast Cancer Education Intervention (BCEi). The BCEi was an educational and support intervention delivered face to face, that demonstrated improved QOL outcomes among early-stage breast cancer survivors in a randomized trial.9 The BCEi became the basis for a breast cancer survivorship care model emphasizing self-management of treatment late effects, psychosocial changes, financial burden, and follow-up care.10, 11 Additionally, the BCEi was named one of the first evidence-based cancer control interventions in cancer survivorship by the National Cancer Institute’s Research-Tested Intervention Programs (RTIPS).12
To reach survivors from rural areas, the RBCS intervention was delivered entirely over the phone, with written materials mailed to participants. Telephone communication remains the telehealth vehicle having the greatest potential to reach the largest proportion of at risk populations.13–17 Telephones can be a low cost and low-tech solution for underserved rural residents while providing flexibility in teaching a wide range of behavioral interventions.13–16 More than 95% of rural households use the telephone and older residents are particularly dependent on this method of communication.18 Our previous research found that without technologically supported communication, RBCS with limited geographic access were consistently unable to participate in interventions delivered at an academic healthcare center.9, 10, 19 However, the impersonal nature of the telephone interaction compared to an in-person interaction may hinder engagement in the intervention. 17 The RBCS intervention extended the BCEi from follow up time from 6 months to one year and was delivered in two ways: one where the educational component was delivered first (Early Education and Support), and one where it was delivered after establishing support by the interventionist (Support and Delayed Education). The hypothesis was that Early Education and Support would benefit RBCS more than delaying the needed education in the transition period from treatment to survivorship.20 The purpose of this paper is to report the findings of the evaluation of these two implementation strategies on QOL outcomes.
METHODS
We conducted a randomized controlled trial (RCT) with RBCS to compare two implementation strategies for the RBCS intervention, i.e., Early Education and Support (EE-S) and Support and Delayed Education (S-DE). Prior to study initiation, the principal investigator received approval from the university’s IRB (070905016), the Florida Department of Health IRB, and the Florida Cancer Data System (FCDS), which maintains the state cancer registry.
Procedures
Participants:
Breast cancer survivors are defined as women with a history of breast cancer.21 Because the RBCS intervention was designed for survivors transitioning off the primary treatment setting, we restricted enrollment to women within the first 3 years of completing primary treatment. Other eligibility criteria included women 21 and older diagnosed with Stage 0-III breast cancer, living in rural Florida, and with telephone access. Survivors receiving anti-hormonal therapy or anti-HER2 treatment were also eligible. Survivors with metastatic disease, men with a breast cancer diagnosis, and no phone access were excluded from participation. Residence in rural Florida was based on two criteria: residence in one of 33 Florida rural counties designated by 2000 Florida statute; or residence in a rural pocket of the 34 urban counties with an Index of Research Access (IRA) score equal to or greater than 4.22, 23 As we previously reported,23 the IRA was particularly suitable for recruitment in counties with pockets of high and low density or physical barriers to access, and provides a granular determination of rurality at the census-track level of precision.23 Additionally, by estimating travel time, the IRA also accommodates physical barriers to access
The recruitment goal was 440 participants randomly split between each of two groups, EE-S or S-DE. This design also allowed to examine the effects of education alone versus attention control in the first 6 months of participation. The sample size was determined based on 20% attrition and 80% statistical power to detect a time-averaged standardized difference of 0.28,9 assuming an intra-subject correlation of 0.5 across five time-points and Type I error level of 0.01.24 The target effect size allows detection of minimal clinically important differences on main outcomes (standardized difference ≥ 0.3).
Recruitment:
Recruitment consisted of approved use of state cancer registry combined with active recruitment strategies.25 Annually, the authors received breast cancer cases within the prior year from the FCDS. These were reviewed to include residents of all rural counties, and residents of rural pockets in urban counties having an IRA >4.23 RBCS could receive up to three contacts: first, a letter of invitation, a second letter for non-response, and a telephone call for non-response to either letter. Survivors responded with their interest via mail or telephone call to a toll-free land line, and those who agreed to participate provided written informed consent via mail. Those who declined were removed from the list to prevent further contact.25
RBCS Intervention:
The intervention was delivered completely via telephone and mail. Over 12 months, participants received 4 components: intake assessment; 3 education sessions; one educational follow-up session; and 6 support calls. The two RCT groups differed in the timing of the education sessions which started in Month 1 for the EE-S group, and in month 7 for the S-DE group. Supplemental written materials were mailed to participants and enhanced teaching and learning activities.
The intake assessment established contact and engaged rural participants whom had never met face to face with the interventionists. The intake and data collection generally took about 1 hour.26 In the three education sessions, interventionists reviewed the RBCS Education Manual totaling 140 pages and 38 Tip Sheets of strategies for symptom self-management. The first two calls took on average about 50 minutes, and the third one about 40 minutes.26 The first half of each session focused on teaching while the latter half was tailored to the participant’s needs. During session one, the interventionist educated survivors about physical cancer late effects including fatigue, lymphedema, and pain. In session two, the interventionist reviewed ways to promote healthy lifestyle behaviors and discussed physical changes such as menopausal symptoms including risk of heart disease and bone loss. Additionally, family and social relationships, work, financial, and insurance challenges were discussed. Session three explored psychological late effects including anxiety, depression, fear of recurrence, faith, and spiritual changes.
The educational follow-up session, lasting about 25 minutes,26 was designed to evaluate and reinforce learning about self-management, psychosocial concerns, cancer surveillance, and health and wellness activities. Support calls were unstructured and enabled continued contact, establishment of trust and took on average about 43 minutes.26 Participants were encouraged to voice concerns about their survivorship experience and talk with the interventionist about their lives after cancer.
Interventionists:
The RBCS interventionists were two full-time and two part-time research nurses. Two had master’s degrees, one had a baccalaureate degree, and one had a diploma in nursing. All had clinical experience in women’s health, and three of them had clinical experience specific to breast and women’s cancers. Interventionists received two days of training from the research coordinator and the principal investigator (KM) in cancer survivorship, rural and health disparities, telephone intervention delivery and intervention fidelity. Training included didactic instruction, role playing, and intensive review of the study policies and procedures. In addition, monitoring occurred for the first 2–3 intervention phone calls delivered. Interventionists delivered the interventions across the RCT arms. However, contamination across RCT arms was minimized because interventionists were familiar with the structured educational content and would not deliver it during the initial support calls in the S-DE group. Moreover, interventionists were assigned randomly to participants and participated in weekly meetings with the principal investigator to discuss issues and/or challenges that arose during intervention delivery. Intervention calls were recorded to monitor for intervention integrity.
Main Outcomes
The main outcomes included physical and mental health, QOL, depressive and mood symptoms, and social support. Participants completed self-reported outcomes at baseline and every 3 months for 12 months, totaling 5 time points. In addition to demographic and cancer treatment data were collected. Each assessment took approximately one hour to complete. Outcomes were obtained using the same procedure and instruments on both groups. All outcome data are reported.
Physical and mental health was assessed using the two composite scores of the Short-Form 36 Health Survey (SF-36), a measure of self-reported health status.27 Scores range from 0 to 100, where higher scores indicate better physical and mental well-being. A score of 50 indicates a level comparable to the average U.S. adult. At baseline, the physical and mental health composite scales had alpha reliability of .93 and .90 respectively.
QOL data were collected using the 48-item QOL-Breast Cancer Survivors survey. This survey has an overall score and three QOL sub-domain scores: physical, psychological, and social.28 Scores range from 0 to 10, with higher scores indicating poorer QOL. At baseline, Cronbach’s alpha was estimated at .95. The overall score was used in this study.
Depressive symptoms were measured using the Centers for Epidemiologic Studies Depression Scale (CES-D), a self-report scale designed to measure depressive symptoms in the general population.29 Scores range from 0 to 60, where higher scores indicate increased depressive symptoms. In our sample, the CES-D had Cronbach alpha of .91 at baseline.
Mood states were assessed using the Profile of Mood States-Short Form (POMS-SF). This 37-item scale assesses overall mood and transient mood changes in six identified moods or affective states: tension, depression, anger, vigor, fatigue, and confusion.30, 31 Scores range from −32 to 200, where higher scores indicate higher mood disturbance. At baseline, Cronbach’s alpha reliability for the total mood disturbance scale was .96.
Social support data were collected using the Medical Outcomes Study - Social Support Survey (MOS-SSS), a 19-item survey assessing dimensions of social support.32 The MOS-SSS contains four functional support subscales and an overall functional social support index. Scores range from 0 to 100, where higher scores indicate better perceived social support. At baseline, the MOS-SSS overall support index had Cronbach’s alpha of .96.
Demographic and cancer treatment characteristics were collected using the 32-item Breast Cancer Survivor Sociodemographic and Treatment Survey used in prior studies by the investigators.9
Statistical Methods
Baseline socio-demographic and treatment characteristics, QOL, physical and mental health, mood, depression, and social support scales were examined using measures of effect size (Cohen’s d or Cramer’s V) for balance between groups. Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods. First, using fitted models, mean differences between groups at each time point were estimated and tested. Second, differences in average change from baseline between groups for the initial 6 months (before initiation of education of the delayed group) and for the entire 12-months were estimated and tested. Computation of standardized mean differences (using baseline standard deviations) for each outcome facilitated interpretation across scales.
Because we found an association between baseline levels of self-reported mental health (SF-36 mental health composite score) and attrition,33 we mitigated the impact of missing data by using linear mixed models and by adjusting the models for baseline SF-36 mental health composite scores (i.e., including the score as a covariate). A Benjamini-Hochberg False Discovery Rate adjustment was used to control for false positives among the 44 between-group inferences conducted on study outcomes. Analyses were conducted using SAS v9.4 statistical software.34, 35
RESULTS
Figure 1 provides CONSORT details. Overall, 4,939 RBCS were contacted. A total of 655 (13.3%) responded with interest, of which 432 (66.0%) subsequently enrolled in the RBCS study, and 223 could not be contacted again. Among those who enrolled, RBCS resided in 63 (93%) of the 67 Florida counties. Of the 432 RBCS enrolled, 332 were retained at the end of the 12-month study: the overall compliance at 12 months was 77%, and attrition was 23%.33 By RCT arm, compliance was 80% in the EE-S, and 72.8% in the S-DE. However, attrition (20% vs 27.2%) was not significantly associated with RCT arm.33 Attrition was mainly due to participant dropout, only 2 women died during the course of the study.
FIGURE 1: RBCS CONSORT FLOW CHART.
EE-S = Early Education and Support; S-DE= Support and Delayed Education
Table 1 lists the characteristics of the participants. There were no relevant differences between the two groups (EE-S and S-DE) in age, marital status, education, employment or family income. About 48% were 65 years or older, 73.1% were married or partnered, 28% had high school education or less, 45.8% were retired, and 30.3% reported family income of ≤$20,000. There were no relevant differences between the groups in type of surgery, chemotherapy, radiation therapy, or hormonal therapy. Overall, participants received standard breast cancer treatment with the majority receiving lumpectomy and radiation therapy for control of local disease, and chemotherapy for control of systemic disease. More than 66% received hormonal therapy. Average time since diagnosis to study entry was 25.6 months (SD=7.9) with an average time since completion of primary breast cancer treatment of 18.8 months (SD=7.9).
Table 1.
Demographic, Clinical, and Socioeconomic Characteristics by Group Assignment of 432 Breast Cancer Survivors Participating in the Rural Breast Cancer Survivor (RBCS) Intervention Study.
| Characteristic | Early Education and Support (n=215) | Support and Delayed Education (n=217) | Cramer’s V |
|---|---|---|---|
| n (%) | n (%) | ||
| Demographic characteristics | |||
| Age groups | 0.01 | ||
| 35–45 | 8 (3.7) | 7 (3.2) | |
| 46–64 | 104 (48.4) | 107 (49.3) | |
| 65–90 | 103 (47.9) | 103 (47.5) | |
| Marital status | 0.06 | ||
| Never married | 3 (1.4) | 7 (3.2) | |
| Married or living w/ partner | 161 (74.9) | 155 (71.4) | |
| Separated / divorced/ widowed | 51 (23.7) | 55 (25.3) | |
| Minority | 15 (7) | 10 (4.6) | 0.05 |
| Clinical Characteristics | |||
| Months since end of treatment a | 0.06 | ||
| <=12 | 39 (18.5) | 49 (23.1) | |
| 13–24 | 123 (58.3) | 113 (53.3) | |
| 25+ | 49 (23.2) | 50 (23.6) | |
| Surgery received | 0.03 | ||
| Lumpectomy | 124 (57.7) | 123 (56.7) | |
| Mastectomy | 61 (28.4) | 67 (30.9) | |
| Bilateral Mastectomy | 30 (14) | 27 (12.4) | |
| Chemotherapy | 134 (62.3) | 116 (53.5) | 0.09 |
| Radiation | 154 (71.6) | 151 (69.6) | 0.02 |
| Hormonal therapy b | 147 (68.4) | 140 (64.5) | 0.04 |
| Treatment mix | 0.09 | ||
| Surgery only | 25 (11.6) | 35 (16.1) | |
| Surgery, chemotherapy | 36 (16.7) | 31 (14.3) | |
| Surgery, radiation | 56 (26) | 66 (30.4) | |
| Surgery, chemo, radiation | 98 (45.6) | 85 (39.2) | |
| Socioeconomic characteristics | |||
| Education | 0.08 | ||
| < High school | 11 (5.1) | 13 (6) | |
| High school grad. | 56 (26) | 41 (18.9) | |
| Technical school /some college | 73 (34) | 76 (35) | |
| Completed college | 48 (22.3) | 56 (25.8) | |
| Postgraduate | 27 (12.6) | 31 (14.3) | |
| Support services c | 54 (25.1) | 44 (20.3) | 0.06 |
| Employment status | 0.09 | ||
| Full-time | 51 (23.7) | 60 (27.6) | |
| Part-time | 35 (16.3) | 27 (12.4) | |
| Retired | 96 (44.7) | 100 (46.1) | |
| Homemaker | 12 (5.6) | 12 (5.5) | |
| Other | 21 (9.8) | 18 (8.3) | |
| Family income | 0.12 | ||
| $20,000 or less | 32 (14.9) | 39 (18) | |
| $20,001 to $30,000 | 28 (13) | 32 (14.7) | |
| $30,001 to $40,000 | 16 (7.4) | 18 (8.3) | |
| $40,001 to $50,000 | 22 (10.2) | 24 (11.1) | |
| Greater than $50,000 | 76 (35.3) | 81 (37.3) | |
| Declined to answer | 41(19.1) | 23 (10.6) | |
| Health insurance | 203 (94.4) | 205 (94.5) | 0.00 |
| Dropped out | 41 (19.1) | 59 (27.2) | 0.10 |
n=9 women did not provide end of treatment date
On hormonal treatment at the time the data were collected
Cancer support groups, counseling, support websites
Table 2 shows descriptive statistics for the study outcomes at baseline. No imbalances between the two randomized study groups were found. On average, participants had lower levels of self-reported physical health compared with the general population score of 50 (44.9, SD 10.6 for EE-S, and 45.08, SD 10.64 for S-DE). Mental health composite scores were similar to the general population (49.45, SD 11.14 for EE-S, and 48.1, SD 11.86 for S-DE). Overall quality of life scores were, on average, at around 70% of the best possible score. CES-D scores were greater than 10 in both groups indicative of mild to moderate depressive symptomatology. About 25% of participants had CES-D scores greater than 16 indicative of depressive symptoms. However, the highest scores were in the range of 49–53 indicating high risk of clinically relevant depressive symptoms. Overall social support scores were high about 80% of the best possible score. Total mood disturbance scores were, on average, at about 22% of the maximum possible score.
Table 2.
Baseline Comparison of Study Outcomes by Group Assignment
| Outcome scales and subscales | Early Education and Support (n=215) | Support and Delayed Education (n=217) | Cohen’s d† | ||
|---|---|---|---|---|---|
| Mean (SD) | Min. - Max. | Mean (SD) | Min. - Max. | ||
| SF-36 Physical health composite | 44.88 (10.6) | 17.45 – 64.98 | 45.08 (10.64) | 18.01 – 66.91 | −0.02 |
| SF-36 Mental health composite | 49.45 (11.14) | 12.47 – 69.67 | 48.1 (11.86) | 15 – 69.72 | 0.12 |
| Overall Quality of Life | 3.16 (1.58) | 0.26 – 7.96 | 3.12 (1.52) | 0.5 – 7.62 | 0.03 |
| Depression CESD | 10.11 (9.76) | 0–49 | 10.86 (10.55) | 0 – 53 | −0.07 |
| MOS - Overall Social Support | 79.6 (21.19) | 17.11 – 100 | 78.66 (21.16) | 11.84 – 100 | 0.04 |
| POMS - Total Mood Disturbance | 23.95 (38.64) | −32 – 167 | 26.35 (38.77) | −32 – 152 | −0.06 |
Notes:
Early Education and Support minus Support and Delayed Education
Table 3 shows the model-predicted means by group and time point for the study outcomes. The observed effect sizes were small and no single between-group difference p-value crossed a 10% False Discovery Rate threshold. Suggestions of differences were observed at month nine in the SF-36 mental health composite scores and the POMS total mood disturbance score, with slightly better mean scores for the delayed education group compared to the early education group.
Table 3.
Model-estimated Outcome Means by Group and Time-Point
| Outcome scales/ Month | Early Education and Support | Support and Delayed Education | Difference* | |||
|---|---|---|---|---|---|---|
| Mean (SE) | Mean (SE) | Mean (SE) | P | Cohen’s d† (95% CI) | ||
| SF-36 Physical composite score | ||||||
| 0 | 44.91 (0.72) | 45.29 (0.73) | −0.38 (1.03) | 0.710 | −0.04 (−0.23, 0.15) | |
| 3 | 45.55 (0.75) | 46.24 (0.75) | −0.68 (1.06) | 0.520 | −0.06 (−0.26, 0.14) | |
| 6 | 46.03 (0.76) | 46.51 (0.76) | −0.48 (1.08) | 0.657 | −0.05 (−0.25, 0.15) | |
| 9 | 46.33 (0.77) | 46.95 (0.82) | −0.62 (1.13) | 0.583 | −0.06 (−0.27, 0.15) | |
| 12 | 46.11 (0.75) | 46.89 (0.77) | −0.78 (1.08) | 0.471 | −0.07 (−0.27, 0.13) | |
| SF-36 Mental composite score | ||||||
| 0 | 49.57 (0.52) | 49.21 (0.52) | 0.37 (0.74) | 0.618 | 0.03 (−0.1, 0.16) | |
| 3 | 51.4 (0.56) | 51.13 (0.56) | 0.27 (0.79) | 0.738 | 0.02 (−0.11, 0.15) | |
| 6 | 50.49 (0.59) | 51.3 (0.58) | −0.81 (0.83) | 0.329 | −0.07 (−0.21, 0.07) | |
| 9 | 49.86 (0.61) | 52.36 (0.69) | −2.49 (0.92) | 0.007 | −0.22 (−0.38, −0.06) | |
| 12 | 50.78 (0.57) | 51.75 (0.6) | −0.97 (0.83) | 0.244 | −0.08 (−0.22, 0.06) | |
| Overall Quality of Life | ||||||
| 0 | 3.14 (0.08) | 3.01 (0.08) | 0.13 (0.11) | 0.257 | 0.08 (−0.06, 0.22) | |
| 3 | 2.97 (0.08) | 2.89 (0.08) | 0.09 (0.12) | 0.466 | 0.06 (−0.09, 0.21) | |
| 6 | 2.99 (0.08) | 2.83 (0.08) | 0.15 (0.12) | 0.204 | 0.1 (−0.05, 0.25) | |
| 9 | 3.01 (0.08) | 2.75 (0.09) | 0.27 (0.12) | 0.031 | 0.17 (0.02, 0.32) | |
| 12 | 2.89 (0.08) | 2.67 (0.08) | 0.23 (0.12) | 0.055 | 0.15 (0, 0.3) | |
| Depression CES-D | ||||||
| 0 | 9.99 (0.49) | 10.04 (0.49) | −0.05 (0.7) | 0.944 | 0 (−0.14, 0.14) | |
| 3 | 10.02 (0.52) | 9.33 (0.52) | 0.69 (0.74) | 0.350 | 0.07 (−0.07, 0.21) | |
| 6 | 9.68 (0.54) | 8.36 (0.54) | 1.33 (0.76) | 0.082 | 0.13 (−0.02, 0.28) | |
| 9 | 9.67 (0.56) | 8.34 (0.61) | 1.34 (0.83) | 0.107 | 0.13 (−0.03, 0.29) | |
| 12 | 9.61 (0.53) | 8.68 (0.55) | 0.93 (0.76) | 0.225 | 0.09 (−0.06, 0.24) | |
| MOS - Social Support Survey | ||||||
| 0 | 79.74 (1.29) | 79.78 (1.3) | −0.04 (1.83) | 0.982 | 0 (−0.17, 0.17) | |
| 3 | 80.39 (1.34) | 80.61 (1.34) | −0.22 (1.89) | 0.909 | −0.01 (−0.19, 0.17) | |
| 6 | 82.33 (1.36) | 80.5 (1.36) | 1.83 (1.93) | 0.342 | 0.09 (−0.09, 0.27) | |
| 9 | 82.8 (1.38) | 82.16 (1.46) | 0.63 (2.02) | 0.754 | 0.03 (−0.16, 0.22) | |
| 12 | 83.29 (1.35) | 83.51 (1.38) | −0.22 (1.93) | 0.910 | −0.01 (−0.19, 0.17) | |
| POMS-SF - Total Mood Disturbance | ||||||
| 0 | 23.58 (1.88) | 23.23 (1.88) | 0.35 (2.66) | 0.895 | 0.01 (−0.12, 0.14) | |
| 3 | 22.12 (1.98) | 17.34 (1.99) | 4.79 (2.8) | 0.088 | 0.12 (−0.02, 0.26) | |
| 6 | 22.32 (2.04) | 16.72 (2.04) | 5.6 (2.88) | 0.052 | 0.14 (−0.01, 0.29) | |
| 9 | 22.55 (2.1) | 13.8 (2.29) | 8.75 (3.11) | 0.005 | 0.23 (0.07, 0.39) | |
| 12 | 21.47 (2.01) | 15.79 (2.08) | 5.68 (2.9) | 0.050 | 0.15 (0, 0.3) | |
Notes: n at month 0, 3, 6, 9, and 12 in the Early Education and Support group: 215, 183, 166, 151, and 174; in the Support and Delayed Education group: 217, 184, 170, 116, and 158.
Early Education and Support minus Support and Delayed Education;
Cohen’s-d using baseline SD
Table 4 lists the estimated change from baseline within group for all outcomes by averaged across the initial 6 months as well as across all time-points post-baseline, and compares these changes between the study groups. The observed effect sizes within- and between-groups were small and no single between-group difference p-value crossed a 10% False Discovery Rate threshold.
Table 4.
Model-estimated Average Change from Baseline by 6 Months and 12 Months Post-baseline
| Outcome scales and time period | Average Change from Baseline | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Early Education | Delayed Education | Difference* | |||||||
| Mean (SE) | P | d† | Mean (SE) | P | d† | Mean (SE) | P | d† | |
| SF-36 Physical health composite | |||||||||
| By 6 Months | 0.78 (0.46) | 0.091 | 0.07 | 1.07 (0.46) | 0.02 | 0.1 | −0.29 (0.65) | 0.654 | −0.03 (−0.15, 0.09) |
| By 12 Months | 1.07 (0.43) | 0.012 | 0.1 | 1.3 (0.44) | 0.003 | 0.12 | −0.23 (0.61) | 0.708 | −0.02 (−0.13, 0.09) |
| SF-36 Mental health composite | |||||||||
| By 6 Months | 1.41 (0.54) | 0.01 | 0.12 | 1.99 (0.54) | <.001 | 0.17 | −0.58 (0.77) | 0.45 | −0.05 (−0.18, 0.08) |
| By 12 Months | 1.11 (0.53) | 0.038 | 0.1 | 2.34 (0.54) | <.001 | 0.2 | −1.23 (0.76) | 0.104 | −0.11 (−0.24, 0.02) |
| Overall Quality of Life | |||||||||
| By 6 Months | −0.17 (0.04) | <.001 | −0.11 | −0.15 (0.04) | 0.001 | −0.1 | −0.02 (0.06) | 0.774 | −0.01 (−0.09, 0.07) |
| By 12 Months | −0.18 (0.04) | <.001 | −0.11 | −0.22 (0.04) | <.001 | −0.14 | 0.04 (0.06) | 0.5174 | 0.03 (−0.05, 0.11) |
| Depression CESD | |||||||||
| By 6 Months | −0.16 (0.45) | 0.716 | −0.02 | −1.18 (0.45) | 0.009 | −0.12 | 1.02 (0.64) | 0.111 | 0.1 (−0.02, 0.22) |
| By 12 Months | −0.23 (0.41) | 0.571 | −0.02 | −1.3 (0.42) | 0.002 | −0.13 | 1.07 (0.58) | 0.068 | 0.11 (0, 0.22) |
| MOS - Overall Social Support | |||||||||
| By 6 Months | 1.64 (0.8) | 0.041 | 0.08 | 0.78 (0.8) | 0.332 | 0.04 | 0.86 (1.13) | 0.447 | 0.04 (−0.07, 0.15) |
| By 12 Months | 2.38 (0.75) | 0.002 | 0.11 | 1.76 (0.77) | 0.023 | 0.08 | 0.62 (1.08) | 0.5643 | 0.03 (−0.07, 0.13) |
| POMS - Total Mood Disturbance | |||||||||
| By 6 Months | −1.49 (1.57) | 0.342 | −0.04 | −6.2 (1.56) | <.001 | −0.16 | 4.71 (2.21) | 0.033 | 0.12 (0.01, 0.23) |
| By 12 Months | −1.49 (1.45) | 0.305 | −0.04 | −7.04 (1.48) | <.001 | −0.18 | 5.55 (2.07) | 0.008 | 0.14 (0.04, 0.24) |
Early Education and Support minus Support and Delayed Education;
Cohen’s-d using baseline SD
DISCUSSION
The telephone-delivered intervention reached RBCS in most Florida counties, suggesting that there are few, if any, idiosyncratic factors that are geographically based barriers to access and reach. The telephone adaptation of the BCEi allowed us to reach a broader RBCS population. Further, whether Education was delivered before or after Support calls made little difference in this group of survivors. However, potential better outcome trajectories in the Delayed Education group raise important considerations for implementation of survivorship interventions delivered via the phone without an in-person contact with the interventionist.
Patient-centered, health-literate care focused toward well-being, particularly for those who are underserved, is recognized by the Institute of Medicine.36, 37 The interventions tested here demonstrate how this care can be delivered effectively to one underserved and at-risk population of RBCS. The findings of our project are consistent with the first of RE-AIM principles (i.e., Reach, Effectiveness, Adoption, Implementation, and Maintenance) to evaluate efficacious programs and their potential for translation and implementation.38 RTIPs at the National Cancer Institute scored the BCEi program at 100% for Reach potential and 5.0 (scale 0–5) for dissemination capability.12 This study demonstrates that this potential was realized in the RBCS which reached survivors living in rural areas of Florida who would likely not be able to participate in person. Current dissemination and implementation science favors adaptation of experimentally proven interventions for subsequent evaluation with other target populations.39 Our findings contribute to the evidence showing that the telephone is a low cost, low tech, and efficient means to reach RBCS.
An important question we addressed was whether, in the absence of a face-to-face encounter with the nurse interventionist, it was better to deliver the education sessions immediately or after rapport was established with the support calls. We found that those in the Support and Delayed Education group reported slightly better QOL scores. Possibly, initial support improved the relationship between survivor and interventionist, which was an important aspect of the researcher’s retention strategies.25 Post-intervention, participants relayed how much they appreciated the support calls prior to the start of the formal educational sessions. Delaying education allowed the participant to share her understanding of post-treatment adherence to self-care. The focus on the patient’s wellbeing may have been much more comforting and important than the investigators initially realized.36 Once mutual goal setting and trust were established, the nurse interventionist served as the patient navigator and addressed the psychological, social, physical, and economic concerns leading to improved QOL. Maintaining rapport, despite not having met the research nurse in person, allowed for both patient engagement and activation, based on the principle of shared responsibility, which is associated with better outcomes because it is based on patient-centered care.40 A post-diagnosis oscillatory trajectory was considered wherein survivors could be more or less responsive to the provision of educational content at different times, while at the same time embracing the possibility that providing support and “safe-passage” through difficult times may remain extremely important.
We also learned more about the needs of RBCS. Participants reported poorer physical health compared to the general population. Previously, baseline data showed that the majority of our participants reported being overweight/obese (69%) and that a BMI >31 was significantly associated with poorer physical and mental health. 41 This supports reports of poor access to higher quality nutritious foods and physical activity among cancer survivors and highlights the need for future studies regarding survivors’ ability to obtain care for non-cancer morbidity.42 Depressive symptoms were similar to that of other breast cancer survivors, but higher than the general population, which may be influenced by co-morbidity and economic burden.43 RBCS reported high levels of social support especially tangible, affectionate and positive social interactions. Lower support was reported in the Emotional /Informational domain, however. Social support scores improved over time which may indicate a positive impact of the intervention on this important outcome.
The perspective that survivorship begins at diagnosis has gained attention. Thus, questions related not just to “what”, but to the optimal time for initiating support has taken on renewed importance. Accumulating data indicate that both support and education are required to equip survivors to develop self-care actions and responsibility for their own care. In essence, the care plan without care is meaningless. Possibly time (18.8 months) since completion of primary treatment in this study has limited the impact of this intervention, as self-management of treatment side effects may have already occurred. The BCEi was delivered immediately post primary cancer treatment while survivors were 6 months or more from completion of primary treatment and at least one-year post diagnosis. Future studies should examine the optimal timing after diagnosis for the implementation of support and education interventions like the BCEi.
Limitations
Limitations of the present study are noted. First, all data are self-reports and may be subject to information recall or social bias. However, patient reported outcomes, no matter how long ago the experience, are easily recalled. Second, the sample was primarily Caucasian. Despite the lack of racial and ethnic diversity, this rural sample reflective the demographics of the state of Florida, with racial and ethnic diversity confined to the large metropolitan areas. However, the current study adds to the limited data available for RBCS and highlights the continued unmet needs of this population.
CONCLUSION
While transition from treatment to survivorship continues to be a significant concern, certain factors create disparities. One of those factors involves place of residence and difficulty in accessing support services. Breast cancer survivors living in rural areas are at particular risk of not receiving adequate support. However, it is possible to reach rural survivors over the phone, as telephones are ubiquitous even in rural homes and potentially provide a means to address the disparity by assuring rural survivors receive necessary support services. Future studies can evaluate other telehealth interventions, reaching the patient where she is located rather than limiting access to acute care settings. When implementing telephone-based interventions it is important to consider whether initial rapport needs to be established before the presumed intervention is delivered. We use the term “presumed” in the prior sentence as an acknowledgement that the development of initial rapport could be an intervention itself. Future studies should establish whether in-person or telephone delivered interventions result in equivalent outcomes, as well as establish the optimal timing post-diagnosis for education and support interventions such as the BCEi.
Acknowledgments:
The authors thank our breast cancer survivor participants who gave generously of their time.
Funding source: The research described was supported by a grant RO1CA-120638–07 (PI: Meneses) from the National Cancer Institute. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
Footnotes
Publisher's Disclaimer: This Author Accepted Manuscript is a PDF file of a an unedited peer-reviewed manuscript that has been accepted for publication but has not been copyedited or corrected. The official version of record that is published in the journal is kept up to date and so may therefore differ from this version.
Informed consent: Informed consent was obtained from all individual participants included in the study.
Conflict of Interest: The authors report no conflict of interest.
Disclosure: The Florida Cancer Incidence Data used in this report were collected by the Florida Cancer Data System under contract with the Department of Health. The views expressed herein are solely those of the authors and do not necessarily reflect those of the Florida Department of Health.
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