Previous research indicates that younger women (i.e., ≤ 50) with breast carcinoma experience greater emotional distress than older women (i.e., > 50) and that coping style is significantly related to the psychosocial adjustment of women with this disease. The purpose of this study was to evaluate through a randomized controlled trial the effectiveness of a problem-solving training intervention designed to empower women with breast carcinoma to cope with a range of difficulties when diagnosed in mid-life.
The study population consisted of women aged 50 years or younger who had no prior history of breast carcinoma, were diagnosed with Stage I-IIIA tumors, and for whom a first course of chemotherapy had been initiated recently. The intervention consisted of two in-person and four telephone sessions with an oncology nurse who provided problem-solving skills training and informational materials to the women over a 12-week period. All subjects were assessed for physical and psychosocial adjustment through telephone and mailed surveys at baseline, at 4 –months, and at 8 months.
Of 183 eligible women, 164 participated (a 90% participation rate), 149 of whom completed the study (a 91% completion rate). The subjects had significantly lower unmet needs and better mental health at the 4-month assessment. The intervention significantly decreased the number and severity of difficulties experienced by women with average or good problem-solving skills at 8 months, but was not effective in alleviating or resolving the problems encountered by women with poor problem-solving skills, relative to the control group.
Breast carcinoma is currently the most common malignant neoplasm and the second leading cause of cancer death among women in the United States, comprising about one third of all cancer cases and one sixth of all cancer deaths in the female population in the year 2000.1 Although the majority of breast carcinoma cases occur in women older than 50, about 23% of diagnoses and 16% of deaths occur among women 50 years old and younger.2 Fortunately, because of earlier detection and improved treatment, the 5-year relative survival rate for localized breast carcinoma has increased from 72% in the 1940s to 96% today, with the highest gains among women in this younger age group.1, 3 Despite the decline in mortality rates, however, women with breast carcinoma experience greater emotional distress than patients with other medical conditions, with higher levels of anxiety and depression observed at 1 and 2 years postdiagnosis.4 Research has demonstrated that younger women with this disease experience greater psychosocial morbidity than their older counterparts.5–9
Like older women, many younger women with breast carcinoma experience a variety of treatment-related side effects. Surgical and adjuvant therapies may cause breast pain, skin irritation, hair loss, weight gain, bowel problems, fatigue, nausea, and vomiting.10–14 These symptoms may lead to functional limitations, requiring the need for assistance with daily activities, such as personal care, household tasks, and transportation.15, 16 Research suggests that the unmet need for assistance is higher among younger than among older women.17–19
In addition, the diagnosis and treatment of cancer in mid-life have ramifications that do not apply or may be less relevant to older women with this disease. For example, because chemotherapy is recommended for premenopausal women, treatment-induced estrogen changes can have serious long-term implications, including the early onset of menopause and infertility.20–22 Consequently, women who have not yet had children may find themselves deprived of this option. In addition, disfigurement from surgery can cause a number of psychosocial problems, such as poor body image, sexual dysfunction, and difficulty with intimate relationships. Because most women in mid-life are employed and are raising families, employment disruptions, role interruptions, and family difficulties are also likely to occur.23–26 Finally, the existential trauma of confronting a life-threatening illness “prematurely” may cause high levels of anxiety and depression, resulting in a significant and negative impact on the quality of life of many younger women with this disease.27–31
Given the multiplicity of problems that may confront women diagnosed with breast carcinoma in mid-life, we designed and implemented an intervention that emphasizes positive coping through problem-solving skills training combined with the dissemination of information necessary to use these skills effectively.32 Many authors have reported that coping style is related significantly to the physical and psychosocial adjustment of patients with breast carcinoma33–39 and that less effective problem solvers have more cancer-related difficulties and greater emotional distress.40, 41 Problem-solving therapy has been especially effective in the treatment of clinical depression and anxiety.42–44
The goal of this study was to adapt problem-solving therapy to an intervention designed specifically to empower younger women with breast carcinoma to cope with the problems and emotional difficulties that arise when the disease is diagnosed in mid-life. We also tested the effectiveness of this intervention in a randomized trial. We report the results of this trial, as well as the results of efficacy analyses that identify the subgroup of women most likely to benefit from this type of intervention.
MATERIALS AND METHODS
Eligibility and Recruitment
Study eligibility criteria included women age 50 or younger who had no history of breast carcinoma, who had a tissue-confirmed diagnosis of Stage I-IIIA tumors, and who were beginning their first course of chemotherapy treatment. Criteria were selected to ensure reasonable homogeneity in women's disease and treatment experience. For example, women with metastatic disease have a poorer prognosis and may be offered entirely different treatment protocols than women with earlier-stage disease.
Eligible patients were recruited between April 1996 and November 1999 from a network of sites in Rhode Island (31 private oncology practices and 4 hospital oncology departments), Massachusetts (two hospital oncology departments in southeastern Massachusetts), Pennsylvania (one university oncology clinic in Philadelphia), and New Jersey (two hospital oncology departments in Newark). The research protocol was reviewed and approved by Brown University and by the Institutional Review Board at each recruitment site. Medical oncologists and/or their office personnel provided information about the study to all eligible patients on an ongoing basis. Contact information for women interested in learning more about the research was then provided to project staff.
The recruitment process involved sending an advance letter from the principal investigator that described the study purpose and procedures. This was followed several days later by a telephone call from a research interviewer to answer patients' questions and invite participation. Women who agreed to participate were asked to complete a baseline telephone interview and mailed questionnaires. They were also asked to nominate a primary support person (PSP) to participate as a partner in the intervention. Nomination of a PSP was not required for patient participation in the trial. Nominated PSPs were then contacted by research staff to invite their participation and to complete similar surveys. Verbal informed consent to participate in the research was obtained from all women and their nominated PSPs before baseline telephone interviews were conducted.
Following ascertainment of PSP participation, women were randomized to control and experimental arms, stratified by recruitment site location (RI/MA, PA, NJ) and PSP status (one of three conditions: spouse or significant other; other family member or friend; no participating PSP). Stratification by PSP status enabled us to determine whether the effect of the intervention differed according to whether women had a “partner” who served as helper in the intervention, and if so, whether the partner was a spouse or significant other versus someone else. All women randomized to the experimental arm of the trial provided written informed consent to participate in the intervention before initiation.
The intervention model is based on extensive research on social problem solving, i.e., the cognitive and behavioral processes used to identify effective strategies for coping with problematic situations encountered in daily living. Studies indicate that good problem solvers are less likely than poor problem solvers to experience emotional distress and performance limitations when faced with a difficult issue, making them more effective in achieving resolution.40–46 Furthermore, people can be taught problem-solving skills in a therapeutic environment that they can then utilize on their own to cope effectively with stressful events, such as the diagnosis of a serious illness.47, 48
A “home care training” model consisting of six problem-solving skills training sessions and a comprehensive informational and instructional manual, the Home Care Guide for Women with Breast Cancer, was developed for this trial. Problem-solving skills training consists of the following five interacting components: 1) problem orientation is a motivational technique that includes viewing problems as an inevitable, normal, and predictable part of life that can be resolved effectively when confronted appropriately; 2) problem definition refers to the process of analyzing a problem, understanding what specifically makes the situation difficult, and establishing realistic goals for achieving resolution; 3) generation of alternatives involves brainstorming about the many possible ways to solve a problem; 4) decision-making is the process of evaluating each of the potential solutions to determine which one will meet the desired goal while minimizing negative consequences and maximizing positive outcomes; 5) solution implementation and verification involves developing a plan, carrying it out, and evaluating its success.49–51
The Home Care Guide for Women with Breast Cancer was adapted from the Home Care Guide for Cancer,32 an informational manual targeted to the family caregivers of advanced cancer patients.45, 46 In the trial's developmental phase, the Home Care Guide for Cancer was edited to meet the needs of the study population, i.e., women diagnosed with breast carcinoma in mid-life. Several chapters specific to the issues of advanced cancer patients were deleted and a number of new chapters were added. The deletion and addition of chapters were based on a series of focus groups conducted with women with breast carcinoma aged 50 and younger to identify the physical and psychosocial issues most salient to this population. Focus group participants ranged from several months to several years posttreatment. Among the new topics added to the Home Care Guide for Women with Breast Cancer were body image concerns, sexuality, family roles and relationships, coping strategies for children, interactions with medical care providers, and breast carcinoma survivorship. The manual is structured to parallel the problem-solving skills training steps, summarized by the following headings in each chapter: “Understanding the Problem,” “When to Get Professional Help, ” “What You Can Do,” “Possible Obstacles,” and “Carrying Out and Adjusting Your Plan.”
The intervention was administered by an oncology research nurse over the course of six sessions. The first in-person session was held in the patient's home or another convenient location and lasted approximately 2 hours. The interventionist provided an overview of the problem-solving skills training steps and explained how to use the manual as an information tool. Working with the participant and her support person (if nominated), the research nurse used problem-solving techniques to resolve several sample problems, using worksheets specifically designed for the step-by-step approach while referring to relevant manual chapters. Subjects then identified one or more of their own concerns and used problem-solving techniques and materials independently, with feedback from the interventionist. These exercises allowed participants to understand and internalize the training principles and enabled the interventionist to identify and address problem-solving barriers.
Four follow-up telephone contacts were conducted, each scheduled approximately 2 weeks apart, to reinforce the use of problem-solving techniques. Subjects were asked to complete worksheets on their own for additional problems that would be be discussed during the phone calls. Participants were also provided with a telephone number and encouraged to contact the nurse interventionist at any time to discuss additional questions or issues.
The final in-person session provided additional home care training while further developing patient independence. During this 2-hour session, the interventionist again reviewed problem-solving principles and techniques. However, she deliberately took a less active role to prepare the women and their PSPs for termination of the skills training program. The interventionist stressed the participants' ability to be effective problem solvers, the importance of maintaining a positive orientation, and the usefulness of intervention principles and materials as coping tools.
Schedule of Assessments
All participants were asked to complete follow-up assessments at approximately 4 months postbaseline, when the majority of women were expected to have completed treatment, and at 8 months postbaseline, as a distal measure of the intervention's effectiveness. Medical record abstraction was also conducted to obtain detailed information regarding the breast carcinoma diagnosis and treatment. After completion of all data collection, participants randomized to the control arm were invited to meet with an oncology nurse specialist for a one-time problem-solving skills home care training session focusing on breast carcinoma survivorship issues. Figure 1 provides an overview of the study protocol.
The following measures were selected as study outcomes to determine the effectiveness of the intervention in alleviating cancer-related problems and stressors. An exception is the Social Problem-Solving Inventory, which is employed as an independent variable in this study.
The Cancer Rehabilitation Evaluation System (CARES) is a self-report questionnaire designed to assess the rehabilitation needs and quality of life of people with cancer. Using a five-point scale, patients rate the degree to which a series of problem-oriented statements apply to their own experience during the past month. A global score as well as five subscale scores are calculated, which indicate the extent of problems encountered with physical (26 items), medical (11 items), psychological (44 items), sexual (8 items), and marital (18 items) issues. All indices are scored to create an “average severity rating,” i.e., the sum of the severity of problems divided by the total number of problems reported. Both global and subscale scores range from 0 to 4, with higher scores indicating greater difficulty.52 Psychometric test results indicate that the CARES scales are reliable and valid measures53, 54 and there are extensive normative CARES data on women with breast carcinoma.28, 34, 35, 55
Unmet need for assistance
To determine how subjects manage daily activities following their breast carcinoma diagnosis, they are asked to indicate whether they “needed help” with personal care (bathing, dressing, moving in and out of bed or chairs), meal preparation, housekeeping, shopping, transportation, and child care in the past month. Women who reported that they had help are asked to identify those who offered assistance. Those who responded that they had no help are considered to have unmet need. Women who received some help but reported that they needed additional help are also considered to have unmet need. This measurement technique has been used in studies of unmet need among patients undergoing treatment for cancer,15–17 as well as other health conditions.56–58
Mental Health Inventory
The MHI-5 is a five-item subscale of the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) that measures emotional distress. Weighted index scores range from 0 to 100 with higher values indicating better emotional health. This well-validated scale is widely used in research studies on a variety of populations.59–61
Impact of Events Scale
The IES assesses psychological reaction to potentially distressing events, such as the diagnosis of a serious illness.62 Responses to 15 items yield two subscales: intrusion (seven items, range = 0–35) and avoidance (eight items, range = 0–40), with higher scores indicating greater posttraumatic stress response. Intrusion measures subjects' experience of “unbidden thoughts and images, troubled dreams, strong pangs or waves of feelings, and repetitive behavior,” and avoidance reflects subjects' report of “ideational construction, denial of the meanings and consequences of the event, blunted sensation, behavioral inhibition or counterproductive activity, and awareness of emotional numbness.”63 The IES measures levels of distress experienced over time following a breast carcinoma diagnosis.64–68
Social Problem-Solving Inventory-Revised
The SPSI-R, a 52-item self-report revision of the original 70-item SPSI,69 measures people's ability to resolve problems in everyday living.70 It assesses two constructive or adaptive problem-solving dimensions (positive problem orientation and rational problem-solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, and avoidance style). For this trial, an overall summary score was calculated, with scores ranging from 0 to 20 with lower values indicating poorer problem-solving ability. Psychometrically, the SPSI-R is characterized by strong reliability and validity. Internal consistency reliability is estimated at .95 and test–retest reliability ranges between .89 and .93. In addition, analyses of data from other studies have demonstrated that the SPSI-R has good structural, concurrent, predictive, convergent, and discriminant validity.69–72
The demographic and clinical characteristics of control and experimental groups were compared. Bivariate analyses of the effects of the intervention on the physical and psychosocial experiences of younger women with breast carcinoma at both 4 and 8 months postbaseline were conducted. Analysis of variance (ANOVA) was used to assess differences in means for continuous variables and the chi-square test for independence was used for categorical measures, specifically testing to reject the null hypothesis of no significant differences by randomization status.
Multivariate analyses were also conducted to test the effect of the intervention while controlling for other factors, using multiple ordinary least square regression for continuous outcomes and logistic regression for dichotomous outcomes. Baseline measures were included in each equation, predicting outcomes at both follow-up assessments to account for patients' status before implementation of the intervention. In addition, to control for stratification by PSP status, all models included two variables that indicated whether the patients had nominated their spouse/significant other (0 = no; 1 = yes) or another individual (0 = no; 1 = yes), with the reference category being no support person. Due to unavoidable delays in completing all six sessions for some patients receiving the intervention, women in the experimental group completed both of their follow-up assessments approximately 1 month later than those in the control arm. Therefore, the number of months from the start of chemotherapy treatment to follow-up data collection was also added to control for elapsed time and treatment phase.
We investigated the influence of patients' baseline problem-solving scores, as measured by the SPSI-R, on the effect of the intervention. We wanted to determine whether some subgroups of women may have been more likely to benefit from this particular type of intervention than others. Because the schedule of contacts, or exposure to the intervention, was less intensive than the program on which it was based,49, 50 we were uncertain of its effectiveness with all subgroups, especially women who had limited problem-solving skills before study entry.
To determine whether there were meaningful cutoff points in the continuum of SPSI-R scores, indicating a level of problem-solving ability necessary for intervention benefit, we examined the intervention effect as measured by the CARES global average severity scores at 8-month evaluation, stratified within subsets of patients categorized according to their SPSI-R scores at baseline assessment. We calculated the intervention effect for each subgroup by subtracting the mean score for experimental subjects from the mean score for control subjects. A positive value is indicative of an intervention benefit because higher CARES global scores signify poorer outcome. Because the number of experimental and control subjects within a discrete class of SPSI-R values (e.g., < 10.0, 10.0–10.9, 11.0–11.9, etc.) was quite small (fewer than 10 in most cases), we performed these calculations utilizing overlapping ranges of scores to include greater numbers of patients in each category. This is an ad hoc method of kernel smoothing that describes the covariate effect, in this case, the intervention effect, as a function of baseline SPSI-R scores (i.e., the functional form of the interaction between intervention and SPSI-R score).71 The primary advantage of this method over creating one interaction term is that the latter approach assumes the difference in effect to be a linear function of SPSI-R, whereas the former allows for the examination of nonlinear associations. Interaction terms consisting of intervention status and SPSI-R score ranges identified as transitions between intervention benefit and nonbenefit were then added to regression models for all outcome measures.
Of the 183 eligible subjects referred to the study, 164 agreed to participate in the research (response rate, 89.6%). Participants completed the baseline telephone interview 3.7 ± 2.3 weeks after receiving their first chemotherapy treatment. Following baseline assessment, 87 women were assigned randomly to the intervention and 77 were assigned to the control arm. The demographic and clinical characteristics of the experimental and control subjects at baseline were very similar, with no statistically significant differences (Table 1).
Table 1. Sample Description by Randomization Status
Control (n = 77)
Experimental (n = 87)
Total (n = 164)
Includes partial mastectomy, quadrectomy, subtotal mastectomy, wedge resection, total mastectomy, simple mastectomy, and modified radical mastectomy.
Despite efforts to recruit minority subjects from sites with a high representation of minority patients (NJ and PA), the majority of this sample was recruited in RI, where minority representation in the overall population is low. Feedback from staff at the NJ sites indicates that many minority women, particularly African American women, present at later stages of disease and thus were not eligible for this study. Therefore, most trial participants are white.
Approximately 78% of patients participated in the study with a PSP. About one half of these women nominated a spouse or significant other whereas the remainder nominated another relative or friend. Nearly two thirds of women are married and about three fourths have children.
This sample of women is fairly well educated, with about 40% having a bachelor's or a more advanced degree. Similarly, about 40% report household incomes over $60,000. Three fourths of the women report being employed, although about one half are not currently working, presumably because they are undergoing treatment for their disease.
The majority of women (61%) were diagnosed with Stage II disease. A nearly equivalent proportion of the sample (60%) had a mastectomy, whereas the remainder had breast-conserving surgery.
Fifteen patients (11 experimental and 4 control subjects) dropped out before study completion. An overview of subject participation is provided in Figure 1. Drop-outs were significantly less likely than completers to be white, non-Hispanic, to be employed, and to have annual household incomes over $60,000 (P < 0.05). Drop-outs also reported more physical and psychosocial problems at baseline than completers, as indicated by a higher CARES global score, higher IES avoidance scores, and lower MHI-5 weighted index scores (P < 0.05). On a scale of 1–10, with higher numbers indicating better coping, they also rated themselves lower in terms of dealing with their breast carcinoma diagnosis and its treatment (P < 0.01).
Effect of the Intervention on Patient Outcomes
Table 2 compares average group (experimental and control) scores on study outcomes at baseline and at first (4 months postbaseline) and second (8 months postbaseline) follow-up assessments. Although the direction of effects suggests that patients who received the home care training coped better than those randomized to the control arm at 4 and 8 months postbaseline, as indicated by the majority of outcome measures, none of these bivariate relationships are significant at the P < 0.05 level (Table 2).
Table 2. Bivariate Results: Physical and Psychosocial Adjustment by Randomization Status at Baseline, 4-Month, and 8-Month Assessments
Control (n = 77)
Experimental (n = 87)
Control (n = 75)
Experimental (n = 79)
Control (n = 73)
Experimental (n = 76)
CARES: Cancer Rehabilitation Evaluation System.
Higher scores indicate poorer status.
Any unmet need among patients with any need for assistance.
Results of regression analyses indicate that although the direction of the effect of experimental status on CARES global and most subscale scores is as hypothesized, none of these effects are statistically significant (data not shown). However, women selected to participate in the home care training program were significantly less likely to report unmet need for practical assistance at the 4-month assessment (P < 0.05). Similarly, there is a positive effect of the intervention on mood state, as measured by the MHI-5, at first follow-up (P < 0.05). However, these effects are no longer statistically significant at the second follow-up. There were no significant predicted associations with the intrusion and avoidance subscales of the IES at either time period.
Targeting Intervention Effectiveness by Problem-Solving Orientation
The results of analyses designed to target subgroups of women most likely to benefit from this intervention revealed a curvilinear relationship between baseline problem-solving score and intervention effectiveness as measured by the CARES. Women randomized to experimental status with SPSI-R scores of 12.5 and lower and with scores of 17.5 and higher fared worse than controls on the CARES global final (8-month) assessment (Fig. 2). Although we initially examined interactions of experimental status with both low and high SPSI-R scores in multivariate models, interactions using the upper cutoff point were not significant and were dropped from all models.
Results of regression models containing this interaction of experimental status and low baseline problem-solving ability are presented in Table 3. An interaction effect was apparent only for the model predicting the CARES physical subscale score at first follow-up measure, indicating that experimental subjects with SPSI-R scores greater than 12.5 were more successful in resolving symptoms than were women in the control arm of the study. At the second follow-up assessment, however, the intervention is associated with a significant decrease in the overall severity of problems experienced by women with SPSI-R scores greater than 12.5, as measured by the CARES global measure (P < 0.01), whereas experimental subjects with SPSI-R scores of 12.5 and lower fared worse than control subjects on this outcome (P < 0.01). The interaction between baseline problem-solving ability and experimental status is illustrated in Figure 3.
Table 3. Impact of the Intervention on Patient Outcomes as a Function of Baseline Problem-Solving Ability: CARES Global and Subscale Scores at 4-Month and 8-Month Assessmentsa
Global β (SE)
Physical β (SE)
Medical β (SE)
Psychosocial β (SE)
Marital β (SE)
Sexual β (SE)
CARES: Cancer Rehabilitation Evaluation System; PSP: primary support person; EXP: experimental; SO: Significant other; SPSI-R: Social Problem-Solving Inventory-Revised.
Findings regarding the CARES global measure are reflected in four of the five CARES subscales (physical, psychosocial, marital, and sexual). That is, among women with baseline SPSI-R scores above 12.5, experimental subjects were significantly more successful in resolving problems than controls. Among women with scores of 12.5 or lower, an inverse relationship between experimental status and problem resolution was observed.
The results of this randomized trial demonstrate the efficacy of a problem-solving therapy-based home care training intervention for younger women with breast carcinoma in improving mood and resolving unmet need for help with daily living tasks. Further, the intervention was effective for the majority of women in resolving a range of problems related to cancer and its treatment, including physical side effects, marital and sexual difficulties, and psychological problems. However, experimental subjects with poor problem-solving skills before the intervention were less likely than their control counterparts to resolve cancer-related problems. Finally, the intervention was not effective in reducing intrusive thoughts or avoidance behavior.
The seemingly nonintuitive finding that women most in need of improving problem-solving skills were actually negatively affected by a program designed to accomplish this outcome may be attributable to the “light” nature of the intervention (i.e., two in-person and four telephone contacts over a 4-month period). Feedback from the nurse interventionists in this study suggests that some women may have been overwhelmed by expectations to approach problems systematically following only one in-person contact. The intervention may have added to their distress, further impeding their efforts to resolve outstanding difficulties. This interpretation is supported by the fact that a higher proportion of experimental subjects than controls (12.6% vs. 5.2% dropped out of the study. Baseline IES avoidance and MHI-5 index scores indicated that drop-outs were significantly more distressed than completers, and may have perceived the intervention as an additional burden.
In fact, a more intensive version of this intervention, i.e., 10 one and one-half hour sessions provided individually, has been associated with substantial improvement among samples of people with clinical depression, a population also likely to exhibit poor problem-solving skills.40, 41 Moreover, results from a recent clinical trial of this same intensive problem-solving training protocol for men and women with a variety of cancer diagnoses who initiated therapy due to significant psychological distress indicate such training to be highly efficacious, regardless of baseline problem-solving ability.72
Targeting analyses also suggest that women who are very good problem solvers, like those with poor skills, may have been affected adversely by this intervention. However, this finding is inconclusive given the few women with excellent problem-solving skills who participated in this study. Further research is required to determine whether and why this subgroup of women did not realize a benefit. The reasons may be quite different from those for women with poor problem-solving ability.
The issue of appropriate targeting of an intervention to the population most likely to benefit is an important one. As we have seen in this trial, the outcomes of women with poor problem-solving ability, arguably the women most in need of improving their skills, were affected adversely relative to control women. An unanticipated adverse effect of an intervention to improve screening for cervical carcinoma among subgroups of the study population has also been reported.73
The danger of failing to target according to level of need or risk of the outcome in question is well known in the geriatric arena in regard to testing the efficacy of geriatric assessment in improving outcomes of frail elders74, 75 and to the possibility of avoiding nursing home placement through provision of home care services.76 In both cases, directing the intervention at too broad a population, including subgroups of people at low risk for study outcomes, diluted the ability of investigators to demonstrate efficacy, thus slowing progress in further development of programs that may have the potential to be highly efficacious when appropriately targeted.
The field of behavioral research in cancer prevention has benefited from use of the transtheoretical model of behavior change, which is used to vary intervention content and structure according to subjects' “readiness” to change behavior.77 When the intent of an intervention is not to change behavior but to address a need, a number of patient factors may be relevant. Level of need is an obvious consideration. In the case of the trial reported here, the content of the intervention may have been appropriate for the population of younger women with breast carcinoma in its entirety, but the structure of the intervention was inappropriate for women with high levels of need. Other factors that are more relevant to content than structure and that have differentiated subgroups who do and do not benefit from specific interventions include age78, 79 and personality characteristics.80, 81
Ethnicity may also be a key consideration in intervention targeting although there have been too few trials involving multiple ethnic groups with sufficient representation to be able to determine variation in intervention efficacy as a function of ethnicity. In fact, minorities are underrepresented in this trial, despite the inclusion of recruitment sites with primarily minority populations. Thus, the results reported here are generalizable to a white middle-class population only; future research is required to determine whether the content and structure of this intervention is responsive to the needs of ethnic minorities.
Although average to good problem solvers in the experimental arm of this study were more successful than their control counterparts in reducing problems and resolving issues in the majority of outcome areas, the intervention was not effective in resolving problems with their medical providers. Focus groups conducted in the development phase of this research revealed physician–patient communication surrounding treatment decision-making to be particularly problematic for younger women with breast carcinoma, exacerbating the stress inherent in the diagnosis and treatment of cancer.82 Unlike other study outcomes, women's problems with providers increased over the course of chemotherapy treatment, suggesting that resolution of difficulties in this area may require a concerted effort to educate physicians regarding this population's legitimate need for information regarding their disease and treatment, and their expectations for participation in decision-making.
The lack of an intervention effect on either of the IES subscales suggests that resolution of intrusive thinking and/or avoidant behavior may take longer than the resolution of other types of problems. Alternatively, alleviation of trauma may not be amenable to this “low exposure” approach in which the majority of contacts were made by telephone. Women who experience breast carcinoma as trauma may require the services of a mental health professional, such as that potentially afforded by a more intensive problem-solving treatment protocol, to alleviate psychiatric disturbance at this level.
There were virtually no differences in the effect of the intervention on women as a function of PSP status, including whether a PSP participated and, for women with a participating PSP, whether that person was a spouse or significant other versus another relative or friend. This is likely due to the fact that the intervention was directed primarily at younger women with breast carcinoma, with PSPs relegated to “helper” positions. In reality, the nurse interventionists reported that most PSPs were not active participants in the initial in-person session, but rather silent observers of interactions between the nurse and woman with breast carcinoma. PSPs were not involved in the four telephone contacts, and few were present at the final in-person session. The role of the PSP would have to be structured more definitively to influence the effectiveness of the intervention on women's outcomes.
Confirming the results of previous research, baseline scores on outcome measures indicate that younger women with breast carcinoma participating in this trial experienced more distress than samples of women with breast carcinoma of all ages.52, 57, 62 Also, women in this sample were more distressed than a sample of women seeking care for other medical conditions, but less distressed than women seeking care from mental health providers.61, 64 Although the severity of problems generally decreased over time, the effect was not linear for all outcome measures. Scores worsened on the CARES subscale measuring interaction with medical providers from baseline to the first follow-up assessment. Although some outcomes improved from first to second follow-up (e.g., the CARES physical subscale), other outcomes (e.g., the CARES psychological subscale and the MHI-5) improved from baseline to first follow-up and then stayed approximately the same for the remainder of the study period. Although physical side effects may gradually but steadily subside, psychological difficulties may prove more difficult to resolve.
This pattern of distress among younger women with breast carcinoma argues for an intervention that supports and encourages women throughout the diagnostic and treatment phase. For the majority of women participating in this trial (approximately two thirds of the sample), the intervention likely provided a focus for marshalling and improving problem-solving abilities acquired before the cancer experience, applying them in a systematic and effective manner to the information provided in the intervention manual. The intervention may have empowered women to bring order out of the emotional chaos often associated with cancer and its treatment, allowing them to cope effectively with the many issues that arise. It is encouraging that the effect of the intervention was strongest at the 8-month rather than at 4-month assessment. Although women may continue to grapple with cancer-related psychosocial issues, these findings suggest that problem-solving techniques may improve over time and that women become accustomed to coping with their problems in this positive, effective manner.
A shortcoming of this intervention as implemented for this trial was its initiation at the beginning of chemotherapy, rather than immediately following diagnosis. In fact, when asked how the intervention might be improved, women's overwhelming response was to introduce the intervention during the diagnostic phase, when need for information regarding disease and treatment options is high.
In conclusion, the results of this randomized trial show that this problem-solving therapy-based home care training intervention for younger women with breast carcinoma is a practical, cost-effective method of helping the majority of such women to reduce the stresses and solve the problems associated with the diagnosis and treatment of cancer in mid-life, the busiest stage of the life course. High rates of study participation and completion suggest a high level of desire in this population for a formal program to support women through the diagnostic and treatment phase of the disease.
The authors thank Peter S. Houts, Ph.D., for his invaluable role in adapting the Home Care Guide for Cancer for use in this article.