Randomized Trial of Therapeutic Group by Teleconference

Randomized Trial of Therapeutic Group byTeleconferenceAfrican American Women With Breast Cancer

Sue P. Heiney, PhD, RN1; Sandra Millon Underwood, PhD, RN2; Abbas Tavakoli, DrPh2; Swann Arp Adams, PhD1;

Linda M.Wells, MA, RN, PhR1; and Lisa H. Bryant, MD1

BACKGROUND: The effects of a therapeutic group by teleconference for African American women with breast cancer

have not been documented, although the benefits of therapeutic groups for European women are well established.

African American women with breast cancer may experience social disconnection, a sense of being cut off from part-

ners, family, and friends because of side effects of treatment and fatalistic beliefs about cancer. A therapeutic group

by teleconference may counteract these problems and improve social connection. METHODS: A randomized trial

design stratified by treatment type was used. Data were collected at baseline, at the end of the intervention, and 16

weeks from baseline. Repeated-measures, fixed-factor analyses of covariance were used for each outcome. The

between-subject factors were group and replicate set, and the within-subject factor was time. Physical well being

and educational level differed significantly between the 2 groups at baseline and were used as covariates. RESULTS:

The mixed-model analysis of the outcome variables revealed significant changes over time for knowledge (P � .001),

with higher scores on knowledge observed for the control group. Group-by-time interactions were observed for fatal-

ism (P ¼ .0276), fear (P ¼ .0163), and social connection (P ¼ .0174) as measured by the Social Well Being subscale

from the Functional Assessment of Cancer Treatment-Breast Cancer Version. No group-by-time interaction was

observed for social connection as measured by the Social Support Questionnaire. Social connection measured with

the Social Well Being subscale improved significantly in the intervention group, whereas fatalism and fear significantly

decreased. CONCLUSIONS: In this study, the authors documented the benefits of a therapeutic group by teleconfer-

ence, a novel way to provide support for African American women with breast cancer. Further research should

include a behavioral outcome, such as treatment adherence. Cancer 2011;000:000–000. VC 2011 American Cancer

Society.

KEYWORDS: breast cancer, African American, intervention study, social connection, fatalism.

INTRODUCTIONHealth disparities in African American (AA) women with breast cancer are well documented, including a black/whitemortality differential.1 Factors like age and stage of diagnosis, differential/unequal treatment, and tumor biology partiallyexplain the mortality difference.2-4 Another factor, social disconnection (a sense of being cut off from important relation-ships) has not been studied well but also may decrease survival.5 Conversely, the benefit of social connection in improvinghealth, especially in AAs, is well documented.5-8 Social connection may influence behavior through role modeling, provi-sion of information, practical support to participate in health activities, and emotional support to overcome fear of proce-dures or results of tests and treatments. Also, social connection improves quality of life and enhances recovery.9-11

DOI: 10.1002/cncr.26676, Received: August 10, 2011; Revised: October 11, 2011; Accepted: October 13, 2011, Published online Month 00, 2011 in Wiley Online

Library (wileyonlinelibrary.com)

Corresponding author: Sue P. Heiney, PhD, RN, FAAN, 1601 Greene Street, College of Nursing, Columbia, SC 29208; Fax: (803) 777-7429; [email protected]

1College of Nursing, University of South Carolina, Columbia, South Carolina; 2School of Nursing, University of Wisconsin Milwaukee, School of Nursing, Milwaukee,

Wisconsin

At the time a portion of this research was conducted, Sue P. Heiney was employed as Manager of Psychosocial Oncology at Palmetto Health Cancer Centers in

Columbia, SC.

We thank Linda Hazlett, PhD for data management and Rudy Parrish for the original power analysis.

The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the

National Institutes of Health.

Cancer Month 00, 2011 1

Original Article

After a cancer diagnosis, AA women may experience

social disconnection because of cancer stigma, fatalism,

treatment-related side effects (especially hair loss and

fatigue), cultural role expectations, socioeconomic disad-

vantages, and family burdens.12-20 Thus, at a time of

increased stress, AA women with breast cancer may be iso-

lated from usual informational and emotional support,

resulting in decreased social connection. Surprisingly,

only a few interventions have been developed specifically

for AA women after a breast cancer diagnosis, and

none address social connection.21,22 Given the health

and quality-of-life benefits of social connection, it is crit-

ically important to develop and test interventions to

improve social connection among AA women with breast

cancer.23

Over the past 3 decades, more than 25 studies have

established that therapeutic groups for women with breast

cancer improve social connection.24-26 Unfortunately, the

participation of AA women with breast cancer in these

studies was <10%.27,28 Only 1 study was identified that

tested a therapeutic group for AA women with breast

cancer,21 and no researcher tested a therapeutic group by

teleconference. Although little research has been con-

ducted on therapeutic groups by teleconference, research-

ers have demonstrated that this delivery modality

improves mood and social support for physically disabled

elderly,29 visually impaired elderly,30 and women with

breast cancer.31 The value of the teleconference modality

reported in those studies suggests the need for further

research, especially among AA women with breast cancer.

These women face many barriers to participation in face-

to-face groups, including travel and family responsibil-

ities. The current study builds on our pilot work and tests

a therapeutic group by teleconference for AA women with

breast cancer. To our knowledge, our study is the largest

psychosocial intervention study to date of AA women

with breast cancer.

MATERIALS AND METHODS

Objective

The objective of this study was to test the hypothesis thata therapeutic group delivered by teleconference wouldincrease social connection compared with a control groupreceiving usual care. Our secondary aims were to decreasefear, isolation, and fatalism and to increase cancerknowledge.

Intervention Description

The research tested an intervention based on our pilot,32

which included Yalom’s Group Intervention Theory,33

the story work described by Heiney et al, and the thera-peutic group work described by Fawzy and Fawzy.31,34

We previously described the intervention and its evalua-tion, and a brief summary is provided below.35 We gavethe study an acronym name, STORY (Sisters Tell Othersand Revive Yourself) to aid in recruitment and studyrecognition and to define our study purpose. Our inter-vention was designed to serve as a temporary social con-nection, providing support and information whenrelationships within a woman’s social network may bestrained. Traditionally, in the AA culture, women rely onfamily and community as a source of strength, coping,and stability. However, a diagnosis of cancer may disruptsocial connection because of cancer stigma, fatalisticbeliefs about cancer, role expectations, and the side effectsof treatment. Because of these negative influences onsocial connection, AA women with newly diagnosedbreast cancer need an alternative social connection thatcan promote coping with the disease and reconnecting tofamily and community. The intent of the intervention isto improve social connection through story sharing,examination of hypothetical coping stories, and by pro-viding information about a variety of topics to help copewith disconnection.

The therapeutic group intervention was led by 2social workers who had experience working with oncologypatients and leading support groups. They also receivedtraining based on the STORY group leadership manual.

The intervention was delivered by teleconferencewith participants interacting in real time with each other.The sessions lasted 90 minutes and were held weekly for 8weeks; then, booster sessions were held every other weekfor 2 weeks. Session 1 focused on orienting group mem-bers about how the conference call would work, getting toknow one another, and a brief overview of methods ofcoping. Sessions 2 through 8 had individual topics, andthe order of those topics was determined by focus groupsof AA patients and professionals.35 The topics for eachsession originated from the work of Fawzy and Fawzy andincluded the following: Session 2, feelings, fears, myths;Session 3, stress management and communication;Session 4, family relationships; Session 5, treatment; Ses-sion 6, intimacy and self-image; Session 7, recurrence;and Session 8, social network. Sessions 9 and 10 werebooster sessions, and no new content was discussed. Intotal, 10 sessions were conducted. The sessions followed a

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2 Cancer Month 00, 2011

script with 3 parts: personal story sharing by the partici-pants, content provided by the group leaders, and exami-nation of hypothetical coping stories. Throughout allsessions, the group leaders encouraged sharing of feelings,identification of common experiences, and connectingwith group members.35 We previously reported on inter-vention integrity35; thus, as a check that each replicate setwas exposed to similar leadership, we had 2 experiencedgroup leaders to review the audiotape of each session. Thegroup reviewers used a check sheet to verify that thecontent was followed and that appropriate leadershipstrategies were used to build commonality, connection,catharsis, and story—our intervention’s active ingredients.If the leaders identified that the leadership script was notadequately followed, then the project coordinator metwith the group leaders and pointed out discrepancies.

Usual Psychosocial Care (Descriptionof Control)

Usual psychosocial care was defined as any support used bythe patient in the course of cancer treatment. For individu-als in the control group, no attempts were made to limitaccess to or use of psychosocial care available to breastcancer patients in the community or to national educationalor supportive resources. Because both control and interven-tion participants may have attended support groups orreceived other psychosocial support, we carefully monitoredall participant’s use of psychosocial resources. At eachassessment, participants completed the PsychosocialSupport Use Scale (PSUS), which was adapted from thepilot based on Merle Mishel’s Type of Information/SupportChecklist (University of North Carolina Chapel Hill) andwas used with permission. The PSUS contains 13 items toinventory psychosocial support services and programs usedby the patient before and during the intervention period.The participants indicated which services or programs wereused, and these were summed for a total score. There wereno differences in support use at any time point when thecontrol and intervention groups were compared. In addi-tion, 35% of control participants (n¼ 93) reported attend-ing a breast cancer support group between the baselineassessment and assessment 2 (which occurred after theintervention was completed). Overall, there were no differ-ences in support use at any time point when the control andintervention groups were compared.

Study Population

Patients were included in the study if they were US-born,English-speaking AA women aged �21 years who had

been diagnosed with invasive ductal breast cancer withinthe past 6 months and who underwent lumpectomy.Study participants were restricted to those who underwentlumpectomy for study design and therapeutic reasons. Wewanted to increase the internal validity of the study bydecreasing variability because of different surgical treat-ment and its impact on the participants’ physical status.Also, we wanted to minimize variability in the interven-tion sessions, because women who undergo lumpectomyhave vastly different recovery experiences than those whoundergo mastectomy (women who undergo mastectomymay have more pain and surgical side effects). These dif-ferences would have impacted the group climate andcontent of the sessions. Patients were excluded from thestudy if they had metastatic disease at diagnosis, a currentdiagnosis of psychosis or a major cognitive impairment,or a past or current diagnosis of cancer (except basal cell orsquamous cell of skin), or if they were participating inanother behavioral clinical trial. Participation in a medicaltreatment trial was not an exclusion factor.

Design

We used a multiple-group, nonblinded, intention-to-treat, randomized trial design to compare the therapeuticgroup intervention with a control group receiving usualpsychosocial care. A maximum of 10 participants wereassigned randomly to each of 2 groups during a commontime period, with 1 group receiving the interventionand the other receiving usual care. In 15 replicate sets, weenrolled 185 patients between September 13, 2006 andApril 7, 2010. Because the study was conducted in repli-cate sets, final data collection for each set of participantsoccurred 16 weeks after the first assessment (baseline).The last replicate set began on April 26, 2010 and endedon July 12, 2010.

Setting and Procedures

The study was conducted in 1 Southern state with recruit-ment emanating from a central recruitment office of theprincipal investigator. Our study was approved by thePalmetto Health Institutional Review Board (IRB) andby the IRB of each site that generated participants. Wepreviously reported on our recruitment framework andprocedures.36

Potential participants were identified from self-referral or from physician referral using a signed release ofprotected health information or partial waiver of pro-tected health information from the IRB. Screening foreligibility included the date of confirmed pathologic

Randomized Trial Therapeutic Group/Heiney et al


diagnosis (either through the cancer registry or from theparticipants’ medical records using a signed release of pro-tected health information). This date was used to confirmthe eligibility criteria of 6 months from diagnosis to studyentry, which we defined as verbal consent to participate inthe study. After potential participants exceeded the 6-month date, we discontinued efforts to enroll them in thestudy.

After patients were screened and their eligibility wasverified, informed consent was obtained at a location ofthe participant’s choice, usually her home. Because of thepotential for low literacy, all consents were read to partici-pants. Participants received a $20 gift card at each assess-ment as well as a small gift valued at about $3. The giftwas in keeping with Southern culture when visiting in thehome. Regardless of group assignment, participantsreceived a small gift valued at $1 to $3 by mail over the 16weeks of the intervention (gifts matched the interventiontimes: weekly for 8 weeks and every other week for 2weeks).

Participants were evaluated at 3 time points 1) atbaseline before the intervention began, 2) at the end ofthe intervention period, and 3) 16 weeks from baseline.Participants provided information on their health andmedical history at baseline. We did not conduct a medicalchart audit to ascertain medical history or data suchas stage at diagnosis. Our inclusion/exclusion criteriarequired verification of certain medical informationbefore enrollment. Outcome variable data were collectedat all 3 time points.

Randomization

After patients were screened for eligibility, consented,and completed the first assessment, they were assignedrandomly to either the intervention group or the controlgroup. The randomization was stratified by treatmenttype (chemotherapy only, radiation therapy only, orchemotherapy and radiation therapy combined). Ran-domization was completed by the statistician using a com-puter program. The enrollment, assessment, or treatmentteam members and the principal investigator were notinvolved in the randomization. Once randomization wascompleted, the assignment was sent to the project coordi-nator, who notified patients by mail and/or telephone oftheir assignment. See Figure 1 for the flow diagram of thestudy population. It is noteworthy that, using our recruit-ment model, we recruited 68% of the eligible women,36

which was a much higher proportion than that reportedin most behavioral clinical trials.27,28

Outcome Measures

We established 5 outcomes for our study: increased socialconnection, increased knowledge, decreased fear, de-creased isolation, and decreased fatalism. The instrumentswere chosen for their use in cancer patients and if possiblein AA samples.

Social connection

Social connection was assessed with 2 measures: theNorthouse Social Support Questionnaire (SSQ) and theSocial Well Being subscale (SWB) from the FunctionalAssessment of Cancer Therapy-Breast Cancer Version(FACT-B) (version 3). Because of difficulty in locatingculturally appropriate measures of social connection, weused 2 measures to operationally define this outcome.

Northouse Social Support Questionnaire

The Northouse SSQ is 24-item scale that measuresthe amount of perceived emotional connection with part-ners, family, and nonkin. Moderate construct validity wasestablished when the SSQ was compared with the FamilyEnvironment Scale. Original testing indicate that internalconsistency was 0.90,37 and subsequent testing indicatedinternal consistency of 0.9038and 0.87.39,40 The scale wasused previously in a study that included AA women withbreast cancer.41 The Cronbach alpha for the current sam-ple was 0.90.

Social Well Being subscale from the FunctionalAssessment of Cancer Therapy-Breast Cancer Version

We used the 7-item SWB subscale from the FACT-B as a second measure of social connection. This subscalewas designed as a measure of social well being in patientsto assess outcomes in clinical trials, but we used it as aproxy to measure social connection. The authors acknowl-edged the limitations of this proxy; however, at the timemeasurement decisions were made, this measure had beenused in an AA sample,41 had demonstrated strong reliabil-ity and validity, and the items assessed information aboutrelationships.42 Furthermore, the subscale could be inter-preted independently. Lower scores on the SWB indicatepoorer functioning. The reliability coefficient for the totalscale has been reported as 0.90.42 The Cronbach alpha forthe current sample was 0.797.

Cancer knowledge questionnaire

Breast cancer knowledge was measured with the 17-item Breast Cancer Knowledge Scale. This scale usesresponses of ‘‘true,’’ ‘‘false,’’ and ‘‘don’t know’’ to deter-mine the amount of correct information the participant

Original Article


has about breast cancer symptoms and treatment sideeffects.43 A response of ‘‘don’t know’’ is considered awrong answer. The score is the percentage of correctanswers and ranges from 0% to 100%. The Cronbachalpha was 0.77 from a sample of 163 women under theage of 65 years (C. J. Braden, personal communication).For the current sample, the Cronbach alpha was 0.61.

Tension-Anxiety subscale from the Profileof Mood States-Short Form

Fear was measured with 5 items comprising theTension-Anxiety (TA) subscale of the Profile of MoodStates-Brief (POMS-B).44 We used the TA subscale inour pilot, and it has been used extensively in cancerpatients.45 Responses range from ‘‘not at all’’ to‘‘extremely.’’ The responses range from 0 to 4, with higherscores indicating greater tension and anxiety. Cronbachalpha for the TA subscale was 0.90. Test-retest reliabilityof the subscale ranged from 0.65 to 0.74. Reliability for

the overall short form in our pilot study with a 27% AAsample was 0.88.34 Repeated testing using factor analysisdemonstrated validity.46 The Cronbach alpha for thecurrent sample was 0.77.

University of California-Los AngelesLoneliness Scale, version 3

The 20-item University of California-Los AngelesLoneliness Scale measures perceptions of isolation fromrespondents with such items as, ‘‘I feel isolated fromothers.’’47-49 Responses range from 1 to 4, possible scoresrange from 20 to 80, and higher scores indicate greaterloneliness and isolation. Extensive validity testing hasreported strong validity.48 The reliability reportedlyranges from 0.89 to 0.94 across samples. The scale hasbeen used in a sample that included AA women withbreast cancer in which the Cronbach alpha was 0.93.50

For the current sample, the Cronbach alpha was 0.84.

Figure 1. This illustration of the study flow depicts screening, recruitment, allocation to study condition, and follow-up.



The Revised Powe Fatalism Inventory

Fatalism was measured using an 11-item scalerevised by Mayo for a breast cancer sample51: the PoweFatalism Inventory Revised. The original tool measuresthe defining characteristics of fatalism, God’s will, andeventual death.52-58 Powe established validity and reliabil-ity at 0.84 to 0.87. Other researchers reported reliabilityas high as 0.89. Scores range from 0 to 11. Mayo et alreported that a score >5 was indicative of high fatalismand Gullate (2009)59 concurred. The Cronbach alpha forthe current sample was 0.64.

Analysis Plan

The study objectives were to determine whether a thera-peutic group by teleconference would increase social con-nection compared with a control group receiving usualcare. We used an intention-to-treat analysis plan in whichwe retained all participant data for the final analysisregardless of trial participation. Our secondary objectiveswere to decrease fear, isolation, and fatalism and toincrease cancer knowledge. Descriptive statistics wereobtained for demographic and health data.

Our original power analysis was conducted usingpublished data from the FACT total score.60 This analysisdetermined that a sample of 216 was estimated to yield90% power for outcome measures at each time point usinga 1-sided hypothesis test with .05 level of significance set asthe level of significance. Preliminary data were not availablefor social connection as measured by the SSQ.We enrolled185 participants by the end of the trial. Because we had aslightly smaller sample than planned, we conducted a posthoc power analysis of our primary outcome as measured bythe SWB subscale from the FACT-B, including the covari-ates and the fixed effect of wave. By using results from ProcMix in the SAS statistical software package (version 9.2;SAS Institute, Inc., Cary, NC), we calculated that we had72%power to detect between-within interaction effects.

RESULTS

Study Population

We enrolled 185 AA women from 26 of the 46 countiesin the state. Our participants ranged in age from 24 yearsto 83 years (mean� standard deviation [SD], 56� 11.06years) and reported that they had from zero to 8 comorbidconditions (mean � SD, 2.07 � 1.57 comorbid condi-tions). For complete details of our study population, seeTable 1. We attained overall high retention (93%; n ¼185). Retention was slighter higher in the control group

at 96% (n ¼ 93) than in the intervention group at 91%(n¼ 92).

To examine our randomization, we tested for base-line differences between the control group and the inter-vention group. At baseline, there were no significantdifferences between the control and intervention groupson age, partner status, income, comorbid conditions, timefrom diagnosis, rural versus urban location, attendance atchurch and related activities, or the number of cancerresources used. There was a significant difference by edu-cation (P ¼ .0479), because the usual care group hadmore education. Also, there was a significant differencebetween groups on physical functioning (P ¼ .0399),because the intervention group had worse physical func-tioning. No significant baseline differences were observedbetween the control and intervention groups for any ofthe outcome variables (social connection, fear, isolationfatalism, and knowledge).

Intervention Integrity

We previously reported on 1 aspect of intervention integ-rity: participants’ highly positive perceptions of group

Table 1. Study Population Baseline Demographic and HealthCharacteristicsa

No. of Patients (%)

Characteristic ControlGroup,n 5 93

InterventionGroup,n 5 92

Marital statusMarried 37 (39.78) 33 (35.87)

Partnered 39 (41.94) 38 (41.30)

Not partnered 17 (18.28) 21 (22.83)

Incomeb

<$19,999 25 (30.86) 31 (40.26)

$20,000-$49,999 39 (48.15) 37 (48.05)

>$50,000 17 (20.99) 9 (11.69)

Education<High school 16 (17.20) 14 (15.22)

High school 21 (22.58) 36 (39.13)

>High school 56 (60.22) 42 (45.65)

Geographic areaUrban 41 (44.09) 28 (30.43)

Rural 52 (55.91) 64 (69.57)

TreatmentRadiation therapy 31 (33.33) 34 (36.96)

Chemotherapy 27 (29.03) 22 (23.91)

Radiation and chemotherapy

combined

35 (37.63) 36 (39.13)

a Some categories are greater than 100% because of rounding.b Twenty-seven participants chose not to answer; percentages are based

on those who did answer.

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value.35 In addition, we examined 2 other components ofintegrity, dosage and purity, to evaluate our intervention.Participant attendance (n ¼ 92) at all 10 group sessionsranged from zero to 10, and the mean � SD attendancewas 6.98 � 2.68 sessions (median, 8 sessions). This levelof attendance indicates that the majority of participantsreceived an adequate dose of the intervention, and only 2participants received no intervention. We had 2 inde-pendent group reviewers to assess the purity of the inter-vention delivery. Our 21-item purity form, which wasadapted from our pilot, evaluated (for each session) adher-ence to the structural and content components in themanual, leadership strategies, story, and therapeutic fac-tors. The scale contains yes/no responses that evaluatewhether or not the leader followed the script. Also, Likert-type items evaluate leaders’ attention to group process.After the sessions, the group reviewers met to identifyconcerns over group leadership. The project coordinatordiscussed these with the group leaders if needed. Finally,we conducted a validity check on changes in the outcomesthat could be attributed to the use of coping resources andsupport interventions strategies outside our intervention.At each assessment, participants completed the PSUS,which contains 13 items that inventory psychosocial

support services and programs used by the patient duringthe intervention period. The participants indicated whichservices or programs were used, and these were summedfor a total score. There were no differences in support useat any time point at which the control and interventiongroups were compared.

Outcomes

The means of the outcome variables at all time points areprovided in Table 2. T tests and chi-square analyses deter-mined that, at baseline, the control and interventiongroups differed only in terms of education and physicalwell being. These 2 variables were used as covariates in therepeated-measures, fixed-factor analyses of covariance foreach for each outcome variable. We used ProcMix in SAS9.2 for the analysis described below. The advantage ofthe use of ProcMix is that it takes into account the valueat each measure at each time point. In this model, thebetween-subject factors were group (intervention orcontrol) and replicate set (from 1 to 15), and the within-subject factor was time (baseline, assessment 2, and assess-ment 3). All statistical tests were evaluated at an alpha of.05. Table 3 provides results from the repeated-measures,fixed-factor analysis of each outcome with education and

Table 3. Repeated Measures Analysis Using ProcMix (Group, Time, and Group-by-Time Interaction) for Each Outcome VariableWith Physical Well Being and Education as Covariates (n¼185)

Outcome P for Wave P for Group P for Time P for Group-by-Time

Social connection (SSQ) .0136 .4468 .9815 .0776

Social connection (FACT-B SWB) .3569 .6244 .5205 .0174

Fear .6817 .8899 .2009 .0163

Isolation .4604 .6771 .8726 .2417

Fatalism .0958 .3128 .5133 .0276

Knowledge .0117 .9483 <.0001 .7903

Abbreviations: FACT-B SWB, Functional Assessment of Cancer Treatment-Breast Cancer Social Well Being scale; SSQ, the Northouse Social Support

Questionnaire.

Table 2. Means and Standard Deviations for Outcomes of Assessments at Time 1, Time 2, and Time 3a

Mean6SD Score

Intervention Group Control Group

Measure Time 1 (n 5 92) Time 2 (n 5 82) Time 3 (n 5 83) Time 1 (n 5 93) Time 2 (n 5 86) Time 3 (n 5 89)

Social connection (SWB) 23.52�5.15 23.79�4.93 24.94�3.26 23.80�4.58 23.50�4.90 23.43�4.60

Social connection (SSQ) 100.10�14.41 102.70�12.48 102.64�11.75 101.43�12.75 99.59�13.04 99.74�14.37

Fear 3.13�3.55 2.13�2.40 2.09�2.65 2.77�2.70 2.50�2.97 2.83�3.30

Isolation 28.85�8.55 28.01�8.57 27.78�6.15 27.89�7.64 28.38�8.62 28.27�7.53

Fatalism 3.49�2.09 3.52�1.96 3.12�1.90 3.46� 2.05 3.42�2.05 3.66�1.90

Knowledge 68.29�14.87 72.67�15.06 74.63�15.20 69.13�13.17 73.05�12.87 76.01�12.49

Abbreviations: FACT-B SWB, Functional Assessment of Cancer Treatment-Breast Cancer Social Well Being scale; SD, standard deviation; SSQ, the Northouse

Social Support Questionnaire.a The Time 1 assessment was at baseline before the intervention began, the Time 2 assessment was at the end of the intervention period, and the Time 3

assessment occurred 16 weeks from baseline.



physical well being as covariates. The mixed-model analy-sis of the outcome variables revealed significant changesover time for knowledge (P ¼ .001). Surprisingly, boththe control group and the intervention group had signifi-cant increases in cancer knowledge over time (P¼ .0001),but the control group had higher scores on knowledge.Table 2 indicates that the control group had higherknowledge at baseline than the intervention group,and the mean scores of the control group continued toincrease at assessments 2 and 3 and remained higherthan the intervention group scores. Group-by-time inter-actions were observed for fatalism (P ¼ .0276), fear (P ¼.0163), and social connection (P ¼ .0174) measuredby the FACT-B SWB subscale. No group-by-time inter-action was observed for social connection measured bythe SSQ (P ¼ .0076). Social connection measuredwith the SWB subscale improved significantly in theintervention group, and fatalism and fear significantlydecreased.

DISCUSSIONTo our knowledge, this is the largest controlled behavioraltrial of AA women with breast cancer that has tested anintervention to improve social connection.61 Also, only 1other study on therapeutic groups was identified thatfocused on a sample of AA women with breast cancer.21

Our study had twice the number of participants andoffered a much more accessible intervention (teleconfer-ence). Our findings support our hypotheses that a thera-peutic group by telephone would significantly increasesocial connection and decrease fear and fatalism comparedwith a control group. Our intent was for the interventionto provide a temporary support network for AA womenwith breast cancer when relationships with their naturalnetwork might be strained. We envisioned that, byaddressing fear, fatalism, and silence, a triad of barriersrelated to breast cancer in AA women, the participantswould gain confidence and coping skills. We anticipatedthat these skills could be generalized to the women’s natu-ral environment, as suggested by Yalom,33 and wouldimprove the women’s relationships with members of theirsocial network. Our data support the effectiveness of atherapeutic group in improving social connection. Thus,we expected that the intervention group would improveand that the control group might decompensate, becausecontrol group participants would be exposed to thesenegative influences without the buffering support fromthe STORY intervention.

Our methodology of using mixed models is astrength of this study, because as it incorporates baselinedifferences between groups. Previous interventions todecrease fatalism have focused on education about cancerand demonstrated that cancer education decreased fatal-ism.57 Our results are somewhat paradoxical; the inter-vention group had only small gains in cancer knowledge(less than the control group). We note that our examina-tion of the use of support resources, such as nurse naviga-tor or educational materials, did not reveal any differencesbetween the control group and the intervention group.The higher gains in the control group could be attributedto their having higher levels of education than the inter-vention group. Also puzzling is that previous researchreported an association between increased fatalism andhigher education and income levels in a sample of com-munity participants who were participating in a coloncancer screening program.55 In our sample, the controlgroup had higher education; but their fatalism scorescontinued to increase over time. Our findings suggest thata support group may change fatalistic beliefs about cancerthrough a different mechanism than education. Possibly,the decreased fatalism may be attributed to interactionwith other women who had a similar diagnosis and wereprogressing through treatment. Further research is neededto understand the role that social connection plays infatalistic beliefs about cancer. Our intervention alsodecreased fear in the intervention group.

This study has multiple strengths. First, we paidclose attention to cultural appropriateness in all phases ofour study, from design to implementation, involving acommunity advisory group of AA cancer survivors andprofessionals. We included their feedback in the proce-dures for recruitment, consent, data collection, and theSTORY intervention. Furthermore, because of commu-nity and professional involvement in the trial, our samplerepresented a group with lower socioeconomic status thanmany previous studies and included both rural and urbanparticipants. The participants in our trial represent indi-viduals with high health disparities who have receivedonly minimal attention in other psychosocial studies.Because of our stringent inclusion criteria, our sample washomogeneous. Also, by determining potential covariates,we controlled for their influence on outcomes.

The current study also has several limitations. Theresults may be generalized only to AA women whoundergo lumpectomy. The study had a lower level ofpower than desired. Although significant, the effect sizefor the social connection measure (FACT-G SWB

Original Article


subscale) was small. However, data regarding the FACT-G as a measure of trial effectiveness notes that, for thisoverall scale, 5 to 6 change points would indicate a mini-mally important difference and, thus, is clinically impor-tant.62 Change points for the subscales of the FACT-Bwere not examined62 for comparison with our results. Wedetermined that the difference in mean score on theFACT-G SWB in the intervention group from baseline tothe endpoint was 1.4. By using the distribution-basedanalyses described by Eton and colleagues, we observedthat the 1.4 change likely represents a minimally impor-tant difference and is clinically significant. Our recruit-ment and retention were quite high but did not meet ouroriginal recruitment goal. A larger sample size may haveyield higher power and more significant differences. Fur-ther research through cooperative trials is needed to betterexplore the benefits of the intervention.

Instrumentation was also a limitation. We had diffi-culty in locating culturally sensitive and low-literacyinstruments with which to measure our concepts. Further-more, we had difficulty finding instruments that matchedthe operational definition of our concepts and that hadbeen used with AA samples. Thus, we had slightly lowerthan desirable reliability measures on our instrumentsand, in some cases, had to eliminate instruments from anyanalysis because of very low reliability. In addition, manycancer education scales measure knowledge about breastcancer prevention rather than treatment and side effects.The items on the Cancer Knowledge Questionnaire63

tested general knowledge about breast cancer and may nothave adequately discriminated for the information pre-sented in our sessions. Another example of measurementlimitation is the use of the SSQ. The repeated-measuresanalysis of changes in SSQ scores over time between thecontrol and intervention groups was not significant (P ¼.0076), and the narrow range in means and the large SDsmay explain in part this lack of significance. At the timewe designed the study, the SSQ seemed to fit conceptuallywith our outcome (social connection) and was chosenalthough it had not been used in clinical trials. Futureresearchers may be able to use our data for power calcula-tions to help determine the clinical importance of results.

Our intervention has overall health implications,because it is known that social connection increases healthpractices. Thus, our intervention has the potential to con-tinue to benefit women long past their participation. Ourstudy could be improved by measuring health behaviorslike adherence to treatment in addition to psychosocialmeasures. Further research is needed in this population to

establish better instrumentation and to extend ourresearch findings.

FUNDING SOURCESThis project was supported by award R01CA107305 from theNational Cancer Institute.

CONFLICT OF INTEREST DISCLOSURESThe authors made no disclosures.

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Randomized Trial of Therapeutic Group by Teleconference

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