By Priscilla Abercrombie, RN, NP, PhD, AHN-BC

Women’s Health and Healing, Healdsburg, CA

Dr. Abercrombie reports no financial relationships relevant to this field of study.

SYNOPSIS: This randomized study demonstrated that an imagery program delivered either live or via telemedicine could improve quality of life in breast cancer survivors compared to a wait list group.

SOURCE: Freeman LW, et al. A randomized trial comparing live and telemedicine deliveries of an imagery-based behavioral intervention for breast cancer survivors: Reducing symptoms and barriers to care. Psychooncology 2015;24:910-918.

SUMMARY POINTS

  • The live and telemedicine delivery groups were equally effective in improving quality of life.
  • Only some parameters of quality of life were improved compared to the wait list group: fatigue, cognitive function, and sleep.

The purpose of this randomized, controlled trial was to evaluate whether an imagery-based group intervention delivered either by live delivery (LD) or by telemedicine delivery (TD) improved quality of life (QOL) among breast cancer survivors compared to a waitlist (WL) group. Participants were recruited via ads, media, and medical referrals. There were two LDs, one in Alaska and one in Washington, in which the facilitator was present at the community health center. One facilitator was a licensed professional counselor and the other a family practice physician. The TD group was held at a community health center in Alaska where the facilitator was remote. The videoconferencing software allowed the facilitator to control the camera direction and interact with small groups or individuals.

One of the facilitators developed the curriculum, which was titled “Envision the Rhythms of Life” and consisted of didactic and interactive activities. The authors provided the following example: Participants identified maladaptive “passive imagery,” created adaptive “active imagery” with the help and feedback of the group and facilitator, and practiced “targeted imagery” (i.e., imagining healthy immune function). In the last session, participants discussed their long-term plan for using the information from the program.

Participants were randomized into the three groups via adaptive randomization so the groups were balanced by age, gender, stage, chemotherapy, surgery, radiation, and hormone use. The LD and TD groups participated in five 4-hour weekly sessions with approximately 25 people per group. Each member of the group also had a < 10-minute weekly phone call to encourage home practice throughout the program and 3 months after completion. Eligibility criteria included diagnosis of breast cancer; 18 years of age; no major psychiatric illness (not defined); visual and hearing capable; able to read, write, and speak English; and oriented to person, place, and time. Of the 121 participants consented, 118 were randomized (LD = 48, TD = 23, WL = 47), 104 completed the intervention (LD = 41, TD = 19, WL = 44), and 102 completed the 3-month follow-up (LD = 40, TD = 19, WL = 43). There were no significant differences between groups in loss to follow-up, demographics, medical characteristics, or baseline psychosocial variables. The average class sizes were also the same between the LD and TD groups. For those who missed sessions, all but one attended a make-up session with a facilitator. The reasons for being lost to follow-up included scheduling conflicts, death in family, family illness, medical reasons, and other reasons.

Each participant completed self-report questionnaires at baseline, 1 month, and 3 months post-treatment. The following instruments were used to assess QOL: Medical Outcomes Study (SF-36), Functional Assessment of Cancer Therapy-Breast (FACT-B), FACT-Cog to assess cognitive function, Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Expanded Scale (FACIT-Sp-Ex), FACIT-Fatigue Scale, Brief Symptom Inventory-Global Severity Index (BSI-GSI), Pittsburgh Sleep Quality Index (PSQI), and demographic factors. In addition, the researchers reviewed medical records and tracked attendance.

The authors used a number of statistical approaches to analyze the data within SAS, including descriptive, linear multilevel modeling for the effects of group and time on QOL, Bonferroni to correct for the 8 QOL outcome measures, t test for post hoc group comparisons, and χ2 to examine group differences. A power analysis determined that 45 participants in each group with a 15% dropout rate would allow for a two-sided significance level of 0.05 and 80% power.

The authors found a significant positive group effect on fatigue (FACIT-F), cognitive function (FACT-Cog), and sleep (PSQI) for both of the intervention groups vs the WL group. There was no group effect for the physical component (PCS), mental component (MCS), function (FACT-B), spiritual well-being (FACIT-Sp-Ex), or psychological distress (BSI-GSI). There were no differences between the LD and TD groups on any outcome measure. There was an effect of time on FACT-B only with increasing scores over time. There were no group x time effects that reached statistical significance (P < 0.011). There were clinically significant but not statistically significant changes in sleep (PSQI) and fatigue (FACIT-F) from baseline at 1-month and 3-month follow-up for the two intervention groups compared to the WL group. (See Table 1.)

 

Table 1: Summary of Results

 

Group effect P values

Time effect P values

Group x time effect

P values

SF-36 PCS

0.154

0.529

0.111

SF-36 MCS

0.020

0.612

0.661

FACT-B

0.076

0.003

0.208

FACIT-F

0.002

0.084

0.321

FACT-Cog

0.001

0.154

0.687

FACIT-Sp-Ex

0.049

0.657

0.462

BSI-GSI

0.051

0.120

0.032

PSQI

< 0.001

0.346

0.303

COMMENTARY

This study indicates that this particular imagery program delivered either live or via telemedicine could have an impact on some important aspects of QOL in breast cancer survivors. The “Envision the Rhythms of Life” program is a unique way of delivering imagery as an intervention. Imagery is commonly studied by having a participant listen to a guided imagery tape or by attending a one-on-one encounter. The techniques used in this study of identifying maladaptive passive imagery and replacing that with active imagery or targeted imagery is regularly a part of imagery programs. It is common to provide imagery either live or remotely by phone or videoconference with individuals. This is the first published study that describes the use of imagery delivered by telemedicine and in a group format. Since this imagery program was delivered in a group format, it is difficult to determine if the results were solely due to the imagery intervention itself or if they also were the result of the social support received in the group setting. In a study published by the authors in 2008, this imagery program was evaluated and showed improvement in various indicators of QOL and reduced stress, but cortisol levels did not significantly improve.1

Information about how the facilitators were trained in imagery or how the curriculum was developed was not provided. Certificate programs in imagery offer didactic and practical experience with supervision helping to ensure quality facilitators. In addition, the facilitators in the “Envision the Rhythms of Life” program were referred to as therapists throughout the manuscript, but the facilitators included a licensed professional counselor and a family practice physician. These professionals have different training backgrounds that will affect their ability to facilitate groups and provide psychological therapy. The group size was 25; ideally therapy groups have 10-12 participants and don’t exceed 15.2 It can be difficult to manage the group and provide individual attention when the group is large. In addition, 4 hours is a long session, particularly for individuals with health conditions such as fatigue.

The statistics collected were appropriate for purpose of the study and the type of data collected. The authors randomized participants to the groups using adaptive randomization in the fashion it was designed to be used.3 This type of randomization is helpful in assuring the groups have similar characteristics. The instruments used in the study have been shown to have good reliability and validity. All of the instruments were subjective measures of quality of life; incorporating objective measures would have strengthened the study results. The authors stated that the study was underpowered to detect differences between the two intervention groups, making it impossible to determine if one intervention was better than the other in improving quality of life.

One study exclusion criteria was “no major psychiatric illness,” but this was not further defined. A systematic review found that up to 66% of breast cancer survivors have depression and up to 33% have anxiety.4 An assessment of these common psychological conditions along with social support would have given greater insight into the impact of the interventions. Practicing imagery outside of the group would also improve outcomes, but adherence to home practice was not measured. The participants may have simultaneously been using other mind-body and complementary therapies that also could have affected QOL lowering or enhanced the impact of the “Envision the Rhythms of Life” program. In one study, use of complementary and alternative therapies was 86% among newly diagnosed breast cancer patients and many used more than one modality.5 Finally, participant gender was not reported in this study. Perhaps it is assumed that all the participants were female. Incorporating men and more participants of color would be an important goal for future studies.

In summary, the results of this study suggest that delivering this imagery program either live or via telemedicine could have an impact on some aspects of QOL among breast cancer survivors. From a clinical standpoint, delivering imagery via telemedicine could be an innovative way to reach cancer survivors in rural settings and make a positive impact on QOL. More research is needed to determine if telemedicine is as effective as in-person delivery of group imagery programs.

REFERENCES

  1. Freeman L, et al. Imagery intervention for recovering breast cancer patients: Clinical trial of safety and efficacy. J Soc Integr Oncol 2008;6:67-75.
  2. Gupta A. Group therapy for psychiatric disorders: An introduction. Mental Health Reviews 2005. Available at: http://www.psyplexus.com/mhr/group_therapy.html. Accessed Nov. 30, 2015.
  3. Kairalla JA, et al. Adaptive trial designs: A review of barriers and opportunities. Trials 2012;13:145.
  4. Maass SW, et al. The prevalence of long-term symptoms of depression and anxiety after breast cancer treatment: A systematic review. Maturitas 2015;82:100-108.
  5. Greenlee H, et al. Complementary and alternative therapy use before and after breast cancer diagnosis: The Pathways Study. Breast Cancer Res 2009;117:653-665.