Sulmasy, D.P., Hughes, M.T., Yenokyan, G., Kub, J., Terry, P.B., Astrow, A.B., . . . Nolan, M.T. (2017). The trial of ascertaining individual preferences for loved ones' role in end-of-life decisions (TAILORED) study: A randomized controlled trial to improve surrogate decision making. Journal of Pain and Symptom Management, 54, 455–465.
To test the effectiveness of a nurse-facilitated discussion intervention between patients and their caregivers (surrogates) about the role patients would prefer their surrogates play when they are unable to make decisions
A nurse-led intervention administered by a nurse to dyads of patients with gastrointestinal (GI) cancer and their caregivers (CGs). The nurse compared a patient and a CG responses on a decisional control preferences (DCP) tool and facilitated a discussion between the two about the role a patient would like the CG to play when a patient becomes unable to make decisions. Patients and their surrogates received a Patient-Loved One Decision Making Handout that reflected a patient’s DCP; they also received the advanced directive information. A follow-up call was made at four weeks in which the nurse encouraged them to discuss the patients’ preferences for involving the surrogate in healthcare decisions. In addition, they were reminded to review the handout. Patients and CGs were surveyed at baseline and at eight (± 2) weeks postintervention. The trial is known as The Trial of Ascertaining Individual Preferences for Loved Ones’ Role in End-of-Life Decisions (TAILORED)
Randomized controlled trial
Interventions focusing on improving shared decision-making process (decision control preferences) between patients and their surrogates have favorable effects on surrogate stress and satisfaction. Patients prefer shared decision making over pure substitutive judgment. Although perceived burden increased among the treatment group, they were less stressed and more satisfied. This may suggest that increased burden may not always indicate general deterioration.
Facilitating discussions between patients and caregivers/surrogates about decision-making preferences promotes improvement in certain patients’ and surrogates’ outcomes. These discussions supported with handout are feasible interventions that can be administered by nurses.
Mosher, C.E., Secinti, E., Johns, S.A., O'Neil, B.H., Helft, P.R., Shahda, S., . . . Champion, V.L. (2017). Examining the effect of peer helping in a coping skills intervention: A randomized controlled trial for advanced gastrointestinal cancer patients and their family caregivers. Quality of Life Research, 27, 515–528.
To test the feasibility, acceptability, and efficacy of a spiritual-focused peer helping intervention on dyads of caregivers and patients with gastrointestinal (GI) cancer
Dyads received five weekly 50- to 60-minute telephone sessions simultaneously. Trained PhD students in clinical psychology administered the sessions. The intervention involved that a dyad creates informational handout focusing on QOL for other patients and caregivers, which will be made available as a resource to other patients/caregivers. Dyads received identical handouts of informational resources and a CD for relaxation exercises. Dyads received four sessions; the therapist introduced a session topic each time and asked a dyad about their advice relevant to the topic. Afterward, the dyad reviewed a handout listing evidence-based coping skills related to the topic session and the therapist asked them which skills they thought were most helpful to others. An in-session practice of one or more coping skills was also conducted. Lastly, a dyad was asked to set goals related to the session for the upcoming week, which were evaluated in the subsequent session. The session topics were managing physical symptoms in both session 1 and 2, stress in session 3, and maintaining relationships in session 4. In session 5, a therapist reviewed the handout and asked a dyad to critique and provide final advice for others on coping with the cancer. Assessments were done at 1 and 5 weeks postintervention.
Randomized control trial. An individual external to the study performed the randomization; the trained research assistants administering the assessments were blind to study condition.
Primary outcome:
Secondary outcomes:
Feasibility was assessed by study recruitment and retention rates; acceptability was assessed by post-treatment rating of helpfulness of the intervention.
78% completed all five sessions, showing feasibility and acceptability of the intervention. The dyads rated the sessions as helpful. In mixed regression model analyses, there was a time by group effect on life meaning/peace in the intervention group (d = 0.53, p = 0.01). No significant main effect of study group or time x group on the secondary outcomes (anxiety, depressive symptoms, fatigue, general distress, coping, self-efficacy, or emotional support). There was a significant small main effect of role (as being patient or caregiver) and time on fatigue; patients had more fatigue and caregivers had more anxiety. Caregivers had a small decrease in distress on each follow-up relative to baseline. There was a main effect of role on emotional support, patients reported higher level of emotional support than caregivers. No main effect of group or time x group on CG burden.
Compared to coping skills alone, the five-session intervention focusing on involving peer helping plus coping skills did not impact caregiver outcomes.
Telephone interventions with caregivers/patients may be feasible and acceptable but may not bring about meaningful spiritual benefits if sessions are short and relatively small in number. More research is needed to assess the effect of spiritual-based interventions on caregiver outcomes.
Lopez, G., Liu, W., Milbury, K., Spelman, A., Wei, Q., Bruera, E., & Cohen, L. (2017). The effects of oncology massage on symptom self-report for cancer patients and their caregivers. Supportive Care in Cancer, 25, 3645–3650.
To examine the effect of a massage session on physical, psychological, and global distress among cancer patients and their caregivers
Conventional Swedish massage with unscented hypoallergenic lotion and adjusted for location and pressure based the caregivers feedback to the therapist. The session lasted either 30 or 60 minutes based on caregivers choice. A 60-minute session was recommended for the first session. Music and/or a bolstering pillow could be used based on preference. The majority of caregivers received a 60-minute massage (81.6%).
PHASE OF CARE: Not specified in the report
Pre-/post design. Patients and caregivers.
Edmonton Symptom Assessment Scale (ESAS)
Massage therapy significantly decreased caregivers symptoms of pain, fatigue, sleep, depression, anxiety, drowsiness, appetite, and spiritual pain. The reduction was considered clinically significant (reduction greater than 1) for pain, fatigue, anxiety, well-being, and sleep and for all ESAS subscales (global distress, physical distress, and psychological distress). The duration of massage did not make a significant difference (30 versus 60 minutes) on reduction in symptom burden.
Massage offers as much benefit to caregivers as to patients. The largest improvement for caregivers was in their anxiety, pain, and fatigue. A 30-minute massage seems to be as effective as a 60-minute massage.
Offer massage to patients and their caregivers. Massage seems to improve symptom control (immediate effect). Additional study the accumulative effects of massage on caregivers and identify the "right" frequency and dose. Larger randomized controlled trials would provide additional assessment of the intervention.
Harvey-Knowles, J., Sanders, E., Ko, L., Manusov, V., & Yi, J. (2017). The impact of written emotional disclosure on cancer caregivers' perceptions of burden, stress, and depression: A randomized controlled trial. Health Communication, 33, 824–832.
To investigate whether emotional disclosure improved the well-being of caregivers who care for a spouse who experienced HSCT within the past 1 to 3 years.
Two forms of expressive writing (expressive disclosure [ED] and benefit finding [BF]) versus control (time management). Participants in the ED (prompted to discuss undisclosed thoughts/feelings related to the cancer experience) and BF (prompted to discuss any positive outcomes to the cancer experience) were emailed the same prompts three times, seven days apart. Control group received three slightly different prompts, seven days apart; the prompts asked controls to focus on activities done in past week, past 24 hours, and planned activities for the upcoming week.
Randomized control trial with two intervention groups and one control.
Burden: Zarit Caregiver Burden Scale; Stress: Perceived Stress Scale (PSS); Depression: the Patient Health Questionnaire (PHQ)
Burden: Writing (regardless of writing condition) significantly decreased caregivers burden scores (p < 0.01) at posttest (M = 23.19), compared to pretest (M = 25.44). No significant main effect to intervention.
Stress: No significant reduction in caregivers stress; however, those who had higher than average baseline stress in the control group had significant reduction in their stress as compared to those in the intervention groups.
Depression: A significant main effect: a 0.24 greater reduction in post-test depression among those in the intervention than those in the control. A significant interaction effect, those with higher than average depression at baseline has a significant benefit (2.37 point reduction) from assignment to treatment condition (p < 0.05) as compared to control (0.12 point increase in depression).
Expressive writing appears to be beneficial, regardless of type, to caregivers of survivors of HSCT.
ED and BF writing may decrease caregivers depression. Writing, regardless of type, may improve burden and stress among caregivers of HSCT survivors. This is a feasible and relatively simple intervention to help caregivers.
Frambes, D., Sikorskii, A., Tesnjak, I., Wyatt, G., Lehto, R., & Given, B. (2017). Caregiver-reported health outcomes: Effects of providing reflexology for symptom management to women with advanced breast cancer. Oncology Nursing Forum, 44, 596–605.
To examine the effects delivering reflexology on caregiver (CG) psychological, physical, and social health outcomes (fatigue, anxiety, depression, pain, physical function, sleep disturbances, satisfaction in social roles, and pain interference), and to explore if effect of CG outcomes are moderated by selected CG and/or patient baseline characteristics.
CGs in the intervention group received 4 weeks of training on reflexology. CGs delivered at least one session of reflexology per week for four weeks in a row. The session involved stimulating nine foot reflexes using thumb-walking motion for 15 minutes per foot.
This is a secondary analysis of data obtained from a two-group RCT (called Home-Based Symptom Management via Reflexology for Breast Cancer Patients that was conducted 2011-2016). Outcomes assessed at baseline, week 5 (one week after training completion), and week 11 between CG who delivered reflexology to their patients and those who did not.
PROMIS was used to assess the physical, psychological and social health outcomes. The number of reflexology sessions delivered was based on CG self-report through phone calls during the intervention period and from patients at week 11 after the intervention period.
CGs in the intervention group had improvements in fatigue at weeks 5 (p = 0.02) and 11 (p = 0.05). No other differences between the two groups were noted on any other outcomes. No significant association was found between the number of reflexology sessions delivered and any of the outcomes. Gender, patient-caregiver relationship, and caregiver comorbidity possibly moderated effects of reflexology delivery. Being female in the reflexology group moderated the effect of reflexology delivery; they had better physical functioning. Caregivers who were friends with women with breast cancer reported lower levels of depressive symptoms in the reflexology group. The number of comorbidity conditions was negatively associated with satisfaction with social roles in the control group but not in the reflexology group.
Delivering reflexology to patients by their caregivers may decrease caregiving fatigue; caregivers who are friends of patients may benefit (lower depressive symptoms) from delivering reflexology to patients. Female caregivers may potentially have different effects on their physical functioning (better) than male caregivers.
Consider involving friends alongside familial caregivers. Caregivers’ fatigue may be improved by caregiver involvement in delivering alternative care measures (reflexology) to their loved ones; no other benefits appear to be gained otherwise.
El-Jawahri, A., Greer, J.A., Pirl, W.F., Park, E.R., Jackson, V.A., Back, A.L., . . . Temel, J.S. (2017). Effects of early integrated palliative care on caregivers of patients with lung and gastrointestinal cancer: A randomized clinical trial. The Oncologist, 22, 1528–1534.
To test the effects of early integrated palliative care ([PC] plus oncology care) versus oncology care on caregivers’ distress and quality of life (QOL).
Patients in the intervention group met within the first four weeks of diagnosis with a PC-certified MD or APN and at least once monthly until the patient died; PC providers had the ability to contact patients in the intervention group by phone if an in-person visit was not possible, they also added more visits as needed. The PC visits focused on interventions with patients that were discussed in a different study that was referred to. Caregivers were not required to attend the PC visits but were encouraged to. Seventy-one percent of PC visits were attended by caregivers.
Randomized nonblinded clinical trial. Randomization using 1:1 stratified by cancer type. Researchers/clinicians learned of assignment after it was done by the Office of Data Quality staff.
Caregiver mood and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS); the QOL was assessed using SF-36. Measurement of outcomes occurred at week 12 and week 24 post-enrollment.
At 12 weeks, caregivers in the intervention group has significantly lower total psychological distress (anxiety and mood) assessed by HADS total scale score (adjusted mean difference = -1.45, 95 CI [-2.76, -0.15], p = 0.029; the difference seems to be driven by the lower depression scores on the subscale level (adjusted mean difference = -0.71, 95% CI [-1.38, -0.05], p = 0.036). At 24 months, no significant differences between the two groups for any of the outcomes (total psychological distress, depression, anxiety, and QOL). Using terminal decline model (which factors in missing data and deterioration in caregivers outcomes closer to death), caregivers in the interventions group has significantly lower HADs-total (and lower scores on the subscales, depression and anxiety) (95% CI [4.11, 9.58]). No differences in QOL still under this model between the two groups of caregivers.
Early Integrated PC to patients with incurable cancer decreases their caregivers' psychological distress (anxiety and depression) but not QOL.
This was a compelling study for early palliative care--educating patients and their caregivers about benefits of early PC and addressing that the benefits extend beyond patients.