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)

• N = 137 dyads, 46 of which were patients with GI cancer and their surrogates   
• AGE: 61.2 for all the dyads.
• MALES: 57%  
• FEMALES: 43%
• CURRENT TREATMENT: Chemotherapy, other
• KEY DISEASE CHARACTERISTICS: Patients with advanced GI cancers excluding those with isolated hepatic metastasis. The study also included dyads of surrogates and patients who had ALS.
• OTHER KEY SAMPLE CHARACTERISTICS: Spoke English

• SITE: Multi-site. Johns Hopkins GI oncology clinic, GI surgical clinic, and ALS clinic; the GI oncology clinic at the University of Chicago 
• SETTING TYPE: Multiple settings    
• LOCATION: United States

• PHASE OF CARE: End-of-life care
• APPLICATIONS:  Palliative care

Randomized controlled trial

• Decision Control Preference Scale-Modified to assess surrogates’ perception of their loved one’s preference for surrogates’ involvement.
• Horowitz Impact of Events Scale to assess surrogates’ stress
• Family Decision Making Self-Efficacy scale to assess self-efficacy
• Zarit-Short Form to assess caregiver burden
• A single-item question to assess satisfaction

• Improved patient-surrogate concordance on the DCP scale after intervention, but not statistically significant. Significant increase in likelihood of surrogates endorsing shared decision making in the intervention group from baseline to follow-up (OR_adj = 2.05, p = 0.03) as compared to control (OR_adj = 1.44, p = 0.28). Increased endorsement of shared decision making from baseline to follow-up in the treatment group (51% from 38%) as compared to control (48% from 40%).
• Surrogate stress declined significantly from baseline (23.1, SD = 15.8) to follow-up (20.8, SD = 15.3) in the treatment group (p = 0.046). At the eight-week follow-up, the treatment group stress score was 20% lower than that of control (adj ratio of means = 0.8, p = 0.04).
• No significant change in surrogates self-efficacy or significant difference between treatment and control group
• Caregiver burden increased from baseline to follow-up in the treatment group (12.5, SD = 6.5, to 14.7, SD = 8.1; p < 0.01).
• A significantly higher percent of the treatment group (71%) were satisfied than in the control (52%, p = 0.02).

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.

• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• The intervention was not described well, how long and whether administered by nurses who were trained in a standardized way or to follow a protocol during the discussion. Patients with ALS and GI cancer were combined so it is not possible to know results just for patients with cancer.

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.

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.

• N = 50 dyads with 50 caregivers
• AGE: 55.3 years in the intervention group, 52.4 years in the control group
• MALES: 34%  
• FEMALES: 66%
• CURRENT TREATMENT: Chemotherapy, radiation, immunotherapy, surgery
• KEY DISEASE CHARACTERISTICS: Advanced GI cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Only one dyad from Roudbush VA Medical Center, all others from Indiana University Simon Cancer Center, at least one member of the dyad reported moderate to severe distress (Distress Thermometer score of 3 or higher).

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Indiana University Simon Cancer Center and the Roudebush VA Medical Center in Indianapolis

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Palliative care

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:

• The 8-item meaning/peace subscale of the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp) well-being scale to assess meaning in life and peace

Secondary outcomes: 

• Patient Reported Outcomes Measurement Information System (PROMIS) to assess caregiver fatigue
• The 6-item PROMIS short form depression to assess caregiver depressive symptoms
• The 6-item PROMIS anxiety measure to assess caregiver anxiety
• The 4-item PROMIS short form emotional support measure to assess caregiver perceived availability of emotional support
• The Distress Thermometer to assess caregiver distress
• The subscale of the Measure of Current Status (MCOS) to assess caregiver self-efficacy for coping
• Zarit Burden Interview-short form to assess personal and role strain
• Caregivers rated their frequency of volunteer work on a five-point scale.

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.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Largely Caucasian and middle class. Study is underpowered, effects of intervention may have been attenuated by baseline relatively low distress and elevated meaning/peace; control group received coping skills intervention, which may have diluted the differences relative to a usual care group when compared to the intervention group.

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.

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%).

• N = 87 at baseline, 40 completed post
• AGE: 52.9 years (SD = 12.8)
• MALES: 25.3%  
• FEMALES: 74.7%
• KEY DISEASE CHARACTERISTICS: Patients had various cancers, but mostly with breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients and their caregivers were studied. Patient population disease and treatment characteristics not described in report.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: MD Anderson Integrative Medicine Center

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.

• Small sample (< 100)
• Baseline sample/group differences of import        
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: Massage was available only to those who could pay for it. Significant difference existed between caregivers who completed the post ESAS and those who did not (higher anxiety and psychological distress). 87 caregivers filled the baseline data and only 40 filled the post data. Study was conducted in a comprehensive cancer center.

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.

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.

• N = 64   
• AGE: 56 years
• MALES: 12.5%  
• FEMALES: 87.5%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: HSCT in the past three years
• OTHER KEY SAMPLE CHARACTERISTICS: The majority were Caucasian (92%); in a long-term relationship (average 28 years); patients were cared for at a comprehensive cancer center

• SITE: Single site   
• SETTING TYPE: Other: caregivers were reached by mail
• LOCATION: Fred Hutchinson Cancer Research Center Database of HSCT survivors in Seattle, WA

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care

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.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• 20% rate of attrition

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.

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.

• N = 180   
• AGE: 54
• MALES: 56%  
• FEMALES: 44%
• CURRENT TREATMENT: Combination radiation and chemotherapy, immunotherapy
• KEY DISEASE CHARACTERISTICS: Advanced breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Most were employed and had some college education, majority were Caucasian, had access to phone, were able to speak English

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Eight cancer centers in central Michigan and Illinois

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care, palliative care

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.

• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%

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.

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.

• N = 275   
• AGE: Mean = 57 years (SD = 13.6)
• MALES: 31%  
• FEMALES: 69%
• CURRENT TREATMENT: Not applicable, other
• KEY DISEASE CHARACTERISTICS: Incurable lung cancers or noncolorectal gastrointerstinal cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers were 18 years and older, mostly White, Catholic, married to the patient, with a college education. Able to respond in English with minimal use of translator (minimal use not defined)

• SITE: Single site   
• SETTING TYPE: Outpatient; if patient were admitted to Massachusetts General Hospital, the PC team followed them during hospitalization
• LOCATION: Massachusetts General Hospital

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

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.

• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Other limitations/explanation: The nature of the PC visits and what they involved were not described in the article. Authors referred reader to a previous research report. The fact that the number of PC visits may have varied widely between patients in the intervention group, calls to question if the frequency, not only the visit, affected the outcomes.

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.