To describe the underlying mechanisms, clinical presentation, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) severity grading, and strategies to prevent and manage epidermal growth factor receptor inhibitor (EGFRI)-associated skin side effects, emphasizing evidence based practice approaches.

The type of patients addressed was those receiving EGFRIs, including monoclonal antibodies (e.g., cetuximab, panitumumab) and low-molecular-weight tyrosine kinase inhibitor (e.g., gefitinib, erlotinib, lapatinib).

The search strategy in this expert opinion article was not defined.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for late effects.

The article provided a table with results from four randomized controlled trials. Algorithms for the treatment of papulopustular rash, xerosis, hyperpigmentation, and paronychia were provided. Each algorithm was based on the grading defined in the NCI CTCAE (version 4.0, May 2009).

General Skin Reactions

Preventative:

• General preemptive or prophylactic recommendations for all patients starting therapy with EGFRIs include the following.
  • Patient education prior to the start of therapy
  • Lifestyle modifications
    • Use thick alcohol–free emollients for overall skin moisturization (e.g., creams, ointments).
    • Avoid frequent, prolonged, hot showers, and use tepid water when showering and washing dishes to minimize xerosis.
    • Avoid excessive sun exposure.
    • Use a broad spectrum of sunscreens (ultraviolet A [UVA] and ultraviolet B [UVB]).
    • Avoid alcohol-based products (e.g., lotions).

Rash

Preventative:

• The authors developed an algorithm for preventing and managing EGFRI–induced papulopustular rash. The various treatments were based on severity grading in the NCI CTCAE scale.
• Grade 0:
  • Minocycline 100 mg orally once on the day of chemotherapy for the first eight weeks of therapy
  • Doxycycline 100 mg orally BID one day prior to the start of chemotherapy for the first six weeks of therapy, skin moisturizer, and sunscreen (para-aminobenzoic acid [PABA] free, sun protection factor [SPF] ≥ 15, and UVA and UVB protection)
  • 1% hydrocortisone cream BID for the first six weeks of therapy
  • Skin moisturizing cream
  • Give gentle skin care instructions.

Treatment:

• Grade 1:
  • Continue anticancer agent at current dose and monitor for changes in severity.
  • Give hydrocortisone 2.5% cream and clindamycin 1% gel daily.
  • Reassess after two weeks (either by healthcare professional or patient self-report); if the reactions worsen or do not improve, proceed to the next step.
• Grade 2:
  • Continue anticancer agent at current dose and monitor for change in severity.
  • Give hydrocortisone 2.5% cream and doxycycline or minocycline 100 mg BID.
  • Reassess after two weeks (either by healthcare professional or patient self-report); if reactions worsen or do not improve, proceed to the next step.
• Grade 3:
  • Modify dose as per package insert.
  • Obtain bacterial or viral cultures if infection is suspected and continue treatment of skin reactions with the following.
    • Give hydrocortisone 2.5% cream, doxycycline or minocycline 100 mg BID, and prednisone 0.5 mg/kg for five days.
    • Reassess after two weeks. If reactions worsen or do not improve, then dose interruption or discontinuation per the package insert may be necessary.

Xerosis

Prevention:

• The authors developed an algorithm for preventing and managing EGFRI–induced xerosis. The various treatments were based on severity grading using the NCI CTCAE scale.
• Grade 0: Prophylactic therapy with sunscreen SPF (≥ 30), moisturizing creams, gentle skin care instructions, use of tepid water when showering or washing dishes, use of oil-in-water creams, and avoidance of alcohol–based skin care products or antibacterial soaps.

Treatment:

• Grade 1:
  • Continue anticancer agent at current dose and monitor for changes in severity.
  • Apply over-the-counter (OTC) moisturizing cream or ointment to the face BID and ammonium lactate 12% cream to the body BID.
  • Reassess after two weeks (either by healthcare professional or patient self-report); if reactions worsen or do not improve, proceed to the next step.
• Grade 2:
  • Continue anticancer agent at current dose and monitor for changes in severity.
  • Apply OTC moisturizing cream or ointment to the face BID and ammonium lactate 12% cream or salicylic acid 6% cream to the body BID.
  • Reassess after two weeks (either by healthcare professional or patient self-report); if reactions worsen or do not improve, proceed to the next step.
• Grade 3:
  • Modify dose as per package insert; obtain bacterial or viral cultures if infection is suspected.
  • Continue treatment of skin reactions with the following. Apply OTC moisturizing cream or ointment to the face BID, ammonium lactate 12% cream or salicylic acid 6% cream to the body BID, and triamcinolone 0.25% cream to eczematous areas BID.
  • Reassess after two weeks. If reactions worsen or do not improve, then dose interruption or discontinuation per the package insert may be necessary.

Hyperpigmentation

Prevention:

• The authors developed an algorithm for preventing and managing hyperpigmentation. The various treatments were based on severity grading in the NCI CTCAE scale.
• Grade 0: Prophylactic therapy includes applying sunscreen (SPF ≥ 30) to the face, ears, neck, arms, and hands when exposed to the sun, as well as use of hats and protective clothing.

Treatment:

• Grade 1:
  • Continue anticancer agent at current dose and monitor for changes in severity.
  • Ensure no associated dermatitis (e.g., erythema, rash, edema) exists that should be treated with triamcinolone 0.1% cream.
  • Treat with hydroquinone 4% cream BID and use sunscreen.
  • Reassess after two weeks (either by healthcare professional or patient self-report); if reactions worsen or do not improve, proceed to the next step.
• Grade 2:
  • Interrupt treatment until severity decreases to grade 0 to 1.
  • Continue treatment of skin reactions with application of hydroquinone 4% cream BID to affected areas and strict sun protection.
  • Reassess after two weeks (either by healthcare professional or patient self-report). If reactions worsen or do not improve, then dose interruption or discontinuation per protocol may be necessary.

Paronychia

Prevention:

• The authors developed an algorithm for preventing and managing paronychia. The various treatments were based on severity grading using the NCI CTCAE scale.
• Grade 0: Prophylactic therapy with moisturizing creams, gentle skin care instructions, teaching patients to avoid wearing tight shoes that will exert excessive friction and pressure on the periungual tissues, and teaching patients to avoid frequent water immersion or touching harsh chemicals with their hands and feet.

Treatment:

• Grade 1:
  • Continue anticancer agent at current dose and monitor for changes in severity.
  • Use topical antibiotics and vinegar soaks (soaking fingers or toes in a solution of white vinegar in water [1:1 concentration] for 15 minutes daily).
  • Reassess after two weeks (either by healthcare professional or patient self-report); if reactions worsen or do not improve, proceed to the next step.
• Grade 2:
  • Continue anticancer agent at current dose and monitor for changes in severity.
  • Treat with systematic (oral) antibiotics, vinegar soaks, and silver nitrate or Monsel‘s solution, applied weekly.
  • Reassess after two weeks (either by healthcare professional or patient self-report); if reactions worsen or do not improve, proceed to the next step.
• Grade 3:
  • Modify dose as per package insert.
  • Obtain bacterial or viral cultures if infection is suspected and continue treatment of skin reaction with systematic (oral) antibiotics, vinegar soaks, and silver nitrate or Monsel‘s solution, applied weekly; consider nail avulsion.
  • Reassess in two weeks. If reactions worsen or do not improve, then dose interruption or discontinuation per package insert may be necessary.

This expert opinion article cannot be considered a consensus guideline because it lacks clear comprehensive search and design strategies, clear evaluation of evidence, and a description of the method used to apply that evidence in the development of the recommendation.

A variety of interventions have been studied to prevent or manage various EGFRI-induced skin reactions, including papulopustular rash, xerosis, hyperpigmentation, and paronychia. Although 76 references were cited, this is an expert opinion article based on the lack of clear comprehensive search and design strategies, unclear evaluation of the evidence, and lack of description of the method to apply that evidence in development of the recommendation.

The authors commented on the lack of evidence-based practice recommendations for preventing and managing skin reactions caused by EGFRIs. The authors stated, “The overall lack of adequate data from prospective RCTs and lack of evidence-based standardized guidelines is reflected by differences in treatment methods utilized by clinicians.” The authors also stated, “The relative paucity of clinical data arising from prospective, large, and placebo-controlled randomized controlled trials has been the major limitation of the currently available treatments.”

Considering the frequent use of EGFRIs, healthcare providers should be familiar with these toxicities, as well as available prevention and management strategies.

Implications for nursing practice include using the tables and algorithms in this article as practical tools to prevent or manage several types of EGFRI-induced skin reactions.  

To evaluate the effect of 600 mg and 1200 mg oral gabapentin pretreatment for the prevention of postoperative catheter-related bladder discomfort (CRBD) in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT)

Patients were randomized to three groups. Group I received four placebo capsules. Group II received two capsules of 300 mg gabapentin and two identical placebo capsules. Group III received four capsules of 300 mg gabapentin. All patients received the study drug orally, with sips of water, one hour prior to administration of anesthesia. Lumbar subarachnoid block was administered with 2.5 ml 0.5% hyperbaric bupivacaine. An anesthesiologist unaware of group assignment observed patients in the Postanesthesia Care Unit (PACU) at 1, 2, 4, 6, 12, and 24 hours.

• The sample was composed of 100 patients.
• Mean patient age was 52.2 years.
• Of all patients, 79% were male and 21% were female.
• All patients had been diagnosed with a bladder tumor.

• Single site
• Inpatient
• United States

Active antitumor treatment

Randomized controlled double-blind trial

• Four-point scale, to record severity of bladder discomfort
• Observations of postoperative nausea, vomiting, and any adverse effect (e.g., sedation, dizziness, ataxia, tinnitus, diplopia, vertigo) related to the study drug

• At 1, 2, and 24 hours after surgery, patients in group II, who received 600 mg gabapentin, had significantly lower incidence of CRBD (p < 0.0001) than did patients in the control group (group I).
• At all time points, the incidence of CRBD was significantly lower (p < 0.0001) in patients receiving 1200 mg gabapentin (group III) than in the control group (group I).
• At 4, 6, 12, and 24 hours, the incidence of CRBD was significantly lower (p < 0.0001) in patients receiving 1200 mg gabapentin (group III) than in group II.
• Compared to the severity of CRBD in group I, the severity of CRBD was significantly lower (p < 0.0001) in groups II and III.

Pretreatment with gabapentin reduces bladder discomfort in patients with an indwelling postoperative catheter. Gabapentin 1200 mg is more effective than gabapentin 600 mg in decreasing the incidence and severity of CRBD.

• The study had risk of bias due to sample characteristics. The sample was primarily male, though the male-to-female ratio was similar in all three groups.
• Findings are not generalizable.

To decrease the postoperative discomfort of patients undergoing catheterization after transurethral resection of bladder tumor, nurses may want to advocate for the preoperative use of 1200 mg gabapentin.

To evaluate the efficacy of aprepitant in treating chemotherapy-induced vomiting when given as an additional antiemetic to children receiving highly emetic chemotherapy

All patients received ondansetron at 0.15 mg/kg IV then dexamethasone at 0.15 mg/kg IV 30 minutes prior to chemotherapy. Oral ondansetron was given at 0.3 mg/kg every eight hours, and oral dexamethasone at 0.15 mg/kg was given every eight hours until 48 hours after the completion of chemotherapy. In the treatment group, patients weighing 15–40 kg received aprepitant capsules of 80 mg for one hour before chemotherapy on days 1–3, and patients weighing 41–65 kg received 125 mg on day 1 then 80 mg on days 2–3. The control group received placebo capsules.

• N = 93 (50 in treatment group, 43 in control group)  
• MEDIAN AGE = 13 years (range = 5–18 years)
• MALES: 69 (72%), FEMALES: 27 (28%)
• KEY DISEASE CHARACTERISTICS: Hodgkin lymphoma, osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, and adenoid cystic carcinoma
• OTHER KEY SAMPLE CHARACTERISTICS: Received any highly emetic chemotherapy protocol (ABVD, VAdC, or VAC)

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: New Delhi, India

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Randomized, double-blinded, placebo-controlled study

• In a diary, patients or their guardians recorded vomiting episodes, chemotherapy-related toxicities, food and fluid intake, and rescue antiemetic medication use.
• Febrile neutropenia information was obtained from medical records.
• Vomiting was categorized according to the National Cancer Institute's (NCI's) guidelines (mild, moderate, or severe).
• Toxicities were evaluated according to NCI Common Terminology Criteria for Adverse Events.

In the acute phase, significantly less moderate and severe vomiting occurred in treatment group compared to the control group (38% versus 72%, p = 0.001). There was a significantly higher rate of complete response in the treatment group compared to the control group (48% versus 12%, p < 0.001). There was significantly less food and fluid intake in the control group than the treatment group (p = 0.04 and p = 0.03, respectively). In the delayed phase, there was no significant difference between the treatment and control groups in regard to moderate or severe vomiting or complete response. There was significantly less fluid intake in the control group versus the treatment group (p = 0.002), but there was no difference in food intake. In the overall phase, there were no grade 3 or 4 adverse events, and there was no difference in the number of rescue medications used in the groups. The incidence of febrile neutropenia was the same between the treatment and control group.

Oral aprepitant appeared to be safe, and no major adverse events were reported. It significantly reduced vomiting in the acute phase of highly emetic chemotherapy treatment when given in combination with ondansetron and decadron in a pediatric population. However, it did not help in the delayed phase.

• Small sample (< 100)
• Measurement validity/reliability questionable
• Other limitations/explanation: The measurement of all outcomes (vomiting, food and fluid intake, and adverse events) relied on the reports of patients or guardians in a diary, and events may have been over- or under-reported. In addition, the sample size was smaller than the power analysis determination (103 patients were needed per arm to detect a significant difference).

Oral aprepitant may decrease vomiting in pediatric patients during the acute phase of highly emetic chemotherapy, but more studies are needed.

In phase III, placebo-controlled studies, lubiprostone 24 mcg twice daily was compared to placebo. Studies 1, 2, and 3 comprised a two-week drug-free period followed by treatment with lubiprostone 24 mcg twice daily for four weeks, followed by randomization to continue lubiprostone or placebo.

Open-label studies used lubiprostone 24 mcg twice daily. Three studies of long-term clinical safety assessed lubiprostone administered for 12 months in patients with chronic idiopathic constipation.

Phase III Studies

• Patients were included in the study if they had constipation, defined as fewer than three spontaneous bowel movements per week plus a six-month history of at least one other Rome II criteria for functional constipation.
• Study 1 reported on a sample of 242 patients. Mean patient age was 48.6 years. The sample was 90% female and 86% Caucasian.
• Study 2 reported on sample of 237 patients who were predominantly female and Caucasian.
• Study 3 reported on a sample of 128 patients with chronic constipation.

Open-Label Studies

• Three studies reported on a sample of 871 patients with chronic idiopathic constipation.
• Mean patient age was 51 years. Nineteen percent of the sample (n = 163) was aged 65 years or older.
• The sample was 86% female and 87% Caucasian.

• Phase III studies
  • Studies 1 and 2: double-blind, placebo-controlled
  • Study 3: placebo-controlled randomized controlled trial (RCT)
• Open-label studies

• In studies 1 and 2, the primary endpoint was frequency of spontaneous bowel movements (BMs) after initiation of double-blind treatment.
• In study 3, a responder was defined as having three or more spontaneous BMs per week during lubiprostone therapy and was converted to nonresponder status (fewer than three spontaneous BMs per week) during the randomized phase for the placebo group.

Study 1 and 2

• Spontaneous BMs increased during all four weeks of lubiprostone treatment in both studies. In study 1, frequencies ranged from 5.1 to 5.7 in the lubiprostone group and 2.8 to 3.5 in the placebo group (p < 0.002 at all weeks). Results were similar for study 2.
• Time to spontaneous BM was shorter in the lubiprostone group. In study 1, spontaneous BM occurred in 56.7% of patients in the lubiprostone group within 24 hours of the first dose compared to 36.9% in the placebo group (p= 0.0024). In study 2, spontaneous BMs occurred in 69.9% of patients in the lubiprostone group within 24 hours of the first dose compared to 31.9% in the placebo group (p < 0.0001).

Study 3

• Spontaneous BMs increased from 1.36 per week at baseline to 6.25, 5.94, 5.52, and 6.2 per week during weeks 1, 2, 3, and 4, respectively (p < 0.0001 at all weeks).
• During the randomization phase, spontaneous BMs progressively declined for the placebo group. At week 7, frequency of spontaneous BMs was 5.59 for the lubiprostone group (p = 0.0223 ) versus 3.04 in the placebo group (p = 0.0223) compared to baseline.

Open-Label Studies

• Lubiprostone reduced abdominal bloating, abdominal discomfort, and severity of constipation over six to 12 months of treatment, and significant improvements were reported for constipation severity, bloating, and abdominal discomfort scores (p < 0.001).
• Although the incidence of adverse events was low overall, incidence of nausea was higher. Older adults had fewer adverse events.

Placebo-controlled RCTs demonstrated lubiprostone was well tolerated and not associated with severe adverse effects. However, incidence of nausea was higher. Comparative studies with other therapies are needed.

• The duration of constipation was not described.
• Information related to history of previous types of therapies used to treat constipation was lacking.
• The studies lacked a control group.
• Data were from publications of abstracts only. No peer journal articles were reviewed.
• No studies included patients with cancer.

To determine the effects of a supportive educational program based on the COPE model on caring burden and quality of life in family caregivers of women with breast cancer

Caregivers randomly were assigned to the experimental or control group. The experimental group had two educational sessions within the first nine days of caregiving and had a follow-up phone call between these two sessions. The education included problem solving, goal setting, learning how to get help for problem solving, and review and discussion of problems faced and actions taken. Study assessments were completed at baseline and at 30 days after study entry. Instruments were completed by questioning.

• N = 64
• MEAN AGE = 38 years
• MALES: 36%, FEMALES: 64%
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of caregivers were spouses or children of the patient. None had healthcare training. Most had limited formal education and low income.

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: Iran

• RCT

• Caregiver quality-of-life questionnaire 
• World Health Organization quality-of-life questionnaire
• Caregiving burden questionnaire (Ziret et al.)

Quality-of-life scores after the intervention were higher in the experimental group in physical (p = .001), psychological (p = .017), and environmental (p -.047) domains, and overall (p < .001). Burden was significantly lower after the intervention in the experimental group (p < .001). In the experimental group, burden declined and scores in all quality-of-life measures improved, while burden scores increased and quality-of-life scores declined in the control group.

Findings showed that the program implemented was associated with improved quality of life and reduced caregiver burden.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement validity/reliability questionable
• Questionable protocol fidelity
• Other limitations/explanation: Tools used are not well-known instruments, and as these appeared to be directly administered by researchers. If bias may have been introduced is not clear. Internal consistency of instruments ranged from 0.59–0.92. No description of approaches to ensure treatment fidelity was provided. Usual care in the control group is not described. If sessions were provided individually or in a group setting is not clear.

Findings suggest that a supportive, psychoeducational intervention was beneficial to caregivers with improvement in quality of life and reduction in caregiver burden. Nurses can assist caregivers in working with them around problem solving, goal setting, and provision of supportive interactions. The intervention consisted of two educational sessions and one phone call in a one-month period.

To research the effect of extracorporeal shock wave therapy (ESWT) in patients who had secondary lymphedema after treatment for breast cancer

In this study, ESWT was performed four times over two weeks. Four patients received manual lymphatic massage and pneumatic compression along with ESWT, and three patients received only ESWT. The three participants did not receive massage or compression because they reported that it was not successful in the past. It does not seem that there was a follow-up after the post-treatment measurements on patients.

• N  = 7    
• MEAN AGE =  52 (SD = 9.9)
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Mean length of time that patients suffered lymphedema was 25.3 months (SD = 12.7). All patients had stage III lymphedema.   
• OTHER KEY SAMPLE CHARACTERISTICS: All patients had received chemotherapy and radiation. Four had received combination physical therapy.

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Department of Rehabilitation, Ewha Womans University School of Medicine, Seoul, Korea

• PHASE OF CARE: Late effects and survivorship

• Prospective trial study

To determine lymphedema presence, a limb-to-limb difference of 2 cm or more had to exist at a single measurement site in addition to lymphatic obstruction as determined lymphoscintigraphy. The following subjective measurements were used: hardness of the skin, edema of the involved upper extremity, and sensory impairment. Each was measured using visual analog scale (VAS), with 10 points being most severe. Objective measurements used were volume of the upper extremity, thickness of the skin, and circumference of the upper extremity. Volume measurement was a direct technique was used as derived from Archimedes’ principle.

All patients experienced a reduction after four treatments of ESWT. The mean reduction volume was 188.6 ml (p = .018). Those who received physical therapy and ESWT showed a reduction rate of 39.46%, and those without physical therapy showed a rate of 34.25%. The difference was not significant. The mean decrease in circumference was 1.1 cm, with a range of 0.4–1.7 cm.The mean decrease in skin fold was 7.7 mm, with a range of 4–16 mm. The mean subjective edema was decreased significantly from 7.3 to 5.6 (p = .027). No patients experienced side effects.

ESWT appears to be effective in treating stage III secondary lymphedema in women after being treated for breast cancer. The circumference and thickness of patients' arms decreased after treatment. However, the sample size is very small and therefore is not representative of a diverse population of people.

• Small sample (< 30)

ESWT treatment may provide a noninvasive treatment alternative for patients with stage III lymphedema that has a high rate of effectiveness.

To test the initial efficacy, acceptability, and feasibility of a dyadic (patient–caregiver) psychosocial, phone-delivered intervention to improve the quality of life of the families of patients with advanced lung cancer within one month of the first cancer treatment

The dyads were randomly assigned to a usual medical care (UMC) or a six-week intervention group. Intervention patients and caregivers received separate standardized, tailored manuals. Manuals addressed self-care, stress and coping, symptom management, effective communication, problem solving, and maintaining and enhancing relationships. Patients and caregivers shared half of the topic information, but other content was tailored to the patient or caregiver role. Patients-tailored content included ways to balance autonomy with asking for and accepting support, sharing support needs, and ways to show caregiver appreciation. Caregiver-tailored content included ways to minimize patient overprotection, show effective communication, and ways to support patient self-care goals. Intervention dyads participated in six weekly 60-minute telephone counseling sessions aimed at alleviating caregiver burden with a trained interventionist who reviewed weekly patient and caregiver homework and manual content. The interventionist mentored participants through sessions and homework assignments to reinforce session skills for patients and caregivers. Participants in UMC and intervention groups completed six paper-and-pencil surveys at baseline and eight-weeks after baseline.

• N = 39 patient–caregiver dyads (20 dyads in intervention group, 19 dyads in UMC group)
• MEAN AGE = Patients; 68.17 years (SD = 10.30 years, range = 38–87 years), caregivers; 51.10 years (SD = 10.24 years, range = 35–70 years)
• MALES: Patients (26%); caregivers (31%), FEMALES: Patients (74%); caregivers (69%)
• KEY DISEASE CHARACTERISTICS: 84% of sample had stage 3 or 4 non-small cell lung cancer; 16% had extensive-stage small cell lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were mostly white (85%) and educated with at least some college credits (86%); 62% was unemployed or retired; caregivers were mostly female (69%) and educated with at least some college credits (95%); most were middle-aged (mean = 51.10 years, SD = 10.24 years) and employed at least part- time (77%); 51% of caregivers were spouses or partners, and others were siblings or the adult sons and daughters of patients

• SITE: Single site
• SETTING TYPE: Outpatient oncology and palliative care clinic  
• LOCATION: New York City comprehensive cancer center with range of services

• PHASE OF CARE: Advanced lung cancer within one month of treatment initiation (any form of therapy)
• APPLICATIONS: Elder care and palliative care 

Randomized clinical trial

• Six-item Patient Reported Outcomes Measurement Information System (PROMIS), a short-form depression measure to assess the negative moods and views of self for the past week
• Two-item Zarit Burden Interview (ZBI) Short Form 
• Six-item Treatment Self-Regulation Questionnaire (TSRQ) to assess patient autonomy for engaging in self-care
• Five items developed by Pierce et al. used to assess caregivers’ autonomous motivation
• 38-item Likert scale measure based on the work of Lorig et al. (1996) used to measure competence (self-efficacy)  
• Four-item measure used to measure relatedness (quality of the caregiver-care recipient relationship)

The study's recruitment rate was 60%, which is comparable to rates reported in other telephone-based cancer dyadic interventions, supporting the feasibility of recruiting advanced LC patients on active treatment and their caregivers for this trial. Patient and caregiver telephone-session participation was 90%. Participants rated the intervention as relevant, convenient, and helpful. Retention was excellent, and dyads completed the majority (88%) of homework assignments. This suggests a highly acceptable intervention. Large effect sizes were found for the impact of the intervention on outcomes of patient and caregiver depression, anxiety, and caregiver burden as contrasted with UMC group outcomes. Large effect sizes for impact of the intervention were also found for additional patient and caregiver outcomes relevant to competence and relatedness and caregiver free choice to provide patient care. Highly depressed and anxious caregivers, identified at the baseline assessment in the intervention group, showed greater improvements in psychological functioning than did those in the UMC group.

This pilot study demonstrated the feasibility and acceptance of a six-session, telephone-based dyadic psychosocial intervention developed for patients with advanced lung cancer and their caregivers and its positive effects on their rates of depression, anxiety, and caregiver burden.

• Small sample (< 30)
• Baseline sample/group differences of import
• Measurement/methods not well described
• Other limitations/explanation: Sample was primarily white and was relatively well-educated; the ability to generalize findings to other populations was limited

Telephone-based interventions addressing patients with late-stage lung cancer and their caregivers may improve overall dyadic quality of life. This study indicated support for separate patient and caregiver sessions to address private issues posing challenges in a dyadic discussion. Additional research focused on separate sessions balanced with dyadic sessions may strengthen the evidence for telephone interventions.

To test the effectiveness of two telephone-delivered psychosocial interventions for maintaining and improving quality of life

The first intervention was by-telephone interpersonal counseling (TIP-C) delivered weekly for eight weeks to prostate cancer survivors and every other week for eight weeks to partners. The second intervention involved eight weekly health education attention condition (HEAC) sessions delivered by telephone.

• The sample included 71 men (survivors) and 70 partners.  
• Mean age of survivors was 66.99 years and mean age of partners was 61.13 years.
• Of the survivors, 100% were male. Of the partners, 5.7% were male and 92.9% were female.
• All survivors had been diagnosed with prostate cancer.

• Single site
• Home setting

• Phase of care: long-term follow-up
• Clinical applications: late effects and survivorship, eldercare

Repeated-measures experimental design

• Center for Epidemiological Studies Depression Scale   
• Positive and Negative Affect Schedule
• UCLA Prostate Cancer Index
• Multidimensional Fatigue Inventory
• Social Well-Being Scale
• Perceived Social Support from Family Scale
• Spiritual Well-Being subscale of Quality of Life Instrument–breast cancer version

Improvements in depression, negative affect, stress, fatigue, and spiritual well-being were significantly greater for survivors receiving the HEAC intervention than for those receiving the TIP-C intervention.Compared to partners in the TIP-C intervention, partners in the HEAC group showed significantly greater improvements in depression, fatigue, perceived social support from family members, social well-being, and spiritual well-being.

Both interventions in this study were effective in improving multiple dimensions of quality of life for men with prostate cancer and their partners.

• The study had a small sample size (fewer than 100 participants).
• Length of time since diagnosis was highly varied in the sample and needs can be expected to differ based on this.
• Predominantly Caucasian sample
• Baseline QOL was high.

Both interventions were effective, but additional research is needed. Health education may be just as effective or more effective in helping patients and caregivers than individualized counseling.

To test the effectiveness of two telephone-delivered psychosocial interventions for maintaining and improving quality of life (QOL).

The first intervention was a telephone interpersonal counseling (TIP-C) intervention delivered weekly for eight weeks to prostate cancer survivors and every other week, for four times, to partners. The second intervention included eight weekly health education attention conditions (HEACs) delivered by telephone.

• Seventy-one survivors (100% male) and 70 partners (5.7% male, 94.2% female) were included.
• Mean age was 66.99 for survivors and 61.13 for partners.
• Patients were survivors of prostate cancer.

• Single site  
• Home
   

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for late effects and survivorship and elderly care.
   

The study used a repeated measures experimental design.

• Center for Epidemiologic Studies Depression Scale (CESD)    
• Positive and Negative Affect Schedule (PANAS)
• University of California, Los Angeles Prostate Cancer Index (UCLA PCI)
• Multidimensional Fatigue Inventory (MFI)
• Social Well-Being Scale
• Perceived Social Support–Family Scale (PSS–Fa)
• Quality of Life, Breast Cancer version–Spiritual Well-Being subscale 

Improvements in depression, negative affect, stress, fatigue, and spiritual well-being were significantly higher for survivors in the HEAC intervention than in the TIP-C intervention. Partners in the HEAC intervention showed significantly greater improvements in depression, fatigue, social support from family members, social well-being, and spiritual well-being compared to partners in the TIP-C intervention.

Both interventions were effective in improving multiple dimensions of QOL for men with prostate cancer and their partners.

The study had a small sample size, with less than 100 participants.

Both interventions were effective, but further research is needed.

This intervention provided telephone-delivered psychosocial interventions.

One group received six weeks of telephone-delivered counseling (TIP-C) sessions based on interpersonal psychotherapy/counseling principles, covering the following topics.

• Cancer education
• Social support
• Awareness and management of anxiety symptoms
• Role transitions

These phone calls averaged 34 minutes.

A second group received six weeks of telephone-delivered, self-managed exercise protocol information. The exercise protocol consisted of engaging in regular, low-impact exercise (e.g., walking for a prescribed number of minutes at least four times per week). These phone calls averaged 11 minutes.

A third group received six weeks of attention control (AC) printed information about breast cancer with brief weekly phone calls averaging seven minutes. This group did not receive counseling or encouragement to exercise.

Data were collected at baseline (T1), one week after the final call (T2), and one month after the final call (T3).

• The study reported on a convenience sample of 96 women with breast cancer and 96 partners (N = 192).
• Participants were randomized to three groups, stratified by stage and treatment.
  • Group 1 consisted of 38 women and 38 partners.
  • Group 2 consisted of 21 women and 19 partners.
  • Group 3 consisted of 33 women and 30 partners.
• There were no significant differences between groups for treatment, stage, history of depression, participation in support groups or counseling, and use of antidepressants or antianxiety medications.

The study used an experimental design: three-wave repeated measures with a between-subjects factor (treatment group).

• Positive and Negative Affect Schedule (PANAS) PLUS
• Index of Clinical Stress to make eight-item composite index of anxiety
• Instruments used have established reliability and validity.

Both telephone counseling and exercise conditions helped to significantly reduce anxiety in women and their partners (p < 0.001). The AC group did not evidence the same improvement in decreased anxiety, and their partners’ anxiety scores increased. The authors reported mixed-model ANOVA significant effect for time (p = 0.001), no significant main effect for treatment group, and significant group x time interaction (p = 0.01).

The intervention required special training needs of a psychiatric nurse counselor with oncology expertise to deliver the telephone counseling sessions. These 34-minute (on average) phone calls per weekly session (x 2—one per patient and one per partner) required more than one hour per week per couple of time to deliver the intervention.