Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors

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Primary Outcome Measures:

  • Change in Multidimensional Fatigue Inventory (MFI) score [ Time Frame: Baseline, Week 6 ]

    Multidimensional Fatigue Inventory (MFI) is a brief (20-item) self-report instrument that assesses 5 dimensions (subscales) of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Respondents indicate their level of agreement with fatigue related statements on a 5 point scale ranging from “Yes, that is true” = 1 to “No that is not true” = 5. Possible scores for each subscale range from 4 (no fatigue) to 20 (maximum fatigue). The primary outcome measure for this study will be the total of four MFI subscales (general fatigue, physical fatigue, reduced activity, and reduced motivation).

Secondary Outcome Measures:

  • Change in Patient-Reported Outcome Measurement System (PROMIS) Fatigue Scale score [ Time Frame: Baseline, Week 6 ]

    The PROMIS Fatigue Scale is an 7-item self-report scale. Respondents indicate how tired they feel by answering fatigue related questions (such as “How often did you feel tired?”) on a scale of 1 (never) to 5 (always). The summary score ranges from 7 to 35 with higher values equating to increased levels of fatigue.

  • Change in plasma IL-6 [ Time Frame: Baseline, Week 6 ]

    To examine the effects of SMT on the pro-inflammatory cytokine IL-6, blood will be drawn at each study visit and the plasma levels of IL-6 will be compared between prior to treatment and at treatment completion.

  • Change in Quality of Life, Enjoyment, and Satisfaction Questionnaire – short form (Q-LES-Q) score [ Time Frame: Baseline, Week 6 ]

    The Q-LES-Q short form is a 16-item, patient-administered instrument, which asks participants to rate their satisfaction with 13 specific areas of life, specifically, overall sense of well-being, medication, and overall life satisfaction and contentment during the past week. Responses are given on a 5-point scale where 1 = very poor and 5 = very good. Items 1-14 are added in order to obtain a summary score while the last two items are stand alone questions. Total scores range from 14 to 70 and higher scores indicate greater satisfaction with life.

  • Change in Quick Inventory of Depressive Symptomatology – Self-Report (QIDS-SR) score [ Time Frame: Baseline, Week 6 ]

    The QIDS-SR is a 16-item questionnaire covering nine diagnostic symptom domains that characterize a major depressive episode (sleep disturbance, sad mood, changes in appetite/weight, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, and psychomotor agitation/retardation). The total score can range from 0 -27. A score of 1-5 equate to no depression while a score of 21-27 indicates very severe depression.

  • Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale score [ Time Frame: Baseline, Week 6 ]

    The GAD-7 is a 7-item, well-validated patient self-report scale of anxiety. Participants respond to statements to indicate how often they have been bothered by specified symptoms of anxiety (such as “feeling nervous, anxious, or on edge). Response choices include 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day. Total scores range from 0 to 21 with higher scores indicating increased anxiety.

  • Change in circadian variation of activity [ Time Frame: Baseline, Week 6 ]

    Activity level will be assessed by examining circadian variation (daily biologic cycles) of activity. Daily activity of each participant will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.

  • Change in step count [ Time Frame: Baseline, Week 6 ]

    The number of steps the participant takes each day will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.

  • Change in sleep duration [ Time Frame: Baseline, Week 6 ]

    The number of hours the participant sleeps each night will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.

  • Change in sleep latency [ Time Frame: Baseline, Week 6 ]

    The amount of time it takes for the participant to fall asleep will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.

  • Change in Automated Monitoring of Symptom Severity (AMoSS) survey score [ Time Frame: Baseline, Week 6 ]

    AMoSS is a smartphone app designed for longitudinal evaluation of mood states and sociability. Using this type of technology may help to better understand the day-to-day impact of SMT on the lives of cancer survivors with CRF, by means of a short pop-up survey that assesses sadness, anxiety, fatigue, irritability, and energy. Mood/fatigue will be assessed daily with reminders provided by the app via an alert.

Fatigue is the most common, and one of the most devastating symptoms among patients with cancer. According to the National Comprehensive Cancer Network (NCCN), cancer-related fatigue (CRF) is “a distressing, persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity”. Fatigue occurs across the spectrum of cancer types and treatments. CRF has a negative impact on all areas of function, including mood, physical function, work performance, social interaction, family care, cognitive performance, schoolwork, and community activities. CRF has been rated as more troublesome and to have a greater negative impact on quality of life than other cancer-related symptoms such as pain, depression, and nausea. CRF can persist for months or years after cancer therapy is completed.

Meaningful, evidence-based treatment options for CRF are limited. Over 50% of patients with cancer have used a complementary and alternative medicine (CAM) approach for symptom management and quality of life. One of the widely employed CAM interventions is massage therapy. Most of the studies investigating massage for patients with cancer focus on depression, anxiety, or pain as the outcomes of interest. A previous investigation of breast cancer survivors reported decreases in mood symptoms and an improvement in fatigue, however, CRF was not the primary outcome measure. This randomized clinical trial will test the efficacy of Swedish massage therapy (SMT) vs. an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy, and who are on androgen depletion therapy. Participants will receive weekly treatments for 6 weeks.

The aims of the study are as follows:

Aim 1: To conduct a feasibility study to determine whether a 6-week SMT intervention can decrease CRF among prostate cancer survivors who have received both radiation and androgen deprivation therapy and have CRF.

Aim 2: To determine whether the hypothesized decrease in CRF is due to SMT modulating the immune system of subjects with CRF. The researchers hypothesize that SMT will decrease plasma concentrations of IL-6 (a pro-inflammatory cytokine) more than LT and that the decrease in plasma IL-6 will mediate the decrease in fatigue as assessed with the MFI.

Aim 3: To determine whether SMT improves self-reported quality of life, depression, and anxiety more than LT, as assessed (respectively) by the Quality of Life, Enjoyment, and Satisfaction Questionnaire – short form (Q-LES-Q), the Quick Inventory of Depressive Symptoms – Self-Report (QIDS-SR), and the Generalized Anxiety Disorder 7-item (GAD-7) scale.

Aim 4: To evaluate the peripheral physiological changes associated with treatment of CRF. The researchers predict that treatment with SMT will cause a progressive increase in wearable measures of activity and step count, improved sleep quality (duration and latency), and decrease in pulse over 6 weeks when compared to baseline measures.

Aim 5: To determine if valid and useful tests of SMT effectiveness for treating CRF can be obtained through daily self-report ratings of fatigue and continuous monitoring of physiological signs. The researchers predict that SMT will cause a significant decrease in daily self-ratings of fatigue and mood when compared to baseline ratings and that the decreases in daily self-ratings of fatigue and mood observed with SMT will correlate with changes in Q-LES-Q, QIDS-SR, GAD-7 scores obtained at in-person visits as well as physiological signs.