A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India

Purpose. Advanced cancer patients with disease progression develop cachexia. Nevertheless, cancer patients at nutritional risk have shown improved body weight and quality of life with oral nutritional supplements. Method. This was a randomized controlled trial in adult female cancer patients (n = 63) attending palliative clinics, with symptoms of cachexia. Eligible patients were randomly distributed into control (n = 33) and intervention (n = 30) groups. Both groups were provided with nutritional and physical activity counseling, but the intervention group received an additional 100 g of Improved Atta (IAtta) for 6 months daily consumption. This study was designed to assess the efficacy of IAtta (with counseling) in enhancing the health status of cachexic patients. Anthropometric measurements, dietary intake, physical activity level and quality of life parameters were assessed at baseline, after 3 months, and at the end of 6 months. Results. Patients in the control group (n = 15) had significantly decreased body weight ( P = .003), mid–upper-arm circumference ( P = .002), and body fat ( P = .002) by the end of intervention. A trend of body weight gain in the intervention group (n = 17; P = .08) and significant increase of body fat ( P = .002) was observed; moreover, patients reported a significant improvement in fatigue ( P = .002) and appetite scores ( P = .006) under quality-of-life domains at the end of intervention. Conclusions. Embedding a nutrition-sensitive intervention ( IAtta ) within Indian palliative care therapy may improve quality of life and stabilize body weight in cancer cachexia patients.

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Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

10.21203/rs.3.rs-19471/v1 ◽

2020 ◽

Author(s):

Toshimi Takano ◽

Ayako Matsuda ◽

Noriko Ishizuka ◽

Yukinori Ozaki ◽

Koichi Suyama ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Cancer Patients ◽

Emotional Functioning ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

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The impact of tailored nutrition intervention and dietary counseling on body weight in female cancer cachexia patients in India.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.31_suppl.67 ◽

2014 ◽

Vol 32 (31_suppl) ◽

pp. 67-67

Author(s):

Neha Kapoor ◽

Ihab Tewfik ◽

Jane Naufahu ◽

Sundus Tewfik ◽

Rakesh Garg ◽

...

Keyword(s):

Quality Of Life ◽

Palliative Care ◽

Body Weight ◽

Cancer Patients ◽

Muscle Mass ◽

Cancer Cachexia ◽

Intervention Group ◽

Nutritional Counseling ◽

Female Cancer Patients

67 Background: The prevalence of malnutrition, amongst cancer palliative patients, is 81%. As cancer progresses, patients’ develop malnutrition owing to metabolic changes and ill-effects of treatment. The aim of this study was to improve nutritional status of female cancer patients and their quality of life by counseling and providing nutrient rich natural food (IAtta). Methods: Female cancer patients (n=45) attending palliative care clinic (AIIMS, New Delhi); with symptoms of cachexia were randomly distributed into control (Group one, n=23) and intervention group (Group two, n=22). Both groups were provided with nutritional counseling while the intervention group also received 100grams of IAtta, to be consumed daily for three months. Anthropometric measurements [weight, muscle mass, percentage body fat (%BF) and mid upper arm circumference (MUAC)], dietary intake (two day dietary recall) and quality of life (European Organisation for Research and Treatment of Cancer-Quality of Life C30 Questionnaire) were assessed at baseline and after three months. Data was analysed using paired t-test and Wilcoxon signed-rank test on the variables assessed. P-value < 0.05 was considered statistically significant at 95% confidence interval. Results: Patients in group one had significantly decreased body weight (p= 0.001), muscle mass (p= 0.021), MUAC (p= 0.005) and %BF (p= 0.001) by end of three months. While patients in group two reported significant improvement in fatigue (p= 0.001) and appetite loss score (p= 0.002) under quality of life domains. Conclusions: Nutritional counseling along with IAtta food supplementation helps in stabilising weight and improves quality of life of cancer cachexia patients undergoing palliative care treatment. Clinical trial information: RP- 02/17.06.2013. [Table: see text]

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Evaluation of the Efficacy and Safety of an Exercise Program for Persons with Total Hip or Total Knee Replacement: Study Protocol for a Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18136732 ◽

2021 ◽

Vol 18 (13) ◽

pp. 6732

Author(s):

Giuseppe Barone ◽

Raffaele Zinno ◽

Erika Pinelli ◽

Francesco Benvenuti ◽

Laura Bragonzoni ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Control Group ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Total Knee

Total hip replacement (THR) and total knee replacement (TKR) are among the most common elective surgical procedures. There is a large consensus on the importance of physical activity promotion for an active lifestyle in persons who underwent THR or TKR to prevent or mitigate disability and improve the quality of life (QoL) in the long term. However, there is no best practice in exercise and physical activity specifically designed for these persons. The present protocol aims to evaluate the efficacy and safety of an exercise program (6 month duration) designed for improving quality of life in people who had undergone THR or TKR. This paper describes a randomized controlled trial protocol that involves persons with THR or TKR. The participant will be randomly assigned to an intervention group or a control group. The intervention group will perform post-rehabilitation supervised training; the control group will be requested to follow the usual care. The primary outcome is QoL, measured with the Short-Form Health Survey (SF-36); Secondary outcomes are clinical, functional and lifestyle measures that may influence QoL. The results of this study could provide evidence for clinicians, exercise trainers, and policymakers toward a strategy that ensures safe and effective exercise physical activity after surgery.

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Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

BMC Cancer ◽

10.1186/s12885-021-08333-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Toshimi Takano ◽

Ayako Matsuda ◽

Noriko Ishizuka ◽

Yukinori Ozaki ◽

Koichi Suyama ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Cancer Patients ◽

Emotional Functioning ◽

Controlled Trial ◽

Intervention Group ◽

Cytotoxic Chemotherapy ◽

Randomized Controlled ◽

Self Help

Abstract Background A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, a post-hoc subset analysis suggested that the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy. Trial registration UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014.

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Effects of Targeted Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors During and After Treatment: An Exploratory Randomized Controlled Trial

Journal of Adolescent and Young Adult Oncology ◽

10.1089/jayao.2013.0021 ◽

2014 ◽

Vol 3 (2) ◽

pp. 83-91 ◽

Cited By ~ 14

Author(s):

Lisa J. Bélanger ◽

W. Kerry Mummery ◽

Alexander M. Clark ◽

Kerry S. Courneya

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Young Adult Cancer Survivors ◽

Randomized Controlled ◽

Adult Cancer Survivors ◽

Print Materials ◽

Young Adult Cancer

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Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

Canadian Respiratory Journal ◽

10.1155/2002/106262 ◽

2002 ◽

Vol 9 (4) ◽

pp. 253-259 ◽

Cited By ~ 21

Author(s):

Robert L Cowie ◽

Margot F Underwood ◽

Cinde B Little ◽

Ian Mitchell ◽

Sheldon Spier ◽

...

Keyword(s):

Quality Of Life ◽

Emergency Department ◽

Randomized Controlled Trial ◽

Asthma Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

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Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2005.01.271 ◽

2005 ◽

Vol 23 (25) ◽

pp. 6027-6036 ◽

Cited By ~ 102

Author(s):

Patsy Yates ◽

Sanchia Aranda ◽

Maryanne Hargraves ◽

Bev Mirolo ◽

Alexandra Clavarino ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Randomized Controlled Trial ◽

Functional Assessment ◽

Controlled Trial ◽

Intervention Group ◽

Randomized Controlled ◽

Cancer Related Fatigue ◽

Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

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Effect of medical Qigong on cognitive function, quality of life, and a biomarker of inflammation in cancer patients: a randomized controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-011-1209-6 ◽

2011 ◽

Vol 20 (6) ◽

pp. 1235-1242 ◽

Cited By ~ 121

Author(s):

Byeongsang Oh ◽

Phyllis N. Butow ◽

Barbara A. Mullan ◽

Stephen J. Clarke ◽

Philip J. Beale ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Cognitive Function ◽

Cancer Patients ◽

Controlled Trial ◽

Randomized Controlled

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Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

10.2196/preprints.29640 ◽

2021 ◽

Author(s):

Florie FILLOL ◽

Ludivine PARIS ◽

Sébastien PASCAL ◽

Aurélien MULLIEZ ◽

Christian-François ROQUES ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Waist Circumference ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

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