Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Testicular Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Physical activity counseling

Lene Thorsen, PhD

The purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. It is hypothesized that the patients are able to complete the intervention with individual adjustments.

Physical Activity and Testicular Cancer

Physical Activity and Testicular Cancer - a Pilot Study: Feasibility and Effects of a Program Including Information, Counseling and a Physical Activity Program for Patients With Testicular Cancer During and After Chemotherapy

Change in 1RM from baseline to post-intervention and follow-up

Change in VO2max from baseline to post-intervention and follow-up

Change in body composition from baseline to post-intervention and follow-up

Change in metabolic disease markers from baseline to post-intervention and follow-up

Change in CRP from baseline to post-intervention and follow-up

Change in CK from baseline to post-intervention and follow-up

Change in CK-MB from baseline to post-intervention and follow-up

Change in myoglobin from baseline to post-intervention and follow-up

Change in work status from baseline to post-intervention and follow-up

Change in fatigue from baseline to post-intervention and follow-up

Change in anxiety and depression from baseline to post-intervention and follow-up

Change in quality of life from baseline to post-intervention and follow-up

Norwegian School of Sport Sciences

Gjensidigestiftelsen

The Research Council of Norway

Oslo University Hospital

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Disease Progression

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Quality of Life

Micronutrients

All Drugs and Chemicals

Trace Elements

Patients in the intervention group will be given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.

Patients in the control group will be given whole wheat flour (100 g) daily along with nutritional counseling and physical activity counseling for six months.

Improved Atta is a multi macro- micronutrient bread mix. Patients will be given 100 grams of Improved Atta (to make unleavened bread) everyday for consumption for six months.

Improved Atta

Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.

Wheat flour

Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.

Dietary counseling for 30 minutes will be imparted to all patients on every hospital visits by the nutritionist. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) will be encouraged in their daily diets.

Nutritional counseling

Neha Kapoor, PhD

Ihab Tewfik, PhD

Investigators are evaluating the nutritional role of IAtta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. Dietary and physical activity counseling will be imparted every fortnight to patients.

Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life in free-living patients suffering from cancer cachexia.

Patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. Intervention group patients will collect 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months.

Dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.

Nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients

To Evaluate the Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Delaying Progression of Cachexia to Refractory Cachexia in Adult Cancer Patients in Indian Population

Body weight in kilograms will be assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

MUAC in centimeters will be measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper will be noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage will be calculated using body density value in Siri equation.

SFT will be measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.

IMS-FFQ will be used to assess patient's daily energy (kcal), protein (g) and fat (g) intake at baseline, mid-intervention and end of intervention (6 months).

Food frequency questionnaire is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns. IMS-FFQ (Indian Migrant Study- Food Frequency Questionnaire) consists of 184 commonly consumed food items and is validated among the rural and urban Indian population.

Two day 24 hour dietary recall will be used to assess patient's daily energy (kcal), protein (g) and fat (g) intake at baseline, mid-intervention and end of intervention (6 months).

24 hour dietary recall is an accurate method to understand patients' eating patterns.

PGSGA will be used to assess patient nutritional status (category: well nourished, malnourished \& severely malnourished) at baseline, mid-intervention and end of intervention (6 months).

PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.

IMS-PAQ will assess patients' physical activity throughout the day. Investigators will asses physical activity at three time points during the study: baseline, at 3 months of intervention and at 6 months end of intervention. IMS-PAQ is a validated questionnaire on both Indian rural and urban population. Patients' will report every activity performed with the average amount of time spent for each activity in the questionnaire. Thereafter, investigators will calculate the average calories spent by every patient in the whole day.

EORTC-QLQ- C30 (European Organization for Research \&Treatment of cancer) questionnaire will be used to analyse patients' quality of life at baseline, mid- intervention and at the end of intervention period. A score will be calculated for all the15 domains covered in the questionnaire of 30 questions.These domains will be analysed and compared for the outcome in the two groups.

Haemoglobin levels (g/dl) will be monitored at baseline, at three months and at the end of intervention (6 months).

Serum albumin (g%) levels will be monitored at baseline, at three months and at the end of intervention (6 months).

C-reactive protein (mg/L) levels will be monitored at baseline and at the end of intervention (6 months).

All India Institute of Medical Sciences, New Delhi

University of Westminster

Research Scholar

Patients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.

Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.

Improved Atta is a multi macro- micronutrient bread mix. Patients were given 100 grams of Improved Atta (in the from of unleavened bread) everyday for consumption for six months.

Dietary counseling for 30 minutes was imparted to all patients on every hospital visits by the researcher. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) was encouraged in their daily diets.

Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.

The main aim of the study is to assess the effectiveness of tailored nutritional intervention in delaying the progression of cachexia to refractory cachexia in adult female cancer patients.

The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and physical activity counselling) for six months, improved the anthropometric and biochemical indices in free-living patients suffering from cancer cachexia.

Patients were randomly distributed into two groups i.e. control and intervention group. 30 patients were allocated in intervention group and received nutrient rich bread mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 33 patients were allocated in the control group who received only dietary and physical activity counseling. Patients in the intervention group collected 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients were advised regarding their dietary habits at every clinician visit for 6 months.

Dietary counseling for 30 minutes was imparted to all patients on each visit by the researcher. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.

Nutritional, biochemical, quality of life and anthropometric estimations were assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Patients' daily energy, carbohydrate, protein and fat intake were calculated using food frequency (Indian Migrant study food frequency questionnaire- IMS-FFQ) questionnaire and two day 24 hour recall data. PG-SGA questionnaire was used to monitor patient nutritional status throughout the study.

EORTC-QLQ- C30 questionnaire was used to analyse patients' quality of life and asked personally by the researcher.

Haemoglobin and serum albumin levels were assessed at the start of the study, after 3 months and at 6 months of intervention for all patients.

Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day.

Anthropometric estimations included body weight, mid upper arm circumference and four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac).

Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

To Study the Impact of Nutritional Intervention in Delaying the Progression of Cachexia to Refractory Cachexia in Female Cancer Patients: A Study Based in India

Body weight was assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

MUAC was measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper was noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage was calculated using body density value in Siri equation. SFT was measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.

Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment were used to assess patient nutritional status at baseline, mid-intervention and end of intervention (6 months).

Food frequency questionnaire and 24 hour dietary recall is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns.IMS-FFQ consists of 184 commonly consumed food items and was validated among the rural and urban Indian population. PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.

Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day. We assessed physical activity at three time points during the study: baseline, at 3 months of intervention and at 6 months end of intervention.

IMS-PAQ is a validated questionnaire on both Indian rural and urban population.

EORTC-QLQ- C30 questionnaire was used to analyse patients' QoL at baseline, mid- intervention and at the end of intervention period.

Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).

Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).

Skin and Connective Tissue Diseases

Breast Neoplasms

Bernardine Pinto, Ph.D.

This study aims at testing the efficacy of a physical activity (PA)intervention in an outpatient oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact control) vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff) over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years.

Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.

Secondary aims include examining a) the effects of the two interventions on participants' moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12 months, and c) the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients.

Background: With improved survival rates, there are growing numbers of cancer survivors. These individuals report impaired physical functioning, anxiety and depressed mood, fatigue, and reduced quality of life after treatment. In addition, they may be at increased risk for cardiovascular disease, obesity, osteoporosis and future cancers. Prior research has demonstrated that moderate-intensity physical activity (PA) can improve enhance physical functioning, reduce fatigue and improve vigor among cancer patients and those who have completed medical treatments. These efforts have not been integrated with the healthcare system. Data support the role of primary care providers in promoting PA among their sedentary patients; the role of oncologists in encouraging patients to become physically active has not been examined.

Objectives: This study aims at testing the efficacy of a PA intervention in an outpatient oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact control) vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff) over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years.

Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.

Secondary aims include examining a) the effects of the two interventions on participants' moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12 months, and c) the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients.

Study Design: A randomized, controlled trial will be conducted in outpatient oncology practices in Rhode Island. Within this setting, the oncologists and research staff will offer a 3 month, theoretically-based intervention to increase moderate-intensity PA among 300 sedentary women aged 18 and older who attend cancer follow-up visits. The unit of randomization will be at the patient level.

Cancer Relevance: If the data are promising, the study lays the groundwork for improving cancer recovery by integrating a brief PA intervention into follow-up care for cancer survivors. This study offers the potential to improve the follow-up care for cancer survivors by encouraging them to becoming physically active, to help reduce the emotional and physical side-effects of cancer and its treatment, as well as possibly reduce their risk for other chronic diseases such as cardiovascular disease and osteoporosis.

Physical Activity Promotion in Cancer Follow-Up Care

Physical Activity Promotion In Cancer Follow-up Care

Brown University

The Miriam Hospital

Group receives face-to-face physical activity counseling.

20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions.

Kristina H Karvinen, PhD

Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors.

Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group

Effectiveness of a Cancer Center Based Physical Activity Intervention

The primary outcome is to examine the effectiveness of a cancer center based physical activity intervention on increasing physical activity as measured by step counts on a pedometer.

The secondary outcome is to examine the effectiveness of a cancer center based physical activity counseling intervention on improving quality of life in breast cancer survivors.

East Carolina University

Assistant Professor

Prostatic Neoplasms

Prostatic Diseases

Pelvic floor exercise program and general exercise programming

Pelvic floor exercises and standard care (physical activity counseling)

General exercises will be prescribed along with a specialized pelvic floor program

Pelvic floor exercise program

A general progressive resistance exercise program

General exercise

Physical Activity Counseling

Margaret L McNeely

Chris Sellar

Margaret McNeely

Nathan Hoy, MD

Howard Evans, MD

The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.

The investigators aim to conduct a trial examining the feasibility and the effects of a combined pelvic health rehabilitation and exercise program that can be delivered both in-person and virtually in individuals who have been treated with prostatectomy for prostate cancer. This hybrid format will support equitable program delivery regardless of location of residence. To address issues faced by men with prostate cancer, the investigators propose an intervention (offered virtually and in-person) that includes: 1) online education to support continence, sexual and overall health; 2) a group exercise fitness program that considers the needs and restrictions specific to the early post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle exercise retraining to promote continence and sexual recovery.

Main objectives of this study

1. Determine the feasibility, defined as the acceptability and appropriateness, of a combined pelvic health rehabilitation and exercise fitness program that can be delivered both in-person and virtually.
2. Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care.

Secondary objectives of this study

1. To determine the effects of the program on cardiometabolic indicators in comparison with usual care.
2. To determine the effects of the program on general fitness, secondary outcomes of urinary continence, sexual function, self-efficacy, and cancer symptom burden, in comparison with usual care.

The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.

Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer

Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)

Data will be housed on the University of Alberta's Dataverse

The number of participants completing the study including all planned outcomes

Percentage of participants who are eligible and agree to participate

Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad

16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning

13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning

Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life

11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden

6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy

Sit-to-stand: mean number completed in 30 seconds

Shoulder Range of Motion: mean value in degrees

One-leg stance test: mean time in seconds

Six-minute walk test: mean distance in metres

Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Physical Activity and Testicular Cancer	NCT01749774	Testicular Canc...	Physical activi...	18 Years -	Oslo University Hospital
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients	NCT02561143	Cachexia Cancer	Improved Atta Wheat flour Physical activi... Nutritional cou...	18 Years -	University of Westminster
Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients	NCT02350855	Cachexia Cancer	Improved Atta Nutritional cou... Physical activi...	18 Years -	University of Westminster
Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients	NCT02350855	Cachexia Cancer	Improved Atta Nutritional cou... Physical activi...	18 Years -	University of Westminster
Physical Activity Promotion in Cancer Follow-Up Care	NCT00230711	Breast Cancer	Physical activi...	18 Years -	The Miriam Hospital
Effectiveness of a Cancer Center Based Physical Activity Intervention	NCT01173861	Breast Cancer Quality of Life Physical Activi...	Physical activi...	18 Years -	East Carolina University
Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer	NCT06072911	Prostate Cancer Incontinence Metabolic Disea...	Pelvic floor ex... General exercis... Physical Activi...	18 Years -	University of Alberta
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients	NCT02561143	Cachexia Cancer	Improved Atta Wheat flour Physical activi... Nutritional cou...	18 Years -	University of Westminster
Effectiveness of a Cancer Center Based Physical Activity Intervention	NCT01173861	Breast Cancer Quality of Life Physical Activi...	Physical activi...	18 Years -	East Carolina University

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