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

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

The intervention will be conducted during chemotherapy and tailored for each patient. The program will include 1) weight bearing aerobic exercises to maintain the oxygen transport and thereby reduce the decline in VO2max during chemotherapy and 2) strength training exercises to maintain muscle mass and muscle strength. The intervention will last for 9 or 12 weeks, depending on the number of BEP/EP cycles received. The program will consist of two-three one-hour exercise sessions per week, of which most supervised by a personal trainer. The intensity of each exercise sessions will varies from easy (warm-up: 60-70 % of peak heart rate) to moderate/high (between aerobic intervals 60-70% of peak heart rate and during aerobic intervals 85-95 %).

Exercise group

The control group will receive one individual lifestyle counseling session during the first chemotherapy cycle and can perform all activities that they have planned to do during chemotherapy.

Control group

Lene Thorsen, PhD

The present study examine the effects of an aerobic and strength training program on cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the participants will receive the exercise program and the other half will receive one individual lifestyle counseling session. The investigators hypothesize that TC patients in the exercise group will have less reduction in cardiorespiratory fitness during chemotherapy treatment compared to patients in the control group.

Testicular cancer (TC) patients receiving chemotherapy often experience troublesome side-effects during and after treatment. Both aerobic and strength exercise have showed beneficial effects on side-effects during and after treatment in other cancer diagnosis. Knowledge of the effects of physical exercise during and after chemotherapy in TC patients is insufficient and studies are needed. The primary aim is to examine the effects of physical exercise on cardiorespiratory fitness in TC patients during chemotherapy. Secondary aims are to examine the effects of physical exercise on other secondary health outcomes during and three and twelve months after chemotherapy.

The present study is a randomized controlled trial comparing a tailored exercise program consisting of aerobic and strength training during chemotherapy to a control group receiving one individual lifestyle counseling session during the first chemotherapy cycle. The TC patients will be included and assessed before the first cycle of chemotherapy and further assigned to either a exercise group or a control group. The intervention will last for 9 or 12 weeks (depending on the number of bleomycin, etoposide, cisplatin (BEP)/etoposide, cisplatin (EP) cycles received) and it will consists of two-three one-hour sessions per week mostly supervised by a personal trainer. All variables will be assessed pre- and post-intervention, and at three and 12 months follow-up.

Testicular Cancer and Aerobic and Strength Training

Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study

Differences in change in VO2peak from pre- to post-intervention between the exercise group and the control group.

Differences in change in VO2peak from pre-post-intervention to three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of reduced VO2peak at 12 months follow-up in all participants.

Differences in change in pulmonary function (lung capacity, lung volume, diffusion capacity) from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group.

Differences in change in muscle strength from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group.

Differences in change in lean body mass and fat mass from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of unhealthy body composition at 12 months follow-up in all participants.

Differences in change in BMI from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of unhealthy BMI at 12 months follow-up in all participants.

Differences in change in hip- and waist circumferences from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group.

Differences in change in physical exercise from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of being inactive at 12 months follow-up in all participants.

Differences in work ability and sick leave from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of reduced work ability at 12 months follow-up in all participants.

Differences in change in health related quality of life (HRQOL) from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of having reduced HRQOL at 12 months follow-up in all participants.

Differences in change in fatigue from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of having fatigue at 12 months follow-up in all participants.

Differences in change in anxiety and depression from pre- to post-intervention and to three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of having anxiety and depression at 12 months follow-up in all participants.

Differences in change in blood tests from pre- to post intervention and at three and 12 months follow-up in the exercise group and the control group. Examine potential risk factors for endothelia dysfunction, activated coagulation and thrombosis and cardiovascular diseases (metabolic syndrome) at 12 months follow-up in all participants.

Number of participants with adverse events during the exercise intervention.

Norwegian School of Sport Sciences

Oslo University Hospital

Behaviors and Mental Disorders

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Anxiety Disorders

Depressive Disorder

Fatigue

Stomach Neoplasms

Depression

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Quality of Life

Stomach Cancer

A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.

These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week.

We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE.

Exercise education:

Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.

exercise group

Pei-Shan Ho, BSN

Hui-Mei Chen, PhD

Taipei Veterans General Hospital

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Hypothesis:

1. The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
2. The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
3. The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
4. The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

The Effect of Home Based Walking Exercise on Fatigue, Anxiety, Depression, Sleep Quality, Circadian Rhythms and Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.

The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.

The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.

Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.

The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.

Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I\<O) collection from actigraphy.

Taipei Veterans General Hospital, Taiwan

Participants will be offered three live-remote exercise training sessions per week. Each participant in the trial will be provided with the base module twice a week, which will involve a personalized training intensity. This module aims at targeting the participants' HRQOL, which is the first primary endpoint of the trial. Additionally, each participant will receive one out of four specific modules once a week to address their individual main side-effect (based on shared decision-making (SDM)) (second primary outcome). The intervention also includes an educational component about exercise and cancer.

Regular care The control group will receive the same exercise program after the 12 weeks intervention period

Live-remote exercise sessions, personalized to the patients main side-effect

Evelyn Monninkhof, PhD

Anne May, PhD

Background

Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.

Goal of the study:

The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.

Design of the study

In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.

The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.

Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.

Measurements

The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.

Conclusion:

This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively.

SUMMARY

Rationale:

Many cancer patients suffer from long-term treatment-related side-effects like fatigue, low physical functioning, anxiety and/or depressive symptoms, and chemotherapy-induced peripheral neuropathy (CIPN). There is convincing evidence on the beneficial effects of general exercise interventions on these side-effects. However, studies to date generally fail to specifically screen for (long-term) side-effects at baseline and tailor the intervention to these specific side-effects, although larger exercise effects are observed in patients with a high symptom burden at baseline (e.g., with higher levels of fatigue). Larger effects of exercise are also observed for supervised exercise compared to unsupervised exercise. However, two of the most common barriers for attending and complying with supervised exercise are travel distance and time. An effective approach might be to provide live-remote supervision for exercise interventions. In this scenario, patients can receive guidance from a certified exercise specialist through a video-conferencing platform such as Zoom, while performing exercises within the comfort of their own homes. Currently, the effectiveness of live-remote exercise in cancer patients has not been established.

Objective:

The primary objective of the LION RCT is to assess the (cost-)effectiveness of a personalized, live-remote exercise intervention for cancer survivors on Health-Related Quality of Life (HRQOL) and the participants' main, self-reported side-effect. The four side-effects targeted in this study are: 1) fatigue, 2) perceived low physical functioning in daily life, 3) anxiety and/or depressive symptoms, and 4) CIPN.

Study design:

The LION RCT is a randomized controlled trial with two study arms: an exercise group (12 weeks) and a wait list control group. A super umbrella design will be used, allowing us to evaluate four exercise modalities (i.e., exercise modules based on participants' main side-effect) in a wide variety of cancer survivors.

Study population:

For this study, 350 adult cancer survivors treated with systemic chemotherapy (≥ 12 weeks to 1 year after completion of primary treatment of invasive cancer with curative intent) will be recruited independent of their primary cancer diagnosis. Participants will have reported at least one of the following side-effects: fatigue, low physical functioning in daily life, anxiety and/or depressive symptoms, CIPN. Additionally, participants need to be relatively physically inactive, i.e., perform ≤210 minutes/week of moderate-to-vigorous leisure and sports activities.

Intervention:

The intervention consists of three live-remote exercise sessions per week. Participants randomized to the exercise group receive the intervention after the baseline visit and the wait list control participants after the 12-week follow-up visit. A modular approach will be used to tailor the intervention to each participant's specific main side-effect. Each participant will receive the same base module (twice a week) to address HRQOL and in addition one out of four specific modules (once a week) addressing their individual main side-effect. In addition to the live-remote training, participants will be provided with the LION app and an activity tracker (Fitbit) at the start of the intervention to support exercise beyond the supervised program, during holidays and after the end of the intervention. In addition to exercise, the intervention also has an educational component including information about general effects of exercise for cancer patients and why exercise is important for specific side-effects. We consider the provision of such education as an integral part of adequate exercise programming.

After the intervention period of 12 weeks, we follow the patients until 36 weeks. In this follow-up period, also two sub studies take place:

1. Sensor-based guidance sub study (only control patients from Cologne)
2. Live-remote physical fitness and function testing (in all control patients; all sites)

RCT with two study arms: exercise group and wait list control group

Personalized Live-remote Exercise Training for Cancer Survivors

Demonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT

After completion of the study analyses by the study team, the data will be anonymized and made available for sharing requests.

Questionnaires - substudy control patients Cologne

% of sessions that patients wear the sensor - substudy control patients Cologne

% of successful live transfer of sensor data - substudy control patients Cologne

Chester Step test - substudy live-remote testing

Push-up test - substudy live-remote testing

30 sec sit-to stand test - substudy live-remote testing

Plank position holding time - substudy live-remote testing

Time Up and Go (TUG) test - substudy live-remote testing

Single leg stance test with open and closed eyes - substudy live-remote testing

Measured with the summary scale of the EORTC QLQ-C30; min 0- max 100 points; higher scores mean better quality of life

Side-effect 1: Fatigue measured with EORTC QLQ-FA12. According to a standardization procedure the symptom score of all patients will be combined into one symptom score..

Side-effect 2: Anxiety and depressive symptoms measured with Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). According to a standardization procedure the symptom score of all patients will be combined into one symptom score.

Side-effect 3: Physical functioning measured with EORTC QLQ-C30 physical function scale According to a standardization procedure the symptom score of all patients will be combined into one symptom score.

Side-effect 4: CPIN measured with EORTC QLQ-CPIN20. According to a standardization procedure the symptom score of all patients will be combined into one symptom score.

Domains of the EORTC QLQ-C30 (except summary score)

Cancer-Related fatigue measured with the EORTC-FA12

Anxiety and depressive symptoms measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Chemotherapy-induced peripheral neuropathy measured with EORTC QLQ-CIPN-20

2 items of the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire

Single leg stance test with open and closed eyes

Measured with an activity tracker (Fitbit)

Measured twice with blood pressure device

Fat mass and fat free mass with bio-impedance - three centers

The specific inflammatory markers (e.g., cytokines, interleukins) will be decided at the time-point of analyses to be able to include factors according to up-to-date insights and use state-of the art platforms; we will for example use the Olink PEA platform (Oncology and Inflammation Array)

The specific growth factors will be decided at the time-point of analyses to be able to include factors according to up-to-date insights and use state-of the art platforms ; we will for example use the Olink PEA platform (Oncology and Inflammation Array)

Modified Medical Consumption Questionnaire (iMCQ)

Modified Productivity Cost Questionnaire (iPCQ)

Via CASTOR app before and after each session; asked at and at the study visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testicular Cancer and Aerobic and Strength Training	NCT02577172	Testicular Neop...	Exercise group Control group	18 Years - 60 Years	Oslo University Hospital
Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy	NCT04593134	Gastric Cancer	exercise group	20 Years - 90 Years	Taipei Veterans General Hospital, Taiwan
Personalized Live-remote Exercise Training for Cancer Survivors	NCT06270628	Neoplasms	Exercise group	18 Years - 100 Years	UMC Utrecht
Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy	NCT04593134	Gastric Cancer	exercise group	20 Years - 90 Years	Taipei Veterans General Hospital, Taiwan

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